ZAPP MEDICAL ALLOYS MEDICAL TECHNOLOGY

(1)

(2)

CONTENTS

03 ZAPP MEDICAL ALLOYS 04 LOGISTICS AND QUALITY 05 PRODUCT PORTFOLIO 06 DELIVERY FORMS

07 SPECIAL IMPLANT MATERIALS 08 IMPLANT MATERIALS MADE OF

TITANIUM

09 MATERIALS FOR INSTRUMENTS 10 MATERIALS FOR INSTRUMENTS –

MARTENSITIC

11 SPECIAL MATERIALS FOR MEDICAL AND DENTAL

(3)

PAGE 3/12 ZAPP MEDICAL ALLOYS SOLUTION PROVIDER ZAPP MEDICAL ALLOYS

For decades now, the companies of the Zapp Group have been supplying semi-finished metal products made of stainless steel, titanium and titanium alloys, nickel and cobalt-based alloys, as well as a large number of special materials. Building on this experience with a view to becoming a specialist in medical technology needs, the alignment of Zapp Medical Alloys’ organization is unique to the steel industry: it concentrates exclusively on your metal semi-finished product requirements. Our staff provides you with expert support to help you select the ideal material for your specific application. Across the complete spectrum of product forms – from wires, bars, profiles, strips and sheets to tubes – we offer a compre-hensive, continuously expanding range of material solutions comprising our own products as well as trade activities.

YOUR PURCHASING DEPARTMENT BENEFITS

Along with our extremely broad product portfolio we are able to offer you the technical service and development capabilities of an established manufacturer, saving you the time and expense of a long search for the right partner. Joint developments to address special requirements are part of our everyday business. Take advantage of our expertise:

_Comprehensive application engineering support from the initial idea right through to serial production _Special material variants created by combining

material-specific product characteristics and sophisticated pro-cess engineering to induce particular mechanical/tech-nological properties

_A sales team trained in commercial technology to sup-port your product selection process

(4)

PAGE 4/12 ZAPP MEDICAL ALLOYS | LOGISTICS AND QUALITY LOGISTICS

The comprehensive distribution and logistics network of the entire Zapp Group is your worldwide guarantee of outstanding service and of the availability of our semi-finished products. From America to Scandinavia to China, in production facilities, service centers and sales offices around the globe, our own staff and affiliated partners are at your service to respond as quickly as possible to your delivery requests. We overcome time-consuming logistical obstacles through the continuous expansion of our distribution network and service centers. Selected partners ensure reliable transport over land, air and sea to deliver our materials to your location on-time. Express delivery services are also available for direct delivery of samples and small lots to meet short-term needs. We offer a wide range of packaging options specifically designed to facilitate transport and protect quality from the shipping department to the final destination.

QUALITY

Products made to satisfy the highest quality demands form the core of our corporate philosophy. It takes raw materi-als from qualified production sources to manufacture safe and reliable products for the medical and dental industry. Zapp guarantees documented product traceability from the original melt right through to the final semi-finished product. The systematic archiving of documentation and retention samples enables us to assure you unequivocally of the quality of our products, even decades later. And, thanks to our expert staff’s many years of experience in research, development and manufacturing, we offer un-surpassed product reliability that satisfies the extremely sensitive demands placed on medical semi-finished pro-ducts. We combine validated manufacturing processes with integrated test technology and continuous monitor-ing by our own trained team of specialists to maintain these high material quality standards. Our products are clearly designed to meet your specifications and comply with qualitative requirements from the relevant standards for medical semi-finished products. Beyond regulatory requirements, the highest quality levels are achieved through specifically targeted chemical compositions in combination with highly specialized process engineering technology.

LOGISTICS AND QUALITY

(5)

PAGE 5/12 ZAPP MEDICAL ALLOYS | PRODUCT PORTFOLIO

THESE ALLOYS

Special Implant Materials

Austenite, AISI 316LVM 1.4441 Austenite, Alloy 734 1.4472 Austenite, nickel free 9.9007 Co-Ni-Cr-Mo-Alloy, Implant 9.9035 Co-Cr-Mo, Forging Alloy 9.9135 Co-Cr-W-Ni-Alloy 9.9605 Pure Titanium grade 1 3.7025 Pure Titanium grade 2 3.7035 Pure Titanium grade 3 3.7055 Pure Titanium grade 4 3.7065 Titanium Alloy Ti6AL4V ELI 3.7165 Titanium Alloy Ti15Mo 9.9150 Titanium Alloy Ti6AlNb7 9.9367 Instrument grades

Martensite 13 % Cr, AISI 420A 1.4021 Martensite 13 % Cr, AISI 420B 1.4028 Martensite 13 % Cr, AISI 420X 1.4031 Martensite 13 % Cr, AISI 420C 1.4034 Martensite 13 % Cr, AISI 420C (+S) 1.4035 Martensite 13 % Cr, AISI 420F mod. 1.4197 Martensite 17 % Cr, AISI 430F 1.4104 Martensite 17 % Cr, AISI 431 1.4057 Martensite 17 % Cr, AISI 440A 9.9440 Martensite 17 % Cr, AISI 440B 1.4112 Martensite 17 % Cr 1.4122 Martensite 17 % Cr, AISI 440C 1.4125 Precipitation hardenable steels

Special Alloy 17-4-PH 1.4542 Special Alloy 17-7-PH 1.4568 Special Alloy XM-16, Alloy 455 1.4543 Austenite 1.4310 Special materials Austenite, nickel-free 1.4456 Co-Ni-Cr-Mo-Alloy, dental 9.9035 Ferrite 1.4105 Austenite 1.4301 Austenite 1.4303 Austenite 1.4305 Austenite 1.4306 Austenite 1.4571

DEVELOPED AND MANUFACTURED FOR YOU

Bars 0.7 - 100 mm

drawn, peeled, ground, polished chamfered, centered, pointed annealed, cold worked, stress released

straightness 0.5 mm/m on demand up to 0.2 mm/m special surface roughness up to Ra < 0.3 µm ISO 286-2 in tolerances ISO h11 to ISO h05 integrated crack detection

Fine Wire and Premium Wire 0.07 – 20 mm

bright drawn, diamond drawn, specially coated ISO 286-2 in tolerances ISO h11 to ISO h05 crack detected products

Profiles

0.3 x 0.3 mm – 63 x 6.35 mm milled, rolled, drawn dull, bright, extreme bright square, hexagonal, octagonal ½, ⅓ and ¼ tube

implant-special shapes »near net shape«

precision profile according drawing water-jet-cut blank

Precision Strip

thickness from 0.02 – 2.50 mm width from 2 – 1066 mm sheets up to 6.00 mm thickness cold worked, final annealed tempered

Plates

square or in circular blanks water-jet-cut

Tubes

thin-walled, seamless < 20 mm drawn, ground

FOR YOUR APPLICATION

bone screw bone nail bone plate intra-medullary nail joint replacement shoulder, hip, knee spinal implant endoprosthesis dental implant maxillofacial surgery vascular surgery cerclage fixation system surgical needle instrument bone saw abrasor rotating instrument dental burr dental cutter orthodontic brace scalpel scissors laboratory equipment stamping and bending part

(6)

PAGE 6/12 ZAPP MEDICAL ALLOYS | DELIVERY FORMS WIRE

in coils, on metal carriers, in barrels, on spools PREMIUM WIRE in barrels, on spools BAR in commercial lengths, in special lengths PROFILE in coils, in bars, on spools PRECISION STRIP in coils, on spools, in straightened bars, in sheets PLATES in commercial lengths, tailor made BLANKS in defined geometries, in circular blanks, tailor made

TUBES

in commercial lengths, in special lengths

(7)

PAGE 7/12 ZAPP MEDICAL ALLOYS | SPECIAL IMPLANTAT MATERIALS OUTSTANDING QUALITY ADVANTAGES

_large and product-based selection of steel materials, non-ferrous metals, pure titanium and titanium alloys _chemical compositions in compliance with the

requirements of listed national and international standards

_inducement of customer-specific material properties through precisely targeted chemical analysis and special manufacturing processes

_guarantee of optimized properties relative to corrosion (high PRE), bio-compatibility, fatigue strength and slag purity in re-melted materials

_substitution of nickel (by manganese and nitrogen) in special nickel-free materials for use with patients who have nickel allergies

_extremely high corrosion resistance through the use of special cobalt-based alloys

SPECIAL IMPLANT MATERIALS

Brand Name Material- Chemical Composition (Mass-%)

norms C Si Mn P S Cr Ni Mo Nb Cu N Fe

Ergste®_1.4441LA _{ASTM F138} ASTM F139 ISO 5832-1

min.

max. 0.030 0.75 2.00 0.025 0.01 17.00 19.00 13.00 15.00 2.25 3.00 - 0.50 0.10 bal Ergste®_1.4472RN _{ASTM F1586}

ISO 5832-9 min. max. 0.080 0.75 2.00 4.25 0.025 0.01 22.00 19.50 9.00 11.00 2.00 3.00 0.25 0.80 0.25 0.25 0.50 bal Ergste®_9.9007CN _{ASTM F2581} _min.

max. 0.15 0.25 0.20 0.60 9.50 12.50 0.020 0.01 16.50 18.00 0.05 2.70 3.70 - 0.25 0.45 0.55 bal Ergste®_1.4456CA _Zapp-

Special Analysis min. max. 0.10 1.00 16.00 20.00 0.05 0.05 16.00 20.00 0.20 1.80 2.50 - 3.00 < 0.1 bal

norms C Si Mn P S Cr Ni Mo W Fe Ti N Co

Ergste®_9.9035 _{ASTM F562}

ISO 5832-6 min. max. 0.025 0.15 0.15 0.015 0.01 21.00 19.00 33.00 37.00 9.00 10.50 - 1.00 1.00 - bal Ergiloy®_9.9135HL _{ASTM F1537} (Alloy 1) ISO 5832-12 (Low C) min. max. 0.14 1.00 1.00 - - 26.00 30.00 1.00 5.00 7.00 - 0.75 - 0.25 bal Ergiloy®_9.9605XL _{ASTM F90}

ISO 5832-5 min. max. 0.15 0.40 2.00 0.04 0.030 21.00 19.00 9.00 11.00 - 14.00 16.00 3.00 - - bal

(8)

PAGE 8/12 ZAPP MEDICAL ALLOYS | IMPLANT MATERIALS MA DE OF TITANIUM OUTSTANDING QUALITY ADVANTAGES

_customized product range for medical devices and dental implants, pure titanium grades 1,2,3,4, re-melted TiAl6V4, Ti-15Mo, TiA6lNb7

_complete range of hardnesses and grain structures – from work hardened to final annealed

_improved mechanical technological properties through sophisticated process engineering, e.g. with pure titanium to increase fatigue strength

_improved corrosion resistance properties through special Titanium-Molybdenum-Alloys

_Micro structural modification with extra fine grain size to promote special characteristics in the final product _From production and ex-warehouse: tightest tolerances,

above-average straightness characteristics and the highest surface conditions

_outstanding bio-compatibility

IMPLANT MATERIALS MADE OF TITANIUM

norms C Fe O H N Al V Mo Nb Ti

Ergitan®_3.7025MG _{ASTM F67}

ISO 5832-2 min. max. 0.080 0.20 0.18 0.0125 0.03 - - - - bal Ergitan®_3.7035MG _{ASTM F67}

ISO 5832-3 min. max. 0.080 0.25 0.13 0.0120 0.05 5.5 6.5 3.5 4.5 - - bal Ergitan®_9.9150MG _{ASTM F2066}

ISO 5832-14 min. max. 0.100 0.10 0.20 0.0150 0.05 - - 14.0 16.0 - bal Ergitan®_9.9367MG _{ASTM F1295}

ISO 5832-11 min. max. 0.080 0.25 0.20 0.0090 0.05 5.5 6.5 - - 6.5 7.5 bal

(9)

PAGE 9/12 ZAPP MEDICAL ALLOYS | MATERIALS FOR INSTRUMENTS OUTSTANDING QUALITY ADVANTAGES

_greatest possible variety of hardenable and temperable materials to match the broad spectrum of instruments, mainly for use and applications within the ASTM F 899 _increased corrosion resistance of grades with 17

%-chromium content versus grades with 13 %-%-chromium _best corrosion resistance of martensitic grades based

on the combination of precision ground surface and induration process

_optimal machinability with slight loss of corrosion resistance in materials containing sulfur

_from production ex-warehouse, especially for rotating instruments: tightest tolerances, above-average straightness characteristics and highest surface conditions

_special high-tech-grades for surgical needles, bone saws, orthodontic braces, reamer and files, burrs, cutters, and much more

_unique special materials, e.g. garde1.4310FE (re-melted), 1.4034YK (high chromium content), or 1.4028MO(+Mo)

MARTENSITIC GRADES 1.4310 1.4568 1.4542 1.4034 1.4035 +S 1.4197 +S 1.4028 1.4021 1.4125 +S 1.4112 +S 9.9440 1.4057 1.4125 1.4112 1.4122 1.4543 1.4031 +S 1.4123 Corrosion resistance Hard en ab ili ty

13 % Chrome 17 % Chrome Precipitation hardenable austenitic steels

MATERIALS FOR INSTRUMENTS

(10)

PAGE 10/12 ZAPP MEDICAL ALLOYS | MATERIALS FOR INSTRUMENTS - MARTENSITIC

MATERIALS FOR INSTRUMENTS - MARTENSITIC

Brand Name Type ∼ Chemical Composition (Mass-%)

C Si Mn P S Cr Ni Mo Typical Application

Ergste®_1.4021YB _{AISI 420A} _min.

max. 0.16 0.25 1.00 1.00 0.040 0.030 12.00 14.00 1.00 - Instruments, abrasors Ergste®_1.4028YN _{AISI 420B} _min.

max. 0.26 0.35 1.00 1.50 0.040 0.030 12.00 14.00 - - Bone saws, rotating instruments, cutter Ergste®_1.4028MO _{AISI 420B (+Mo) min.}

max. 0.34 0.38 1.00 1.00 0.040 0.030 13.00 14.00 1.00 0.90 1.10 Instruments, abrasors, bone saws Ergste®_1.4031YC _{AISI 420X} _min.

max. 0.36 0.42 1.00 1.00 0.040 0.030 12.50 14.50 - - Surgical needles Ergste®_1.4034YN _{AISI 420C} _min.

max. 0.42 0.50 1.00 1.00 0.040 0.030 12.50 14.50 1.00 - Instrument handholds, abrasors, cutter Ergste®_1.4034YK _{AISI 420C} _min.

max. 0.43 0.50 1.00 1.00 0.040 0.030 13.00 14.50 1.00 - Instrument handholds, abrasors, burrs Ergste®_1.4035YU _{AISI 420C (+S)} _min.

max. 0.43 0.50 1.00 1.00 0.040 0.15 0.30 12.50 14.50 1.00 - Precision instruments, cutter Ergste®_1.4197YU _{AISI 420F mod. min.}

max. 0.20 0.26 1.00 2.00 0.040 0.15 0.27 12.50 14.50 0.75 1.50 1.00 1.50 Dental burrs, dental cutter, surgical needles Ergste®_1.4104YU _{AISI 430F} _min.

max. 0.10 0.17 1.00 1.50 0.040 0.15 0.35 15.50 17.50 - - Instrument handholds Ergste®_1.4057YN _{AISI 431} _min.

max. 0.12 0.22 1.00 1.50 0.040 0.030 15.50 17.00 1.50 2.50 - Medical instruments, cutting tools Ergste®_9.9440YA _{AISI 440A} _min.

max. 0.60 0.75 1.00 1.00 0.040 0.030 16.00 18.00 - 0.75 Dental applications, dental instruments, surgical instruments Ergste®_1.4112YL _{AISI 440B} _min.

max. 0.75 0.95 1.00 1.00 0.040 0.030 17.00 19.00 - 0.95 1.30 Instrument parts, scalpels Ergste®_1.4122YL _min.

max. 0.33 0.45 1.00 1.50 0.040 0.030 15.50 17.50 1.00 0.80 1.30 Chisels, abrasors, cutting instruments Ergste®_1.4123YL

(X15-TN) min. max. 0.35 0.50 1.00 1.00 0.040 0.015 14.00 16.00 0.50 1.00 2.50 Burrs, cutter, reamer, screwdrivers Ergste®_1.4125YL _{AISI 440C} _min.

max. 0.95 1.20 1.00 1.00 0.040 0.030 16.00 18.00 - 0.40 0.80 Surgical instruments, blades

MATERIALS FOR INSTRUMENTS –

MARTENSITIC

(11)

PAGE 11/12 ZAPP MEDICAL ALLOYS | SPECIAL MATERIALS OUTSTANDING QUALITY ADVANTAGES –

PRECIPITATION-HARDENABLE MATERIALS

_The hardenable austenitic steels are characterized by increased corrosion resistance with generally lower hardenability potential versus martensitic steels.

.

PRECIPITAION-HARDENABLE MATERIALS FOR MEDICAL AND DENTAL

Brand Name Type Chemical Composition (Mass-%)

C Si Mn P S Cr Ni Mo Ti Al Cu Nb

Ergste®_1.4310FB

Ergste®_1.4310FE* AISI 301 min. _max. 0.05 _0.15 _1.20 _2.00 _0.045 _0.030 16.00 _19.00 8.00 _10.00 - - - - - Ergste®_1.4542GG _{AISI 630}

17-4-PH min. max. 0.07 1.00 1.00 0.040 0.030 17.50 15.00 3.00 5.00 - - - 3.00 5.00 0.15 0.45 Ergste®_1.4568GA _{AISI 631}

17-7-PH min. max. 0.09 1.00 1.00 0.040 0.030 18.00 16.00 6.50 7.75 - - 0.75 1.50 - - Ergste®_1.4543GG

(Alloy 455) XM-16 min. max. 0.03 0.50 0.50 0.015 0.015 12.50 11.00 7.50 9.50 0.50 0.90 1.40 - 1.50 2.50 0.10 0.50

OUTSTANDING QUALITY ADVANTAGES – MATERIALS FOR MEDICAL AND DENTAL

_Derived over many years market analysis and develop-ment work, the advanced properties of these special materials are far superior to those of conventional commercial grades.

SPECIAL MATERIALS FOR MEDICAL AND DENTAL

Brand Name Type Chemical Composition (Mass-%)

C Si Mn P S Cr Ni Mo Typical Application

Ergste®_1.4310FB

Ergste®_1.4310FE* AISI 301 min. _max. 0.05 _0.15 _1.20 _2.00 _0.045 _0.030 16.00 _19.00 8.00 _10.00 - High-strength wire, root canal-_{files, dental instruments} Ergste®_1.4456CA _min.

max. 0.10 1.00 16.00 20.00 0.050 0.050 16.00 20.00 0.20 1.80 2.50 Nickel-free dental wire, surgical needles Ergste®_9.9035 _MP-35-N _min.

max. 0.025 0.15 0.15 0.015 0.01 19.00 21.00 33.00 37.00 9.00 10.50 Orthodontic wire Ergste®_1.4105IU _{AISI 430F} _min.

max. 0.08 1.50 1.50 0.040 0.15 0.35 16.00 18.00 - - Shafts for rotating instruments Ergste®_1.4303SA _{AISI 305(L)} _min.

max. 0.06 1.00 2.00 0.045 0.030 17.00 19.00 11.00 13.00 - Dental applications made by precision strip Ergste®_1.4305UA _{AISI 303} _min.

max. 0.12 1.00 2.00 0.060 0.15 0.35 17.00 19.00 8.00 10.00 0.70 Surgical instruments, dental instruments, parts for braces * re-melted grade

SPECIAL MATERIALS

(12)

PAGE 12/12 ZAPP MEDICAL ALLOYS | ADDRESSES ZAPP MEDICAL ALLOYS

MEDICAL TECHNOLOGY Zapp Medical Alloys GmbH Letmather Straße 69 58239 Schwerte P.O. BOX 17 20 58212 Schwerte Germany Phone +49 2304 79-540 Fax +49 2304 79-482 medicalalloys@zapp.com Zapp (GB) Ltd. 12 Parkway Close Sheffield S9 4WJ U.K. Phone +44 114 278-8822 Fax +44 114 278-8833 medicalalloys-uk@zapp.com Zapp Precision Wire, Inc. 475 International Circle

Summerville, South Carolina 29483 U.S.A.

Phone +1 843 851-0700 Fax +1 843 851-0010 Toll-free +1 888-777-3962 medicalalloys-usa@zapp.com Service Centers | Sales Offices: www.zapp.com

The illustrations, drawings, dimensional and weight data and other information included in this brochure are intended only for the purposes of describing our products and represent non-binding average values. They do not constitute quality data, nor can they be used as the basis for any guarantee of quality or durability. The applications pre-sented serve only as illustrations and can be construed neither as quality data nor as a guarantee in relation to the suitability of the material. This cannot substitute for compre-hensive consultation on the selection of our products and on their use in a specific application. The brochure is not subject to change control.