CANNULATED ROUND BARS IN STAINLESS STEELS AND TITANIUM ALLOYS FOR SURGICAL TOOLS AND IMPLANTS. Main Catalog

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1 CANNULATED ROUND BARS IN STAINLESS STEELS AND TITANIUM ALLOYS FOR SURGICAL TOOLS AND IMPLANTS Main Catalog - Introduction - A 1 Alloys selection for medical instruments - A 3 Grade 420 B cannulated bars - A 4 Grade 630 cannulated bars - A 6 Grade X15TN cannulated bars - A 7 Grade 455 cannulated bars - A 8 Grade 465 cannulated bars - B 1 Alloy selection for medical implants - B 3 Grade 316 L implant cannulated bars - B 4 Grade Ti6Al4VELI cannulated bars - FAI Specifications - FAI Concentricity diagram Bold and red fonts: GRADES AVAILBLE FROM U.S. All the information given in this document has been checked carefully at the time of publication, but is released under reserve of printing errors. The information may be modified in the course of time without prior notice. Only information taken from our formal proposal and certificates is considered binding. Version non-contractual document

2 FORECREU Biometal Our products Forécreu Biometal designs, manufactures and markets cannulated bars in stainless steels, special steels and titanium for the manufacture of: - medical tools - medical implants - and dental tools Stainless steels cannulated bars for the manufacture of: - Drills, taps, reamers, screw-drivers, drilling guides, bushings. - Dental end mills, ancillary, and many other tools. Implant grade quality stainless steels and titanium alloys cannulated bars for the manufacture of: - Cannulated screws, intramedullary nails, and many other osteo synthesis implants. Our Customers Small and medium-sized companies or large international groups they are specialized in the manufacture of medical, surgical and dental tools and implants such as orthopaedic implants and screws for the Osteosynthesis and trauma products. Our industrial partners Among Forécreu s privileged partners are Aubert & Duval for stainless steels and special alloys and Timet for titanium alloys, with which it operates on a close basis of industrial, technical and commercial cooperation (Nickel-free stainless steel, nitrogen-enriched martensitic stainless steel, Beta Titanium, ). Forécreu also maintains close relations with other leading participants in their respective fields (Erasteel, Böhler and Cartech). Finally, the Forécreu Group works with other partners as part of its research and development program (ASTM, Government R&D Partners, Public Institutes, and Materials Forum). Our sales network Our products are marketed on all five continents. Forécreu also enjoys strong commercial presence: In France, Germany, Italy through subsidiaries or sales offices. In the United States and Japan: local subsidiaries with inventory. In Brazil, China and India and other countries: through local or direct agents. The rest of the world market is served from our company head office in Commentry (center of France). Since its founding, Forécreu has maintained strong export activities. All our international addresses are available on our Internet site at: under CONTACT. Our processes Our main industrial sites are in the Allier region (central France) and handle most operations from design to finish. grinding,). Our industrial experience includes forging, rolling, extrusion, hot and cold processing (drawing) as well as many finishing or product customization operations (cutting, The quality of our processes goes hand in hand with controls (suppliers audit, ultrasonic control, metallurgical testing in workshop and laboratory, mechanical tests). It is covered by ISO 9001 certification and meets the requirements of standard ISO Version non-contractual document

3 Y X 60 Ø120 Ø Other divisions VBM Orthopaedic polymers Injection molding of orthopaedic Polymers such as PLLA, PMMA, and PEEK for use as implants (spinal, fixation, trauma, spacers plug, and plates) VBM operates as wholly-owned affiliated company. Our services: Our experience of more than 55 years, combined with our international presence, enables us to serve and develop markets by: Short lead times, Flexibility in adaptation to the specific needs of our markets and customers, TOOLING Customized technical assistance from selection to product implementation. HIGH SPEED STEEL AND SPECIAL STEEL STRAIGHT AND TWISTED HOLLOW ROUND BARS High speed steel and special steel straight and twisted hollow round bars for the manufacture of coolant fed cutting tools. (Drills, taps, reamers) Setting up of information services available on the Internet with online consulting of world inventories, catalogues and technical documentation. Direct global access to a single address: FOR THE MANUFACTURE OF COOLANT FED CUTTING TOOLS Ø39.22 HOLLOWTECH Research & Development Partnership for specific needs (application to new alloys, new grades, particular geometries, etc CD Ø13.5 à Ø13.5 à 30 Ø78.43 Hollow bars with one or several holes for industrial applications (components, high pressure, nuclear, aeronautics, plastic moulding). Hollow bars with one or several holes for industrial applications Version non-contractual document

4 For medical instruments AFNOR AISI EN/DIN/NF STAINLESS STEELS WERKSTOFF NR. TRADE MARK 1) Austenitic type Z2CND L X2CrNiMo M25W STANDARDS ISO D ASTM F-138-G2 2) Martensitic Z30C13 Z65CDV17 Z90CDV18 420B 440A (440B) X33Cr13 X65CrMo17 X90CrMoV X13 CARTECH NF ISO ASTM F-899 BS 420S45 NF (ASTM F-899) Z40CDV16.02+Az ~ 420(X) X2CrNiTiMo12.12 X40CrMoVN Custom465 X15TN UNS: S46500 UNS S ) Age and precipitation hardening type Z3CNUTNb12-9 Z6CNU17-04 XM X3CrNiCuTiNb X5CrNiCuNb TITANIUM ALLOYS CarTech 455 M X455 X17U4 DU3 17-4PH UNS S45500 ASTM F-899 NF NF ASTM F-899 AMS A-564 4) Vanadium titanium alloy TA6VELI Ti6Al4VELI /5 ISO ASTM F-136 GRADES 1) Austenitic type stainless steel 2) Martensitic type stainless steel 3) Age and precipitation hardening type stainless steels 4) High strength titanium alloys Tool and instruments parts, drill guides, bushings, impactors. Drills, taps, reamers, end mills, dental tools. Hexagon, cross shaped screwdrivers, drill guides and bushings. Medical and dental tooling Version non-contractual document

5 In stainless steel for Medical tools and Instruments Z33C13 AISI 420B X33Cr13 GRADE General purpose 13% chromium martensitic stainless steel. It is supplied in the annealed, (max.235 HB) condition. Its optimal hardness/corrosion resistance level at 52 HRC is obtained by hardening at 1045 C and tempering at around 200 C. To reach the highest corrosion and resistant level, do not exceed a 420 C tempering temperature. Surface polishing considerable improves its corrosion resistance. Drills, end mills, taps, reamers and other medical tools Feasible and available in the U.S. upon special request Sizes: O.D IN FRACTIONAL 1/8 3/16 ¼ 5/16 3/8 ½ 5/8 21/32 I.D IN DECIMAL

6 In stainless steel For medical tools and Instruments Z6CNU1704 AISI 630 X5CrNiCuNb X17U4 /DU3 GRADE Precipitation hardening martensitic stainless steel. It is delivered in solution annealed (max. (350HB). Age hardening at 500 C gives it a high mechanical strength and hardness (44 HRc) together with an excellent corrosion resistance. Medical tools, instrument parts, drill guides, screwdrivers and Small diameter drills. Bold and red available in the U.S. other available upon special request Sizes: O.D IN FRACTIONAL 1/8 3/16 ¼ 5/16 3/8 ½ 5/8 21/32 I.D IN DECIMAL

7 In stainless steel for medical Tools and Instruments X15TN X40CrMoVN 16.2 EN GRADE Martensitic stainless steel exhibiting an outstanding combination of corrosion resistance, wear resistance, hardness and high cutting properties. Maximum hardness of 56/57 HRC can be obtained by austenitization at 1010 C and tempering at 180 C. For some applications, the hardness can be optimised to 58/59 HRC without reducing corrosion resistance, by increasing austenitization temperature to 1050 C with tempering done at 180 C. A cryogenic treatment 75/-80 C must be done between austenitization and tempering. Drill bits, reamers, end mills, drivers, Bushings. Feasible and available in the U.S. upon special request Size : O.D IN FRACTIONAL 1/8 3/16 ¼ 5/16 3/8 ½ 5/8 21/32 I.D IN DECIMAL

8 In stainless steel For medical tools and Instruments Z3CNUTNb12-9 AISI XM16 X3CrNiCuTiNb Mix 455 Cartech GRADE Age hardening martensitic stainless steel with a high hardness and exceptional mechanical strength. Supplied in solution annealed «condition A». Age hardening takes place at 480 C for 4 hours, to achieve 47 HRc. This alloy is particularly recommended for hexagon and cross-shaped screw drivers and for long, small section instruments requiring maximum torque strength. Hexagon and cross-shaped screw drivers, Torque, and any small section instruments. Bold and red available in the U.S., other available upon special request Sizes: O.D IN FRACTIONAL 1/8 3/16 ¼ 5/16 3/8 ½ 5/8 21/32 I.D IN DECIMAL

9 In stainless steel For medical tools and Instruments UNS: S46500 X2CrNiTiMo12.12 Custom 465 GRADE Age hardening martensitic stainless steel with a high hardness and corrosion resistance and exceptional mechanical strength. Supplied in solution annealed «condition A». Hexagon and cross-shaped screw drivers, Torque and any small section instruments. The new grade offers corrosion resistance approaching that provided by Type 304 stainless steel. This alloy is designed for applications needing the best combination of strength, toughness and stress corrosion cracking resistance. UTS could reach 260Ksi / 1790 MPa, equivalent to HRc if aging treatment is applied after cold working. Bold and red available in the U.S., other available upon special request Sizes: O.D IN FRACTIONAL 1/8 3/16 ¼ 5/16 3/8 ½ 5/8 21/32 I.D IN DECIMAL

10 For medical implants B1 AISI DIN WERKS TOFFNR. TRADEMARK STANDARDS 1) General purposes 316 L X2CrNiMo Biodur 316LS M25W ISO D ASTM F-138 2) Nickel- free (R&D project) 3) Vanadium titanium alloy - X8MnCrMoN Ti6AI4VELI /5 TAV - nonicm2 CarTech Biodur 108 ASTM F2229 TM ISO ASTM F136 4) Niobium TM ISO titanium alloy Ti6Al7Nb - - TAN ASTM F-1295 GRADES 1) General purpose austenitic stainless steel 2) High strength nitrogen enriched austenitic stainless steel 3) Nickel-free stainless steels 4) Vanadium titanium alloy Screws for osteosynthesis, malleolar, Hips, condylar, ethmoid, spinal. Various screws, hips and intramedullary nails Permanent Implants, spinal, pedicle and Trauma screws, screws for osteosynthesis & Intramedullary nails 5) Niobium titanium alloy B1

11 In stainless steel For medical implants. B3 Z2CND AISI 316L implant X2CrNiMo M25W GRADE Re-melted implant quality stainless steel melting ISO D, ASTM F-138 G-2, BS D, DIN with minimum 125 KSI or 860 N/mm 2 Ultimate Tensile Strength. Compression hip screws, lag screws, Small fragments screws and intramedullary Nails. Bold and red available in the U.S. other available upon special request Sizes: O.D IN FRACTIONAL I.D IN DECIMAL 11/64 3/16 ¼ 5/16 3/8 ½ B3

12 B4 In titanium alloys For medical implants TA6VELI Ti6Al4VELI W. Nr /5 GRADE Alpha-beta equiaxial vanadium/titanium alloy meets ASTM F-136 and ISO This highly biocompatible alloy shows extremely high mechanical strength (minimum 125 KSI 860 N/mm 2 Ultimate Tensile Strength) combined with excellent corrosion resistance. Compression hip screws, lag screws, Small fragment screws and Intramedullary nails, spinals, Interference screws. Bold and red available in the U.S. other available upon special request Sizes: O.D IN FRACTIONAL 11/64 3/16 7/32 ¼ 5/16 3/8 7/16 ½ I.D IN DECIMAL B4

13 Standard Specifications for Biomedical cannulated bars. Unless otherwise specified and agreed, these specifications are Guaranteed by Process Grade Titanium (Ti6Al4Veli-Ti6Al7Nb)-ASTM F 136-F L ASTM F , 455 ASTM F B, 440A ASTM F 899 Specifications O.D. Tolerance: +/ O.D surface finish: RMS 32 Conversion rate Mpa/ ksi: 1 Mpa = ksi 160 ksi = 1103 Mpa I.D. Tolerance: +/- 5% of I.D nominal. o Value checked by pin gauging both ends (Tol +0 / ) I.D Crack Size: Concentricity: to % of O.D. See diagram. T.I.R: 2X Concentricity. Bar length: 8-12 feet. Straightness: / Ft.

14 CONCENTRICITY DIAGRAM FOR MEDICAL GRADE O.D. = I.D = E O.D X 1.6 % T.I.R= 2 E E X 1.6%= T.I.R

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