Changzhou Biomet Medical Devices Co., Ltd.

Registered establishment in Changzhou, Jiangsu, China. 54 device types.

Registry build 21.09.26

Changzhou Biomet Medical Devices Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Template, Plate, Bone and 52 other device types. Its earliest product listing with the FDA dates from 1977.

54device types registered with the FDA
1recall

Registration

FDA registration record for Changzhou Biomet Medical Devices Co., Ltd.
Status Registered
Registration expires 2026
Registration number 3007923096
FEI number 3007923096
Establishment type Contract manufacturer, Manufacturer

Location

Address of Changzhou Biomet Medical Devices Co., Ltd.
City Changzhou
Province Jiangsu
Address No. 235 Chuangxin Road
Postal code 213031
Country China

Group

Changzhou Biomet Medical Devices Co., Ltd. is one of 2 plants registered under Biomet, Inc..

Other plants under Biomet, Inc.
Plant City Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua 74

What It Makes

Device types Changzhou Biomet Medical Devices Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class 2 Trauma Internal Fixation Systems, Depuy AE TK2 HIP Screw System, Fragment Plate System 2012 17
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class 2 Distal Volar Radius Plating Systems, Trauma Internal Fixation Systems, Distal Volar Radius Anatomical Plate System, Distal Radius Volar RIM Plate Standard AND Narrow, Sterile DVR Anatomic Plates Various Configurations) Model (S, 131212001,2, 5-10 2.5MM Threaded AND Smooth Pegs, Model(S 2012 6
Appliance, Fixation, Spinal Interlaminal Class 2 Polaris Spinal System, EBI MAS Spinal TOP Loading Fixation System, Nextgen Altius OCT System, EBI 5.5 Helical Flange Spinal System, 5.5 Helical Flange Spinal System, Polaris Components, Modification TO Altius OCT System 2009 11
Appliance, Fixation, Spinal Intervertebral Body Class 2 Polaris Spinal System, C-TEK Maxan Anterior Cervical Plate System, EBI MAS Spinal TOP Loading Fixation System, EBI 5.5 Helical Flange Spinal System, Maxan Anterior Cervical Plate System, 5.5 Helical Flange Spinal System, Polaris Components 2009 14
Cover, Burr Hole Class 2 Neuro Plating, System, Biomet Microfixation 2014 3
Fastener, Plate, Cranioplasty Class 2 Neuro Plating, System, Biomet Microfixation 2014 3
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Class 2 G7 Freedom AND Offset Liners, Freedom Head, Size 32, Size 4MM & XR 123, Taperloc Complete, Taperloc Complete Microplasty Stem, G7 Acetabular System, G7 Finned Acetabular Shell and 1 more 2012 8
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Class 2 G7 Freedom AND Offset Liners, Freedom Head, Size 32, G7 Acetabular System, G7 Finned Acetabular Shell 2013 5
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class 2 G7 Freedom AND Offset Liners, Freedom Head, Size 32, G7 Acetabular System, G7 Finned Acetabular Shell 2013 5
Implant, Endosseous, Root-Form Class 2 Lorenz, IMF Screw, Self-Drilling 2014 7
Nail, Fixation, Bone Class 2 Affixus Tibial Nailing System 2016 3
Orthosis, Spinal Pedicle Fixation Class 2 Polaris Spinal System, EBI MAS Spinal TOP Loading Fixation System, Nextgen Altius OCT System, EBI 5.5 Helical Flange Spinal System, 5.5 Helical Flange Spinal System, Polaris Components 2009 13
Orthosis, Spondylolisthesis Spinal Fixation Class 2 Polaris Spinal System, EBI MAS Spinal TOP Loading Fixation System, Nextgen Altius OCT System, EBI 5.5 Helical Flange Spinal System, 5.5 Helical Flange Spinal System, Polaris Components 2009 13
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Class 2 Polaris Spinal System 2016 7
Pin, Fixation, Smooth Class 2 Trauma Internal Fixation Systems 2012 12
Pin, Fixation, Threaded Class 2 Trauma Internal Fixation Systems 2012 9
Plate, Bone Class 2 Biomet Microfixation OmniMax MMF System, 1.5MM, 2MM System, Lorenz 1MM,, System (Traumaone), Fracture/Reconstruction, Facial Plating System and 5 more 2014 3
Plate, Cranioplasty, Preformed, Alterable Class 2 Neuro Plating, System, Biomet Microfixation 2014 2
Plate, Cranioplasty, Preformed, Non-Alterable Class 2 Spin Down Rapidflap 2009 3
Plate, Fixation, Bone Class 2 Trauma Internal Fixation Systems, Anterolateral AND Medial Locking Plating System, A.l.p.s. Calcaneal Plating System, Profile AND Multidirectional Screws, Proximal Tibia Locking Plate Standard AND Large, 3.5MM LOW, Biomet Microfixation RibFix Blu Thoracic Fixation System and 39 more 2012 22
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Class 2 Altra Press-FIT HIP System, Taperloc® Complete Hip Stems, Taperloc Complete, Size 5 AND 6, Taperloc Complete Hip Stem, Taperloc Complete, Altra FX HIP System 2008 7
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class 2 Altra Press-FIT HIP System, G7 Freedom AND Offset Liners, Freedom Head, Size 32, Z1 Cemented Hip System, Size 4MM & XR 123, Taperloc Complete, Taperloc Complete Microplasty Stem and 6 more 2008 10
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Class 2 G7 Freedom AND Offset Liners, Freedom Head, Size 32, G7 Acetabular System, G7 Finned Acetabular Shell 2013 5
Prosthesis, Hip, Femoral Component, Cemented, Metal Class 2 Integral Co-CR Femoral Component 2008 5
Prosthesis, Hip, Hemi-, Femoral, Metal Class 2 Altra Press-FIT HIP System, Z1 Cemented Hip System, Size 4MM & XR 123, Taperloc Complete, Taperloc Complete Microplasty Stem, Taperloc® Complete Hip Stems and 3 more 2008 10
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class 2 Altra Press-FIT HIP System, Z1 Cemented Hip System, Bipolar HIP Device, Size 4MM & XR 123, Taperloc Complete, Taperloc Complete Microplasty Stem and 6 more 2008 14
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Class 3 Altra Press-FIT HIP System, Taperloc Complete Microplasty Stem, Taperloc Complete, Size 5 AND 6, Taperloc Complete, Altra FX HIP System 2008 4
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class 3 Altra Press-FIT HIP System, Taperloc Complete Microplasty Stem, Taperloc Complete, Size 5 AND 6, Taperloc Complete, Contraindications, Biomet Metal-ON-Metal HIP Systems- Expanded and 1 more 2008 4
Prosthesis, Hip, Semi-Constrained, Composite/Metal Class 2 Mallory/Head Total HIP System 2012 3
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 Altra Press-FIT HIP System, G7 Freedom AND Offset Liners, Freedom Head, Size 32, Z1 Cemented Hip System, Integral Co-CR Femoral Component, Size 4MM & XR 123, Taperloc Complete and 11 more 2008 15
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Class 2 Altra Press-FIT HIP System, G7 Freedom AND Offset Liners, Freedom Head, Size 32, Ringloc 36MM Line AND Modular Femoral Heads, Modular Protusio CUP, Salvage/Onocology HIP AND Total Femur System, Mallory-Head Modular Calcar Repacement Components and 15 more 2008 13
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class 2 Altra Press-FIT HIP System, G7 Freedom AND Offset Liners, Freedom Head, Size 32, Ringloc 36MM Line AND Modular Femoral Heads, Titanium LOW Profile Screws, Trilogy Acetabular System, Size 4MM & XR 123 and 15 more 2008 14
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Class 2 Altra Press-FIT HIP System, Z1 Cemented Hip System, Taperloc Complete, Size 5 AND 6, Taperloc Complete, Altra FX HIP System 2008 9
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class 2 Altra Press-FIT HIP System, Z1 Cemented Hip System, Size 4MM & XR 123, Taperloc Complete, Taperloc Complete Microplasty Stem, Ringloc BI-Polar Acetabular Component and 4 more 2008 14
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Class 2 Salvage/Onocology HIP AND Total Femur System, Zimmer Knee Joint Replacement Prostheses MR Labeling 2008 7
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class 2 Biomet Knee Joint Replacement Prostheses 2017 10
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Class 3 Oxford Meniscal Unicom 2006 3
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class 2 Zimmer Knee Joint Replacement Prostheses MR Labeling 2019 7
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Class 2 Vanguard 360 Revision Knee System, Vanguard XP Knee System, Biomet Knee Joint Replacement Prostheses, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Offset Tibial Tray 2011 5
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class 2 AGC Total Knee System Knee, Ascent Total Knee System, Maxim, Complete Knee System, Maxim Accel Knee System Also Known, Vanguard XP Knee System, Biomet Knee Joint Replacement Prostheses, Zimmer Knee Joint Replacement Prostheses MR Labeling, Zimmer Persona Personalized Knee System and 2 more 2008 12
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Class 2 Vanguard XP Knee System, Biomet Knee Joint Replacement Prostheses, Zimmer Persona Personalized Knee System, Vanguard Complete Knee System 2012 8
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class 2 Vanguard 360 Revision Knee System, NexGen Legacy PS (L-PS), NexGen Legacy CCK (L-CCK), Next Generation Knee System, Molded Poly Tibia, Vanguard Removable and 10 more 2008 21
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Class 2 Versa-Dial Humeral Head Prosthesis, Comprehensive Shoulder System, Versa-Dial Humeral Head 2008 8
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 Versa-Dial Humeral Head Prosthesis, Comprehensive Shoulder System, Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Versa-Dial Humeral Head 2008 6
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Class 2 Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate 2018 2
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 Versa-Dial Humeral Head Prosthesis, Comprehensive Reverse Shoulder, Comprehensive Reverse Shoulder-Mini Baseplate, Comprehensive Shoulder System, Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Versa-Dial Humeral Head 2008 9
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 Versa-Dial Humeral Head Prosthesis, Comprehensive Shoulder System, Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Versa-Dial Humeral Head 2008 5
Rod, Fixation, Intramedullary And Accessories Class 2 Trauma Internal Fixation Systems, Zindrick IM ROD, Affixus Tibial Nailing System, Affixus Tibial and Antegrade Femoral Nailing System 2012 17
Screw, Fixation, Bone Class 2 Trauma Internal Fixation Systems, Profile AND Multidirectional Screws, Proximal Tibia Locking Plate Standard AND Large, 3.5MM LOW, Biomet Microfixation RibFix Blu Thoracic Fixation System, 131211130, 1.5 MM Locking Screws, Models 131220408-131220424, 2.5 MM Multidirectional Threaded Pegs, Models 131211110- and 24 more 2012 31
Screw, Fixation, Intraosseous Class 2 Biomet Microfixation OmniMax MMF System, Lorenz IMF Screw 2014 3
Shoulder Prosthesis, Reverse Configuration Class 2 Comprehensive Reverse Shoulder, Comprehensive Reverse Shoulder-Mini Baseplate, Comprehensive Vault Reconstruction System, Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate 2009 9
Template Class 1 Biomet Template 1977 21
Thoracolumbosacral Pedicle Screw System Class 2 Polaris Spinal System, EBI MAS Spinal TOP Loading Fixation System, EBI 5.5 Helical Flange Spinal System, 5.5 Helical Flange Spinal System, Polaris Components 2009 15
Washer, Bolt Nut Class 2 Trauma Internal Fixation Systems, Olecranon Plates Model 131218704-708; 851318704-708, 1312182, Medical Plates, Lateral Plates, Posterior Lateral Plates,, Anatomic Locking Plating System 2012 9

Clearances

No clearance names Changzhou Biomet Medical Devices Co., Ltd. as applicant. 81 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Changzhou Biomet Medical Devices Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K251270 2026-05-19 LPH Traditional Biomet, Inc.
K202232 2021-02-19 PHX Traditional Biomet Manufacturing Corp
K200196 2020-12-08 LZO Traditional Biomet Orthopedics
K193038 2020-10-28 MBF Traditional Biomet Manufacturing Corp
K193373 2020-04-15 PHX Traditional Biomet, Inc.
K173767 2018-04-06 HRS Traditional Biomet, Inc.
K172502 2018-01-03 PHX Traditional Biomet Manufacturing Corp
K171054 2017-07-28 JWH Traditional Biomet, Inc.
K150867 2015-06-10 HSB Traditional Biomet, Inc.
K143697 2015-03-30 HRS Traditional Biomet Manufacturing Corp
K142882 2015-02-10 LPH Traditional Biomet, Inc.
K142746 2014-12-29 LPH Traditional Biomet Manufactuting Corp.
K142933 2014-12-23 JWH Traditional Biomet, Inc.
K140622 2014-05-13 HRS Traditional Biomet, Inc.
K133939 2014-04-01 HRS Traditional Biomet, Inc.
K132873 2013-12-11 MBH Traditional Biomet, Inc.
K132898 2013-11-19 HRS Traditional Biomet Manufacturing Corp
K131867 2013-10-29 HRS Traditional Biomet, Inc.
K132704 2013-10-09 LXT Traditional Biomet, Inc.
K131670 2013-07-03 HRS Traditional Biomet, Inc.
K121874 2012-11-23 PBI Traditional Biomet Manufacturing Corp
K120030 2012-08-17 LPH Traditional Biomet Manufacturing Corp
K113550 2012-02-29 JWH Traditional Biomet Manufacturing Corp
K120121 2012-02-16 PHX Special Biomet, Inc.
K110400 2011-09-30 KWA Traditional Biomet Manufacturing Corp
K102580 2011-03-03 JWH Traditional Biomet Manufacturing Corp
K103755 2011-01-21 KWA Special Biomet Manufacturing Corp
K103408 2010-12-16 HRS Special Depuy Orthopaedics, Inc.
K093293 2010-10-22 JWH Traditional Biomet, Inc.
K101086 2010-09-03 KWA Traditional Biomet, Inc.
K101421 2010-06-15 HRS Special Depuy Orthopaedics, Inc.
K091294 2009-07-24 HRS Traditional Depuy Orthopaedics, Inc.
K090877 2009-06-26 HRS Traditional Depuy Orthopaedics, Inc.
K083843 2009-03-20 HRS Traditional Depuy Orthopaedics, Inc.
K082300 2009-02-18 HRS Traditional Depuy Orthopaedics, Inc.
K082446 2008-10-15 KWA Traditional Biomet, Inc.
K080642 2008-07-09 PHX Traditional Biomet, Inc.
K072832 2007-12-14 HRS Traditional Depuy Orthopaedics, Inc.
K072083 2007-10-25 HRS Traditional Depuy Orthopaedics, Inc.
K063614 2007-02-20 KWA Traditional Biomet Manufacturing Corp
K063732 2007-01-18 JWH Traditional Biomet Manufacturing Corp
K063002 2006-10-31 KWA Special Biomet Manufacturing Corp
K060716 2006-06-12 MBF Traditional Biomet Manufacturing Corp
K051569 2005-09-29 JDI Traditional Biomet, Inc.
K040610 2004-06-04 KWS Traditional Biomet Manufacturing Corp
K033489 2004-06-02 MBH Traditional Biomet, Inc.
K032396 2003-08-21 JDI Special Biomet, Inc.
K023546 2003-01-17 JWH Traditional Biomet, Inc.
K023357 2002-11-06 LPH Special Biomet Orthopedics
K010212 2001-02-14 MBV Special Biomet, Inc.
K990830 2000-04-11 LPH Traditional Biomet, Inc.
K991807 1999-07-08 LPH Traditional Biomet, Inc.
K990032 1999-02-18 JDI Traditional Biomet, Inc.
K984408 1999-02-12 LPH Traditional Biomet, Inc.
K984154 1999-02-11 JDI Traditional Biomet, Inc.
K984028 1999-01-19 KWL Traditional Biomet, Inc.
K983710 1998-12-02 JDI Traditional Biomet, Inc.
K974558 1998-03-04 JDI Traditional Biomet, Inc.
K972629 1997-10-09 KTT Traditional Depuy Intl., Ltd.
K971890 1997-08-07 JDI Traditional Biomet, Inc.
K960303 1996-06-21 LPH Traditional Biomet, Inc.
K955350 1996-02-16 LZO Traditional Biomet, Inc.
K953925 1996-01-31 LZO Traditional Biomet, Inc.
K954485 1995-10-31 HWC Traditional ACE Medical
K950618 1995-05-10 HRS Traditional ACE Medical
K945115 1995-05-02 JDI Traditional Biomet, Inc.
K942479 1994-09-20 JDG Traditional Biomet, Inc.
K921301 1994-02-16 LPH Traditional Biomet, Inc.
K926047 1993-03-31 HWC Traditional Ace Orthopedic Manufacturing Co.
K915132 1992-02-11 JWH Traditional Biomet, Inc.
K912245 1991-08-19 JWH Traditional Biomet, Inc.
K911684 1991-06-27 JDI Traditional Biomet, Inc.
K905048 1991-01-30 HWC Traditional ACE Medical
K903810 1990-10-16 HWC Traditional ACE Medical
K903811 1990-10-16 HWC Traditional ACE Medical
K882831 1988-08-01 HWC Traditional Buckman Co., Inc.
K874670 1987-12-17 HWC Traditional Buckman Co., Inc.
K871539 1987-08-17 HSB Traditional Buckman Co., Inc.
K872859 1987-08-17 HWC Traditional ACE Medical
K853259 1985-11-01 KMC Traditional Biomet, Inc.
K833175 1983-12-22 KWY Traditional Biomet, Inc.

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming Changzhou Biomet Medical Devices Co., Ltd.
Initiated FDA class Root cause Reason Closed
2022-06-02 Class II Process control One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates 2024-02-12

PMA Approvals

A premarket approval is the Class III route: granted on clinical evidence, not on equivalence to a device already on the market.

FDA premarket approvals naming Changzhou Biomet Medical Devices Co., Ltd. or its listings
PMA number Decision Trade name Product code Held by
P010014 2018-04-19 Oxford Patrial Knee System NRA Biomet Manufacturing Corp

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
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Stryker Trauson (Changzhou) Medical Technology Co., Ltd. 3
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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer