Data / Medical devices / China / Changzhou Biomet Medical Devices Co., Ltd.
Changzhou Biomet Medical Devices Co., Ltd.: FDA-registered device maker in Changzhou City Jiangsu, China, 88 510(k) clearances and 1 PMA approval
Changzhou Biomet Medical Devices Co., Ltd. is registered with the FDA (registration 3007923096) in Changzhou City Jiangsu, China. It lists 48 device types. The FDA files 88 510(k) clearances and 1 PMA approval under its listings, the newest dated May 19, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007923096
- Address
- No. 235 Chuangxin Road EPZ Xinbei District, Changzhou City Jiangsu, China, 213031
- Owner or operator
- Zimmer Inc (1825034)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 28, 1977
- Registered through
- 2027
- Brand names listed
- & BONE SCREWS, 1.5MM, 2MM SYSTEM, 130 MODIFIED INTEGRAL FEMORAL COMPONENT, 131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424, 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S, 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH, 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-, 2.5MM INLINE FUSION PLATE and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 19, 2026 | K251270 | Taperloc® Complete Hip Stem | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 19, 2021 | K202232 | Comprehensive Vault Reconstruction System | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 8, 2020 | K200196 | Taperloc® Complete Hip Stems | LZO | Substantially Equivalent | Biomet Orthopedics | accessdata.fda.gov |
| October 28, 2020 | K193038 | Comprehensive Shoulder System | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| April 15, 2020 | K193373 | Comprehensive® Reverse Shoulder | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 6, 2018 | K173767 | A. L. P. S. Clavicle Plating System | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 3, 2018 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | PHX | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| July 28, 2017 | K171054 | Biomet Knee Joint Replacement Prostheses | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 10, 2015 | K150867 | Affixus Tibial Nailing System | HSB | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 30, 2015 | K143697 | Biomet Proximal Humerus Plating System | HRS | Substantially Equivalent | Biomet Manufacturing | accessdata.fda.gov |
| February 10, 2015 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 29, 2014 | K142746 | G7 Finned Acetabular Shell | LPH | Substantially Equivalent | Biomet Manufactuting Corp. | accessdata.fda.gov |
| December 23, 2014 | K142933 | Biomet Tibial trays | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 13, 2014 | K140622 | DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 1, 2014 | K133939 | MODIFIED DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | Biomet | accessdata.fda.gov |
| December 11, 2013 | K132873 | VANGUARD XP KNEE SYSTEM | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 19, 2013 | K132898 | A.L.P.S. CALCANEAL PLATING SYSTEM | HRS | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 29, 2013 | K131867 | 2.5MM INLINE FUSION PLATE | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 9, 2013 | K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | LXT | Substantially Equivalent | Biomet | accessdata.fda.gov |
| July 3, 2013 | K131670 | LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) | HRS | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 23, 2012 | K121874 | G7 ACETABULAR SYSTEM | PBI | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| August 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 12, 2012 | K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 29, 2012 | K113550 | VANGUARD COMPLETE KNEE SYSTEM | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| February 16, 2012 | K120121 | COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 31, 2011 | K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | LXT | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
| September 30, 2011 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 3, 2011 | K102580 | VANGUARD REMOVABLE MOLDED POLY TIBIA | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 21, 2011 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| December 16, 2010 | K103408 | POSTERIOR LATERAL PLATES | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 22, 2010 | K093293 | VANGUARD 360 REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 3, 2010 | K101086 | TAPERLOC COMPLETE | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 23, 2010 | K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 15, 2010 | K101421 | MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 24, 2009 | K091294 | LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 26, 2009 | K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 20, 2009 | K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 11, 2009 | K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | LXT | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 18, 2009 | K082300 | ANATOMIC LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 11, 2008 | K083364 | 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 15, 2008 | K082446 | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 26, 2008 | K081546 | SMALL BONE LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 9, 2008 | K080642 | COMPREHENSIVE REVERSE SHOULDER | PHX | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 14, 2007 | K072832 | ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 25, 2007 | K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 20, 2007 | K063614 | ALTRA FX HIP SYSTEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 18, 2007 | K063732 | MICROPLASTY TIBIAL TRAYS | JWH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 31, 2006 | K063002 | ALTRA PRESS-FIT HIP SYSTEM | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| June 12, 2006 | K060716 | VERSA-DIAL HUMERAL HEAD PROSTHESIS | MBF | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| September 29, 2005 | K051569 | RINGLOC BI-POLAR ACETABULAR COMPONENT | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 14, 2005 | K052248 | DORSAL NAIL PLATE, ANATOMICAL | HRS | Substantially Equivalent | Hand Innovations, LLC | accessdata.fda.gov |
| April 26, 2005 | K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | LXT | Substantially Equivalent | Hand Innovations, Inc. | accessdata.fda.gov |
| June 4, 2004 | K040610 | VERSA-DIAL HUMERAL HEAD | KWS | Substantially Equivalent | Biomet Manufacturing, Inc. | accessdata.fda.gov |
| June 2, 2004 | K033489 | AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 21, 2003 | K032396 | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 17, 2003 | K023546 | MAXIM ACCEL KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 6, 2002 | K023357 | ARCPM 1050 RESIN-HIPS | LPH | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| February 14, 2001 | K010212 | OFFSET TIBIAL TRAY | MBV | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| April 11, 2000 | K990830 | MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 8, 1999 | K991807 | TITANIUM LOW PROFILE SCREWS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 18, 1999 | K990032 | MODULAR PROTUSIO CUP | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 12, 1999 | K984408 | 130 MODIFIED INTEGRAL FEMORAL COMPONENT | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 19, 1999 | K984028 | THE NEW BIO-MOORE ENDO HEADS | KWL | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 2, 1998 | K983710 | 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 4, 1998 | K974558 | SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 9, 1997 | K972629 | DEPUY AE TK2 HIP SCREW SYSTEM | KTT | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| August 7, 1997 | K971890 | RECOVERY PROTRUSIO CAGE | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 21, 1996 | K960303 | FENNING FEMORAL COMPONENT | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| January 31, 1996 | K953925 | FINE GRAIN CAST COBALT CHROMIUM HIP STEMS | LZO | Substantially Equivalent for Some Indications | Biomet, Inc. | accessdata.fda.gov |
| October 31, 1995 | K954485 | 6.5MM SOLID CANCELLOUS BONE SCREW | HWC | Substantially Equivalent | Ace Medical Co. | accessdata.fda.gov |
| May 10, 1995 | K950618 | ACE SUPRACONDYLAR PLATE | HRS | Substantially Equivalent | Ace Medical Co. | accessdata.fda.gov |
| May 2, 1995 | K945115 | MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS | JDI | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 20, 1994 | K942479 | INTEGRAL CO-CR FEMORAL COMPONENT | JDG | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 16, 1994 | K921301 | TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 31, 1993 | K926047 | ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW | HWC | Substantially Equivalent | Ace Orthopedic Manufacturing Co. | accessdata.fda.gov |
| February 11, 1992 | K915132 | MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 19, 1991 | K912245 | AGC REVISION KNEE PROTHESIS | JWH | Substantially Equivalent for Some Indications | Biomet, Inc. | accessdata.fda.gov |
| June 27, 1991 | K911684 | BIOMET COBALT-CHROME FEMORAL COMPONENTS | JDI | Substantially Equivalent for Some Indications | Biomet, Inc. | accessdata.fda.gov |
| January 30, 1991 | K905048 | ACE 3.5MM CORTICAL BONE SCREW | HWC | Substantially Equivalent | Ace Medical Co. | accessdata.fda.gov |
| October 16, 1990 | K903811 | ACE CANNULATED CORTICAL BONE SCREW | HWC | Substantially Equivalent for Some Indications | Ace Medical Co. | accessdata.fda.gov |
| October 16, 1990 | K903810 | ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW | HWC | Substantially Equivalent for Some Indications | Ace Medical Co. | accessdata.fda.gov |
| August 1, 1988 | K882831 | ACE CANCELLOUS BONE SCREW | HWC | Substantially Equivalent | Buckman Co., Inc. | accessdata.fda.gov |
| December 17, 1987 | K874670 | ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW | HWC | Substantially Equivalent | Buckman Co., Inc. | accessdata.fda.gov |
| December 11, 1987 | K874672 | ACE CORTICAL LAG SCREW | HWC | Substantially Equivalent | Buckman Co., Inc. | accessdata.fda.gov |
| August 17, 1987 | K872859 | ACE CANCELLOUS BONE SCREW | HWC | Substantially Equivalent | Ace Medical Co. | accessdata.fda.gov |
| August 17, 1987 | K871539 | ZINDRICK IM ROD | HSB | Substantially Equivalent | Buckman Co., Inc. | accessdata.fda.gov |
| November 1, 1985 | K853259 | MALLORY/HEAD TOTAL HIP SYSTEM | KMC | Substantially Equivalent for Some Indications | Biomet, Inc. | accessdata.fda.gov |
| December 22, 1983 | K833175 | BIOMET BIPOLAR PROSTHESIS | KWY | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 21, 2004 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 107 | October 6, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 2, 2022 | 90421 | Class II | Terminated | DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius. | One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Updated October 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.