Data / Medical devices / United States / Zimmer Trabecular Metal Technology, Inc.
Zimmer Trabecular Metal Technology, Inc.: FDA-registered device maker in Parsippany, NJ, United States, 32 510(k) clearances
Zimmer Trabecular Metal Technology, Inc. is registered with the FDA (registration 3005751028) in Parsippany, NJ, United States. It lists 47 device types. The FDA files 32 510(k) clearances under its listings, the newest dated March 29, 2023. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3005751028
- Address
- 10 Pomeroy RD., Parsippany, NJ, United States, 07054
- Owner or operator
- ZIMMER, INC. (1822565)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- May 20, 1999
- Registered through
- 2027
- Brand names listed
- BAYONET IMPACTOR HANDLE, BLUNT DISTRACTOR, BONE HARVESTER, BOX OSTEOTOME, Battery Powered System, accessories, and attachments, CERVICAL BONE IMPACTOR, COMPRESSOR, CONTINUUM HIP SYSTEM (CHS) 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 |
|---|---|---|---|---|---|---|
| March 29, 2023 | K230243 | ROSA® Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| October 4, 2022 | K221928 | ROSA® Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| April 19, 2021 | K210121 | ROSA Partial Knee System | OLO | Substantially Equivalent | Orthosoft D/B/A Zimmer Cas | accessdata.fda.gov |
| September 5, 2019 | K191625 | Persona Revision Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| October 25, 2018 | K181947 | Persona Revision Knee System | JWH | Substantially Equivalent | Zimmer, Inc. | accessdata.fda.gov |
| June 29, 2012 | K120990 | NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL | MBH | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| November 23, 2011 | K111119 | TRABECULAR METAL (TM) FUSION DEVICE | ODP | Substantially Equivalent | Zimmer Spine, Inc. | accessdata.fda.gov |
| February 15, 2011 | K103517 | TRABECULAR METAL FEMORAL CONE AUGMENTS | MBH | Substantially Equivalent | Zimmer Trabecular Metal Technology, Inc. | accessdata.fda.gov |
| December 13, 2010 | K102896 | TRABECULAR METAL TIBIAL CONE AUGMENTS | MBH | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| June 29, 2007 | K071090 | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION | KWS | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| May 30, 2007 | K070382 | VISTA -S DEVICE | MQP | Substantially Equivalent | Zimmer Trabecular Metal Technology | accessdata.fda.gov |
| May 25, 2006 | K061067 | TRABECULAR METAL ACETABULAR AUGMENTS | LPH | Substantially Equivalent | Zimmer Trabecular | accessdata.fda.gov |
| February 27, 2006 | K053340 | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS | MBH | Substantially Equivalent | Zimmer Trabecular | accessdata.fda.gov |
| July 27, 2005 | K051756 | MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ | JWH | Substantially Equivalent | Zimmer Trabecular | accessdata.fda.gov |
| May 26, 2005 | K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | HWE | Substantially Equivalent | Zimmer Trabecular | accessdata.fda.gov |
| May 11, 2005 | K050937 | TRABECULAR METAL ACETABULAR REVISION SHELLS | LPH | Substantially Equivalent | Zimmer Trabecular | accessdata.fda.gov |
| April 15, 2005 | K050101 | THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 | HRS | Substantially Equivalent | Zimmer Trabecular | accessdata.fda.gov |
| December 21, 2004 | K042871 | TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 | LPH | Substantially Equivalent | Zimmer Trabecular | accessdata.fda.gov |
| December 21, 2004 | K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS | MBH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| January 8, 2004 | K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS | JWH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| August 6, 2003 | K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS | MBH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| July 11, 2003 | K031823 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 | MQP | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| January 15, 2003 | K024161 | NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS | JWH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| February 12, 2002 | K020295 | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 | JWH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| September 26, 2001 | K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 | JWH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| July 19, 2001 | K011904 | NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) | JWH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| January 25, 2001 | K004013 | IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY | JWH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| November 7, 2000 | K003181 | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ | LPH | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| August 24, 2000 | K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | JDI | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| March 1, 2000 | K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | JDI | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| August 6, 1997 | K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED | JDI | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
| February 3, 1997 | K962468 | HEDROCEL ACETABULAR RESTRICTOR | JDI | Substantially Equivalent | Implex Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 1, 2019 | 82125 | Class II | Terminated | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where seve | Potentially comingled, resulting in the product in the box potentially not matching the product on the label | accessdata.fda.gov |
| July 7, 2016 | 76652 | Class III | Terminated | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to repl | This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016. | accessdata.fda.gov |
| April 15, 2016 | 73536 | Class II | Terminated | POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541 | Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity. | accessdata.fda.gov |
| February 4, 2015 | 70605 | Class II | Terminated | NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total | One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. | accessdata.fda.gov |
| December 2, 2014 | 69866 | Class II | Terminated | NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 U | During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle. | accessdata.fda.gov |
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Updated March 29, 2023. 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.