Zimmer Trabecular: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Zimmer Trabecular” (first 2004, latest 2006), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Zimmer Biomet, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Zimmer Trabecular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061155 | VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | 2006-09-22 | 149 |
| K061067 | TRABECULAR METAL ACETABULAR AUGMENTS | LPH | 2006-05-25 | 38 |
| K053340 | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS | MBH | 2006-02-27 | 88 |
| K052950 | THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | 2005-11-16 | 27 |
| K051756 | MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ | JWH | 2005-07-27 | 28 |
| K050766 | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | HWE | 2005-05-26 | 62 |
| K050937 | TRABECULAR METAL ACETABULAR REVISION SHELLS | LPH | 2005-05-11 | 27 |
| K050101 | THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 | HRS | 2005-04-15 | 87 |
| K042871 | TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 | LPH | 2004-12-21 | 64 |
| K043061 | THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX | KWS | 2004-11-23 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Zimmer Trabecular.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Zimmer, Inc. (422 510(k)s)
- Zimmer Spine, Inc. (43 510(k)s)
- Zimmer Dental, Inc. (40 510(k)s)
- Zimmer Biomet Spine, Inc. (15 510(k)s)
- Zimmer Medizinsysteme GmbH (13 510(k)s)
- Zimmer Trabecular Metal Technology (13 510(k)s)
- Zimmer Elektromedizin GmbH (12 510(k)s)
- Zimmer Biomet (5 510(k)s)
- Zimmer Switzerland Manufacturing GmbH (4 510(k)s)
- Zimmer Cas (3 510(k)s)
- Zimmer Patient Care Division (3 510(k)s)
- Zimmer Austin, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zimmer Trabecular?
FDA lists 10 510(k) clearances under the applicant name “Zimmer Trabecular” (first 2004, latest 2006), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zimmer Trabecular?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer Trabecular is 50 days.
Which FDA product codes appear under Zimmer Trabecular?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 3); MQP (Spinal Vertebral Body Replacement Device, 2); HRS (Plate, Fixation, Bone, 1).
Next steps
- See all 10 Zimmer Trabecular clearances with predicates and recalls
- Run predicate analysis for product code LPH, Zimmer Trabecular's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.