Zimmer Biomet: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zimmer Biomet” (first 2024, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 60 days, against 100 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2024 | 1 | 63 |
| 2025 | 4 | 60 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zimmer Biomet took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Zimmer Biomet 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251834 | Persona Partial Knee | HSX | 2025-08-15 | 60 |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | JDI | 2025-07-31 | 255 |
| K251620 | A.L.P.S. Proximal Humerus Plating System | HRS | 2025-07-25 | 59 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | LZO | 2025-04-18 | 30 |
| K243293 | Zimmer® Persona® Personalized Knee System | MBH | 2024-12-20 | 63 |
Recalls
875 product recalls in 144 recall events; 0 initiated in the last five years. Most recent: 2020-11-20.
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.
Device clinical trials
An industry sponsor named Zimmer Biomet is the lead sponsor of 146 device studies on ClinicalTrials.gov (61 active or recruiting). Most recent:
- NCT07485829: Zimmer Biomet-RibFix Titan (Recruiting, started 2026-03-31)
- NCT05199870: MDR - PMCF Study for RingLoc Bipolar Acetabular Cup and Endo II Femoral Heads (Enrolling by invitation, started 2026-03-10)
- NCT07286513: Persona SoluTion PPS Femur PMCF (Enrolling by invitation, started 2026-02-26)
- NCT07150221: MDR Vivacit-E Elevated Study (Enrolling by invitation, started 2026-01-07)
- NCT07104279: Z1 Hip System: Post-Market Clinical Follow Up Study (Recruiting, started 2025-10-13)
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 Trabecular (10 510(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 Biomet?
FDA lists 5 510(k) clearances under the applicant name “Zimmer Biomet” (first 2024, latest 2025), across 5 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 Biomet?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer Biomet is 60 days. Since 2017: 60 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zimmer Biomet?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 1); HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, 1); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 1).
Next steps
- See all 5 Zimmer Biomet clearances with predicates and recalls
- Run predicate analysis for product code HRS, Zimmer Biomet'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.