Zimmer GmbH: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Zimmer GmbH” (first 2004, latest 2023), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. Since 2017 the median was 50 days, against 118 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 |
|---|---|---|
| 2012 | 4 | 84 |
| 2013 | 3 | 58 |
| 2014 | 1 | 89 |
| 2015 | 0 | — |
| 2016 | 3 | 72 |
| 2017 | 3 | 85 |
| 2018 | 1 | 158 |
| 2019 | 8 | 36 |
| 2020 | 3 | 83 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 642 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zimmer GmbH took a median 50 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 | 11 |
| HRS | Plate, Fixation, Bone | 7 | 7 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 5 | 5 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 4 | 4 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 3 | 3 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 | 1 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (43)
Most recent Zimmer GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211047 | CoCr Head | LPH | 2023-01-10 | 642 |
| K200814 | Affixus(R) Natural Nail(R) System Humeral Nail | HSB | 2020-04-28 | 29 |
| K200112 | Zimmer Hip Joint Replacement | LZO | 2020-04-10 | 84 |
| K193099 | Anatomical Shoulder System | PHX | 2020-01-29 | 83 |
| K193050 | Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem | LZO | 2019-12-26 | 55 |
| K193030 | Avenir Muller Stem, Avenir Cemented Hip Stem | LZO | 2019-12-06 | 37 |
| K192236 | Fitmore Hip Stem | KWY | 2019-11-05 | 78 |
| K192312 | Zimmer Natural Nail System Cephalomedullary Nails | HSB | 2019-10-11 | 46 |
| K192416 | BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System | LZO | 2019-10-01 | 27 |
| K192217 | NCB Plating System Distal Femur and Proximal Tibia | HRS | 2019-09-13 | 29 |
33 earlier clearances. See the full list in Caduvo.
Recalls
99 product recalls in 14 recall events; 2 initiated in the last five years. Most recent: 2024-08-08.
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 GmbH is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT02337244: Zimmer POLAR Persona - TKA (EMEA Study) (Active not recruiting, started 2013-11-18)
- NCT02466321: Anatomical Shoulder™ Inverse/Reverse Study (Completed, started 2007-05-16)
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. (379 510(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 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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zimmer GmbH?
FDA lists 43 510(k) clearances under the applicant name “Zimmer GmbH” (first 2004, latest 2023), across 12 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 GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer GmbH is 83 days. Since 2017: 50 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zimmer GmbH?
The most frequent FDA product codes under this applicant name are LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 11); HRS (Plate, Fixation, Bone, 7); HSB (Rod, Fixation, Intramedullary And Accessories, 6).
Next steps
- See all 43 Zimmer GmbH clearances with predicates and recalls
- Run predicate analysis for product code LZO, Zimmer GmbH'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.