Zimmer, Inc.: FDA filings under this applicant name
FDA lists 379 510(k) clearances under 2 spellings of the applicant name “Zimmer, Inc.” (first 1976, latest 2026), plus 3 PMA decisions, across 81 product codes in 9 review panels. Median 510(k) review time under this name: 87 days. Since 2017 the median was 111 days, against 106 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 | 12 | 120 |
| 2013 | 10 | 96 |
| 2014 | 15 | 57 |
| 2015 | 19 | 88 |
| 2016 | 3 | 192 |
| 2017 | 2 | 53 |
| 2018 | 6 | 152 |
| 2019 | 13 | 140 |
| 2020 | 9 | 101 |
| 2021 | 3 | 60 |
| 2022 | 4 | 220 |
| 2023 | 1 | 30 |
| 2024 | 6 | 86 |
| 2025 | 5 | 93 |
| 2026 | 8 | 131 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zimmer, Inc. took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 51 | 51 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 45 | 45 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 27 | 27 |
| HRS | Plate, Fixation, Bone | 25 | 25 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 23 | 23 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 19 | 19 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 17 | 17 |
| HWC | Screw, Fixation, Bone | 12 | 12 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 10 | 10 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 9 | 9 |
Plus 71 more product codes.
Review panels
- Orthopedic (341)
- General and Plastic Surgery (12)
- General Hospital (6)
- Neurology (6)
- Physical Medicine (6)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
- Obstetrics and Gynecology (1)
- Radiology (1)
Most recent Zimmer, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261683 | Augment Off-Axis Instrument System | PHX | 2026-06-16 | 26 |
| K260831 | Z1 Hip System | LZO | 2026-06-16 | 95 |
| K251840 | Zimmer® Persona® Personalized Knee System | MBH | 2026-05-28 | 346 |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | LZO | 2026-04-27 | 96 |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | MBF | 2026-04-13 | 147 |
| K253566 | Affixus Retrograde Femoral Nailing System | HSB | 2026-03-12 | 115 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | MBH | 2026-03-09 | 164 |
| K252623 | G7® Revision Acetabular System | LPH | 2026-02-04 | 169 |
| K251098 | Identity Revision Humeral Stems | MBF | 2025-08-11 | 123 |
| K251906 | Z1 Hip System | LZO | 2025-07-18 | 28 |
369 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060037 | PMA | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM | 2007-12-10 |
| P040048 | PMA | TRILOGY AB ACETABULAR SYSTEM | 2006-06-28 |
| N17755 | PMA | ZIMMER(R) BONE CEMENT | 1976-05-17 |
Recalls
974 product recalls in 212 recall events; 71 initiated in the last five years. Most recent: 2026-05-20.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Zimmer, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Zimmer, Inc. (379)
- Zimmer (3)
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 Spine, Inc. (43 510(k)s)
- Zimmer GmbH (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, Inc.?
FDA lists 379 510(k) clearances under 2 spellings of the applicant name “Zimmer, Inc.” (first 1976, latest 2026), plus 3 PMA decisions, across 81 product codes in 9 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zimmer, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zimmer, Inc. is 87 days. Since 2017: 111 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zimmer, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 51); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 45); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 27).
Next steps
- See all 379 Zimmer, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Zimmer, Inc.'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.