Exactech, Inc.: FDA clearances and approvals
Exactech, Inc. has 186 FDA 510(k) clearances (first 1986, latest 2026), plus 1 PMA decision, across 40 product codes in 2 review panels. Median 510(k) review time: 86 days. Since 2017 its median was 134 days, against 101 days for all cleared 510(k)s in the same product codes. openFDA lists 221 product recalls by a recalling firm named Exactech, Inc. It is the industry lead sponsor of 5 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 8 | 122 |
| 2013 | 8 | 99 |
| 2014 | 8 | 105 |
| 2015 | 9 | 107 |
| 2016 | 6 | 103 |
| 2017 | 6 | 129 |
| 2018 | 8 | 88 |
| 2019 | 4 | 150 |
| 2020 | 2 | 186 |
| 2021 | 0 | — |
| 2022 | 1 | 218 |
| 2023 | 6 | 268 |
| 2024 | 2 | 252 |
| 2025 | 4 | 260 |
| 2026 | 1 | 53 |
Review time against the same product codes
Since 2017, Exactech, Inc.'s cleared 510(k)s took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 32 | 32 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 21 | 21 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 21 | 21 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 19 | 19 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 12 | 12 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 8 | 8 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 8 | 8 |
| LOD | Bone Cement | 5 | 5 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 5 | 5 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 4 | 4 |
Plus 30 more product codes.
Review panels
- Orthopedic (185)
- Dental (1)
Most recent Exactech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260583 | Equinoxe® Shoulder System | PHX | 2026-04-14 | 53 |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | KWT | 2025-12-01 | 266 |
| K243448 | Equinoxe® Shoulder System | PHX | 2025-08-01 | 267 |
| K243275 | Equinoxe® Scapula Fracture System | HRS | 2025-06-26 | 253 |
| K243839 | Alteon® HA Femoral Stems | MEH | 2025-03-10 | 87 |
| K240393 | Exactech® TRULIANT® Knee System | MBH | 2024-10-03 | 238 |
| K233482 | Equinoxe® Central Screw Baseplate System | PHX | 2024-07-18 | 266 |
| K230717 | Exactech® Vantage® Total Ankle System | HSN | 2023-10-12 | 211 |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | HRS | 2023-09-25 | 269 |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | PHX | 2023-09-14 | 266 |
176 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050039 | PMA | NOVATION CERAMIC ARTICULATION HIP SYSTEM | 2007-07-05 |
Recalls
221 product recalls in 71 recall events; 63 initiated in the last five years. Most recent: 2026-02-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Exactech, Inc. is the industry lead sponsor of 5 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07107581: Exactech Knee Systems Post Market Clinical Follow-up (Enrolling by invitation, started 2023-12-01)
- NCT05849961: Exactech Hip Systems Post-Market Clinical Follow-up (PMCF) (Recruiting, started 2023-10-13)
- NCT05516381: Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment (Recruiting, started 2023-05-15)
- NCT05653102: A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System (Recruiting, started 2019-01-23)
- NCT05788757: Optetrak Knee System Post Market Clinical Follow-Up (Active not recruiting, started 2011-06-01)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Exactech, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Exactech, Inc. have?
Exactech, Inc. has 186 FDA 510(k) clearances (first 1986, latest 2026), plus 1 PMA decision, across 40 product codes in 2 review panels.
How long does FDA take to clear Exactech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Exactech, Inc.'s cleared 510(k)s is 86 days. Since 2017: 134 days, versus 101 days for all cleared 510(k)s in the same product codes.
What devices does Exactech, Inc. make?
Its most frequent FDA product codes are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 32); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 21); PHX (Shoulder Prosthesis, Reverse Configuration, 21).
Has Exactech, Inc. had device recalls?
openFDA lists 221 product recalls in 71 recall events by a recalling firm whose name matches Exactech, Inc; the most recent began 2026-02-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 186 Exactech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Exactech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.