Medical device manufacturer
Exactech, Inc.
Exactech, Inc. holds 186 FDA 510(k) clearances across 38 product codes. Median elapsed review time is 86 days. openFDA lists 221 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 186
- Product codes
- 38
- Median review
- 86 days
- Recall records
- 221
How does FDA spell Exactech, Inc.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| EXACTECH, INC. | device/registrationlisting | normalised |
| Exactech, Inc. | device/enforcement | normalised |
| Exactech, Inc. | device/510k | normalised |
| Exactech, Inc. | device/recall | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Exactech, Inc. file in?
38 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 32 | 60 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 21 | 85 days | |
| PHX | Shoulder Prosthesis, Reverse Configuration | 21 | 86 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 19 | 65 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 12 | 30 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 8 | 32 days | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 8 | 87 days | |
| LOD | Bone Cement | 5 | 20 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 5 | 90 days | |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 4 | 90 days | |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 4 | 119 days | |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 4 | 107 days | |
| HRS | Plate, Fixation, Bone | 3 | 253 days | |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 | 70 days | |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 108 days | |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 3 | 177 days | |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 144 days | |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 127 days | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 49 days | |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 2 | 30 days | |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 29 days | |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 2 | 172 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 179 days | |
| HWC | Screw, Fixation, Bone | 1 | 15 days | |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 61 days |
Showing the 25 they file in most, of 38.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Exactech, Inc. had a recall?
openFDA lists 221 recall records naming this company across its whole history, of which 7 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1509-2026Class IIOpen, ClassifiedHWA
Impactor handle may be missing cross-pin
Z-1510-2026Class IIOpen, ClassifiedHWA
Impactor handle may be missing cross-pin
Z-0535-2026Class IIOpen, ClassifiedPHX
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Z-0536-2026Class IIOpen, ClassifiedPHX
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Z-0537-2026Class IIOpen, ClassifiedPHX
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Showing the 5 most recently initiated of 221.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Exactech, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260583 | Equinoxe® Shoulder System | PHX | 53 | |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | KWT | 266 | |
| K243448 | Equinoxe® Shoulder System | PHX | 267 | |
| K243275 | Equinoxe® Scapula Fracture System | HRS | 253 | |
| K243839 | Alteon® HA Femoral Stems | MEH | 87 | |
| K240393 | Exactech® TRULIANT® Knee System | MBH | 238 | |
| K233482 | Equinoxe® Central Screw Baseplate System | PHX | 266 | |
| K230717 | Exactech® Vantage® Total Ankle System | HSN | 211 | |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | HRS | 269 | |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | PHX | 266 |
Source: openFDA device/510k · retrieved
Where is Exactech, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Exactech, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.