Extremity Medical, LLC: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Extremity Medical, LLC” (first 2008, latest 2025), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 68 days. Since 2017 the median was 58 days, against 90 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 72 |
| 2013 | 1 | 84 |
| 2014 | 1 | 122 |
| 2015 | 4 | 26 |
| 2016 | 1 | 58 |
| 2017 | 2 | 100 |
| 2018 | 2 | 42 |
| 2019 | 1 | 62 |
| 2020 | 2 | 148 |
| 2021 | 2 | 30 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 3 | 226 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Extremity Medical, LLC took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 16 | 16 |
| HRS | Plate, Fixation, Bone | 6 | 6 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 | 1 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 1 | 1 |
Review panels
- Orthopedic (28)
Most recent Extremity Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250536 | MetaFore Small Screw System | HWC | 2025-10-08 | 226 |
| K251128 | Extremity Medical External Fixation System | KTT | 2025-05-07 | 26 |
| K241563 | Extremity Medical External Fixation System | KTT | 2025-02-21 | 266 |
| K212297 | Omni Foot and Ankle Plating System | HRS | 2021-08-20 | 29 |
| K211261 | Axis Charcot Fixation System | HWC | 2021-05-28 | 32 |
| K201556 | Intraosseous Fixation System | HWC | 2020-07-08 | 28 |
| K191525 | KinematX Total Wrist Arthroplasty System | JWJ | 2020-03-04 | 268 |
| K192592 | Axis Plating System | HRS | 2019-11-21 | 62 |
| K181067 | AlignX Ankle Fusion System | HRS | 2018-05-23 | 30 |
| K180808 | Omni Foot Plating System | HRS | 2018-05-22 | 55 |
18 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2013-01-10.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Extremity Medical, LLC?
FDA lists 28 510(k) clearances under the applicant name “Extremity Medical, LLC” (first 2008, latest 2025), across 6 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 Extremity Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Extremity Medical, LLC is 68 days. Since 2017: 58 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Extremity Medical, LLC?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 16); HRS (Plate, Fixation, Bone, 6); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 2).
Next steps
- See all 28 Extremity Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code HWC, Extremity Medical, LLC'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.