United Orthopedic Corporation: FDA clearances and approvals
United Orthopedic Corporation has 61 FDA 510(k) clearances (first 2000, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time: 179 days. Since 2017 its median was 250 days, against 105 days for all cleared 510(k)s in the same product codes. openFDA lists 12 product recalls by a recalling firm named United Orthopedic Corporation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 55 |
| 2013 | 7 | 163 |
| 2014 | 4 | 172 |
| 2015 | 3 | 179 |
| 2016 | 3 | 224 |
| 2017 | 7 | 261 |
| 2018 | 1 | 266 |
| 2019 | 2 | 248 |
| 2020 | 1 | 259 |
| 2021 | 1 | 21 |
| 2022 | 2 | 88 |
| 2023 | 2 | 260 |
| 2024 | 2 | 57 |
| 2025 | 5 | 59 |
| 2026 | 1 | 266 |
Review time against the same product codes
Since 2017, United Orthopedic Corporation's cleared 510(k)s took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 20 | 20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 15 | 15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 | 11 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 4 | 4 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 | 3 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 2 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (61)
Most recent United Orthopedic Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253948 | Momentum Acetabular Cup System | LZO | 2026-09-02 | 266 |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | JWH | 2025-09-25 | 28 |
| K252303 | Stem Extension Line (USTAR II System) | KRO | 2025-08-22 | 29 |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | MBH | 2025-07-31 | 247 |
| K242315 | Resolve Modular Revision Hip Stem | MEH | 2025-05-01 | 269 |
| K243466 | Conformity Stem Extension Line, #0 | LZO | 2025-01-06 | 59 |
| K243024 | Cellbrick Knee Spacer | JWH | 2024-12-20 | 84 |
| K242249 | Conformity Stem Extension Line | LZO | 2024-08-30 | 30 |
| K221705 | U2 Total Knee System-PF+ | MBH | 2023-02-28 | 260 |
| K221149 | U-Motion II Acetabular System-Extension line | LZO | 2023-01-05 | 260 |
51 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 5 recall events; 9 initiated in the last five years. Most recent: 2026-05-20.
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.
Frequently asked questions
How many FDA 510(k) clearances does United Orthopedic Corporation have?
United Orthopedic Corporation has 61 FDA 510(k) clearances (first 2000, latest 2026), across 10 product codes in 1 review panel.
How long does FDA take to clear United Orthopedic Corporation's 510(k)s?
The median time from FDA receipt to decision across United Orthopedic Corporation's cleared 510(k)s is 179 days. Since 2017: 250 days, versus 105 days for all cleared 510(k)s in the same product codes.
What devices does United Orthopedic Corporation make?
Its most frequent FDA product codes are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 20); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 15); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 11).
Has United Orthopedic Corporation had device recalls?
openFDA lists 12 product recalls in 5 recall events by a recalling firm whose name matches United Orthopedic Corporation; the most recent began 2026-05-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 61 United Orthopedic Corporation clearances with predicates and recalls
- Run predicate analysis for product code JWH, United Orthopedic Corporation'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.