Osteoremedies, LLC: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Osteoremedies, LLC” (first 2015, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Since 2017 the median was 54 days, against 89 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 |
|---|---|---|
| 2015 | 1 | 126 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 198 |
| 2019 | 2 | 148 |
| 2020 | 1 | 77 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 117 |
| 2024 | 1 | 54 |
| 2025 | 2 | 26 |
| 2026 | 1 | 18 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osteoremedies, LLC took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 6 | 6 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| LOD | Bone Cement | 2 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Osteoremedies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | KWL | 2026-07-24 | 18 |
| K253675 | OsteoRemedies Hip Spacer System | KWL | 2025-12-23 | 32 |
| K250760 | SPECTRUM GV Bone Cement | LOD | 2025-04-02 | 20 |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | JWH | 2024-10-02 | 54 |
| K231556 | SPECTRUM® GV Bone Cement | LOD | 2023-12-20 | 204 |
| K223650 | REMEDY Stemmed Knee Spacer | JWH | 2023-01-05 | 30 |
| K192995 | OsteoRemedies Hip Spacer System | KWL | 2020-01-10 | 77 |
| K191981 | REMEDY Acetabular Cup | KWL | 2019-08-23 | 30 |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | JWH | 2019-07-25 | 267 |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | KWL | 2018-08-29 | 341 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Osteoremedies, LLC.
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 Osteoremedies, LLC?
FDA lists 12 510(k) clearances under the applicant name “Osteoremedies, LLC” (first 2015, latest 2026), across 4 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 Osteoremedies, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osteoremedies, LLC is 54 days. Since 2017: 54 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Osteoremedies, LLC?
The most frequent FDA product codes under this applicant name are KWL (Prosthesis, Hip, Hemi-, Femoral, Metal, 6); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 3); LOD (Bone Cement, 2).
Next steps
- See all 12 Osteoremedies, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWL, Osteoremedies, 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.