Osteoremedies, LLC
Memphis, TN, US
OSTEOREMEDIES, LLC appears in FDA device records in Memphis, TN. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Osteoremedies, LLC between 2015 and 2026. The busiest year on record is 2018, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | KWL | Substantially Equivalent | |
| K253675 | OsteoRemedies Hip Spacer System | KWL | Substantially Equivalent | |
| K250760 | SPECTRUM GV Bone Cement | LOD | Substantially Equivalent | |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | JWH | Substantially Equivalent | |
| K231556 | SPECTRUM® GV Bone Cement | LOD | Substantially Equivalent | |
| K223650 | REMEDY Stemmed Knee Spacer | JWH | Substantially Equivalent | |
| K192995 | OsteoRemedies Hip Spacer System | KWL | Substantially Equivalent | |
| K191981 | REMEDY Acetabular Cup | KWL | Substantially Equivalent | |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | JWH | Substantially Equivalent | |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | KWL | Substantially Equivalent | |
| K173967 | Remedy Acetabular Cup | KWL | Substantially Equivalent | |
| K152267 | Remedy® Shoulder Spacer | KWS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010537287 | 3010537287 | OSTEOREMEDIES, LLC | 6800 Poplar Ave Ste 120, Memphis, TN 38138 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LODBone Cement
- MBBBone Cement, Antibiotic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HXOPusher, Socket
- HWTTemplate
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain