OsteoRemedies Hip Spacer System
FDA 510(k) K253675 · Osteoremedies, LLC
510(k) numberK253675
Submission
- Device name
- OsteoRemedies Hip Spacer System
- Applicant
- Osteoremedies, LLC
Germantown, TN, US - Received
- November 21, 2025
- Decision date
- December 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | Osteoremedies, LLC | 07/24/2026SE |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL · Traditional | Depuy Ireland UC | 05/15/2026SE |
| K252326 | InterSpace GV Hip SpacerKWL · Special | Tecres S.P.A. | 08/06/2025SE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | Biocomposites, Ltd. | 06/12/2025SE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional | Heraeus Medical GmbH | 02/15/2024SE |
| K222632 | UHR Bipolar Implants, Restoration GAP II ImplantsKWL · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/21/2022SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | Osteoremedies, LLC | 08/23/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | Osteoremedies, LLC | 08/29/2018SE |
| K173967 | Remedy Acetabular CupKWL · Traditional | Osteoremedies, LLC | 02/22/2018SE |
More from Osteoremedies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | 07/24/2026SE |
| K250760 | SPECTRUM GV Bone CementLOD · Special | 04/02/2025SE |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentJWH · Traditional | 10/02/2024SE |
| K231556 | SPECTRUM® GV Bone CementLOD · Traditional | 12/20/2023SE |
| K223650 | REMEDY Stemmed Knee SpacerJWH · Special | 01/05/2023SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | 08/23/2019SE |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerJWH · Traditional | 07/25/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | 08/29/2018SE |
| K173967 | Remedy Acetabular CupKWL · Traditional | 02/22/2018SE |
Questions and answers
When was OsteoRemedies Hip Spacer System cleared by the FDA?
OsteoRemedies Hip Spacer System (K253675) received a 510(k) decision of Substantially Equivalent on December 23, 2025, 32 days after the submission was received.
What is the product code of K253675?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.