FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
K Number: K242377
·
Decision Oct 2, 2024
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
11
Review Days
54
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Basic Information
- Device Name
- REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component
- K Number
- K242377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteoremedies, LLC
- Date Received
- August 9, 2024
- Decision Date
- October 2, 2024
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Osteoremedies, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K253675 | OsteoRemedies Hip Spacer System | Dec 23, 2025 | Substantially Equivalent |
| K250760 | SPECTRUM GV Bone Cement | Apr 2, 2025 | Substantially Equivalent |
| K231556 | SPECTRUM® GV Bone Cement | Dec 20, 2023 | Substantially Equivalent |
| K223650 | REMEDY Stemmed Knee Spacer | Jan 5, 2023 | Substantially Equivalent |
| K192995 | OsteoRemedies Hip Spacer System | Jan 10, 2020 | Substantially Equivalent |
| K191981 | REMEDY Acetabular Cup | Aug 23, 2019 | Substantially Equivalent |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Jul 25, 2019 | Substantially Equivalent |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Aug 29, 2018 | Substantially Equivalent |
| K173967 | Remedy Acetabular Cup | Feb 22, 2018 | Substantially Equivalent |
| K152267 | Remedy® Shoulder Spacer | Dec 15, 2015 | Substantially Equivalent |