FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Resolve Modular Revision Hip Stem
K Number: K242315
·
Decision May 1, 2025
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
40
Review Days
269
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Basic Information
- Device Name
- Resolve Modular Revision Hip Stem
- K Number
- K242315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United Orthopedic Corporation
- Date Received
- August 5, 2024
- Decision Date
- May 1, 2025
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
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Other Clearances by United Orthopedic Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | Sep 25, 2025 | Substantially Equivalent |
| K252303 | Stem Extension Line (USTAR II System) | Aug 22, 2025 | Substantially Equivalent |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | Jul 31, 2025 | Substantially Equivalent |
| K243466 | Conformity Stem Extension Line, #0 | Jan 6, 2025 | Substantially Equivalent |
| K243024 | Cellbrick Knee Spacer | Dec 20, 2024 | Substantially Equivalent |
| K242249 | Conformity Stem Extension Line | Aug 30, 2024 | Substantially Equivalent |
| K221705 | U2 Total Knee System-PF+ | Feb 28, 2023 | Substantially Equivalent |
| K221149 | U-Motion II Acetabular System-Extension line | Jan 5, 2023 | Substantially Equivalent |
| K221675 | United U2 femoral head, 22mm delta ceramic head | Nov 4, 2022 | Substantially Equivalent |
| K222700 | Tibial baseplate, Tibial insert | Oct 6, 2022 | Substantially Equivalent |