FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Libertas Hip Replacement System
K Number: K180973
·
Decision Sep 28, 2018
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
23
Review Days
168
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Basic Information
- Device Name
- Libertas Hip Replacement System
- K Number
- K180973
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxx Orthopedics, Inc.
- Date Received
- April 13, 2018
- Decision Date
- September 28, 2018
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Maxx Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Jan 15, 2026 | Substantially Equivalent |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Oct 31, 2025 | Substantially Equivalent |
| K253314 | Freedom Infinia Total Knee System | Oct 29, 2025 | Substantially Equivalent |
| K253144 | Freedom® Total Knee System Titan PCK Components | Oct 22, 2025 | Substantially Equivalent |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Aug 25, 2025 | Substantially Equivalent |
| K251717 | Freedom® Total Knee System Titanium Tibial Base Plate | Jun 26, 2025 | Substantially Equivalent |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Mar 13, 2025 | Substantially Equivalent |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Feb 13, 2025 | Substantially Equivalent |
| K243277 | Freedom® Medial Congruent Liner | Nov 19, 2024 | Substantially Equivalent |
| K240863 | Freedom® Total Knee System | Jul 2, 2024 | Substantially Equivalent |