FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
K Number: K243634
·
Decision Aug 25, 2025
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
98
Applicant Total
23
Review Days
273
Basic Information
- Device Name
- Maxx Libertas Bipolar Hip Head (Bipolar Hip)
- K Number
- K243634
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxx Orthopedics, Inc.
- Date Received
- November 25, 2024
- Decision Date
- August 25, 2025
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWY), ordered by most recent decision date.
b-ONE® Bipolar Head
FDA 510(k)
FDA Class 2
·Orthopedic
CORAIL Cemented Femoral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
SpaceFlex Acetabular Cup
FDA 510(k)
FDA Class 2
·Orthopedic
Vario-Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
COPAL exchange G hip spacer
FDA 510(k)
FDA Class 2
·Orthopedic
Kyocera Bipolar Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| 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 |
| K200912 | Freedom(R) - TiNbN Coated Knee | Nov 18, 2020 | Substantially Equivalent |