FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
K Number: K960279
·
Decision Apr 26, 1996
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
376
Review Days
98
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
- K Number
- K960279
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zimmer, Inc.
- Date Received
- January 19, 1996
- Decision Date
- April 26, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Zimmer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261683 | Augment Off-Axis Instrument System | Jun 16, 2026 | Substantially Equivalent |
| K260831 | Z1 Hip System | Jun 16, 2026 | Substantially Equivalent |
| K251840 | Zimmer® Persona® Personalized Knee System | May 28, 2026 | Substantially Equivalent |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | Apr 27, 2026 | Substantially Equivalent |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) | Apr 13, 2026 | Substantially Equivalent |
| K253566 | Affixus Retrograde Femoral Nailing System | Mar 12, 2026 | Substantially Equivalent |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Mar 9, 2026 | Substantially Equivalent |
| K252623 | G7® Revision Acetabular System | Feb 4, 2026 | Substantially Equivalent |
| K251098 | Identity Revision Humeral Stems | Aug 11, 2025 | Substantially Equivalent |
| K251906 | Z1 Hip System | Jul 18, 2025 | Substantially Equivalent |