FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates
K Number: K230653
·
Decision May 4, 2023
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
529
Review Days
56
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Basic Information
- Device Name
- Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates
- K Number
- K230653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- March 9, 2023
- Decision Date
- May 4, 2023
- 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 Smith & Nephew, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Apr 6, 2026 | Substantially Equivalent |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Oct 29, 2025 | Substantially Equivalent |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Oct 3, 2025 | Substantially Equivalent |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) | Jun 25, 2025 | Substantially Equivalent |
| K243608 | TRIGEN Stable Lock Nut & Washer | Jun 12, 2025 | Substantially Equivalent |
| K250677 | LEGION Total Knee System | Apr 2, 2025 | Substantially Equivalent |
| K250571 | CATALYSTEM Femoral Stems | Mar 28, 2025 | Substantially Equivalent |
| K243364 | TRIGEN META-TAN Trochanteric Antegrade Nail | Dec 9, 2024 | Substantially Equivalent |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Nov 20, 2024 | Substantially Equivalent |
| K242711 | JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Oct 30, 2024 | Substantially Equivalent |