FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K Number: K252416
·
Decision Oct 29, 2025
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
529
Review Days
89
Basic Information
- Device Name
- AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K Number
- K252416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew, Inc.
- Date Received
- August 1, 2025
- Decision Date
- October 29, 2025
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWS), ordered by most recent decision date.
AETOS Shoulder System - CONCELOC Glenoids
FDA 510(k)
FDA Class 2
·Orthopedic
Catalyst F1x Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
MyShoulder Planner (5.3SSWPL)
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Humeral Reconstruction System (Tornier HRS)
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Univers Apex OptiFit Humeral Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Smith & Nephew, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Apr 6, 2026 | 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 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Oct 21, 2024 | Substantially Equivalent |