AETOS Shoulder System - CONCELOC Glenoids— 510(k) K254084
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K254084 for AETOS Shoulder System - CONCELOC Glenoids, Substantially Equivalent on 2026-04-06. Applicant: Smith & Nephew, Inc.. Device class: 2.
Summary
Smith & Nephew's AETOS Shoulder System - CONCELOC Glenoids is filed under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented). The record doesn't describe the glenoids beyond their name and that code name.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Smith & Nephew filed from Cordova, Tennessee. The record shows 109 calendar days from receipt to decision (December 18, 2025 to April 6, 2026).
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Product code KWS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cordova, TN, US
Recent devices under product code KWS
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view all- K263461 — Tendon Anchor
- K263348 — Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue +5 more
- K261462 — LANDMARK Total Knee System
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
Adverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.