Catalyst F1x Shoulder System— 510(k) K252418
Substantially EquivalentCatalyst Orthoscience, Inc.
FDA 510(k) clearance K252418 for Catalyst F1x Shoulder System, Substantially Equivalent on 2025-11-06. Applicant: Catalyst Orthoscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Catalyst Orthoscience, Inc.
- Product code
- 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
- Naples, FL, US
Recent devices under product code KWS
view all- K260721 — Tornier Perform Advanced Glenoid
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K241292 — MyShoulder Planner (5.3SSWPL)
- K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
More clearances from Catalyst Orthoscience, Inc.
view allAdverse 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.