Comprehensive Reverse Shoulder - HA Glenosphere Baseplates— 510(k) K252404
Substantially EquivalentBiomet Orthopedics
FDA 510(k) clearance K252404 for Comprehensive Reverse Shoulder - HA Glenosphere Baseplates, Substantially Equivalent on 2026-04-15. Applicant: Biomet Orthopedics. Device class: 2.
Summary
Biomet Orthopedics' Comprehensive Reverse Shoulder - HA Glenosphere Baseplates are filed under product code PHX (Shoulder Prosthesis, Reverse Configuration). The record doesn't describe the baseplates beyond their name and that code name.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Biomet Orthopedics filed from Warsaw, Indiana. The decision came 258 calendar days after FDA received it (July 31, 2025 to April 15, 2026).
Clearance details
- Applicant
- Biomet Orthopedics
- Product code
- Product code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code PHX
view allMore clearances from Biomet Orthopedics
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
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.