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510(k) K252404

Comprehensive Reverse Shoulder - HA Glenosphere Baseplates by Biomet Orthopedics — Product Code PHX

K252404 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics for the device "Comprehensive Reverse Shoulder - HA Glenosphere Baseplates". The FDA issued a decision of Substantially Equivalent on April 15, 2026. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660. Biomet Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
July 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Prosthesis, Reverse Configuration
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Other clearances by Biomet Orthopedics

  • K243761 — A.L.P.S. Small Fragment Plating System (February 19, 2025)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K200196 — Taperloc® Complete Hip Stems (December 8, 2020)
  • K131393 — MAK OSS FEMORAL KNEE COMPONENTS (October 24, 2013)
  • K112905 — COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (May 24, 2012)
  • K080528 — E-POLY TIBIAL BEARINGS (June 17, 2008)
  • K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM (January 14, 2008)
  • K070955 — ACID ETCHED LAG SCREWS (October 12, 2007)
  • K033355 — LACTOSCREW SCREW ANCHOR (June 30, 2004)
  • K032286 — CALCIGEN PSI BONE GRAFT SUBSTITUTE (November 20, 2003)

Other clearances for product code PHX

  • K260556 — Veritas Shoulder System (July 1, 2026)
  • K261683 — Augment Off-Axis Instrument System (June 16, 2026)
  • K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid (June 12, 2026)
  • K261016 — MSS - Humeral reverse liners extension (June 10, 2026)
  • K253992 — Veritas Reverse Total Shoulder System (May 7, 2026)
  • K260583 — Equinoxe® Shoulder System (April 14, 2026)
  • K254128 — InSet Reverse Total Shoulder System (April 13, 2026)
  • K253674 — Blueprint Patient-Specific Instrumentation (April 3, 2026)
  • K253624 — INHANCE™ Reverse Shoulder System (March 11, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)

FDA data resources