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510(k) K172502

Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate by Biomet Manufacturing Corp — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2018
Date Received
August 18, 2017
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 Manufacturing Corp

  • K230540 — Patient Specific Planning Solution™ 3D Bone Models (July 25, 2023)
  • K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (March 15, 2023)
  • K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner (November 4, 2021)
  • K202232 — Comprehensive Vault Reconstruction System (February 19, 2021)
  • K193038 — Comprehensive Shoulder System (October 28, 2020)
  • K182516 — Comprehensive Nano Stemless Shoulder (April 22, 2019)
  • K181611 — Comprehensive Reverse Shoulder System (September 24, 2018)
  • K173411 — Comprehensive Segmental Revision System (SRS) (February 8, 2018)
  • K163651 — ExpressBraid Graft Manipulation (February 17, 2017)
  • K152754 — COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) (May 16, 2016)

Other clearances for product code PHX

  • K253624 — INHANCE™ Reverse Shoulder System (March 11, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)
  • K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (January 22, 2026)
  • K252567 — AltiVate Reverse® ADLC Glenosphere (January 15, 2026)
  • K252516 — N22 EZ Glenosphere (January 15, 2026)
  • K254003 — JARVIS Metaphyseal Stem (January 9, 2026)
  • K252788 — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
  • K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
  • K253345 — JARVIS Diaphyseal Stem Standard (October 29, 2025)
  • K252221 — Inset Reverse Total Shoulder System (September 26, 2025)