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510(k) K173411

Comprehensive Segmental Revision System (SRS) by Biomet Manufacturing Corp — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2018
Date Received
November 1, 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.

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  • K193038 — Comprehensive Shoulder System (October 28, 2020)
  • K182516 — Comprehensive Nano Stemless Shoulder (April 22, 2019)
  • K181611 — Comprehensive Reverse Shoulder System (September 24, 2018)
  • K172502 — Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Co (January 3, 2018)
  • K163651 — ExpressBraid Graft Manipulation (February 17, 2017)
  • K152754 — COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) (May 16, 2016)

Other clearances for product code PHX

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  • 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)