COMPREHENSIVE REVERSE SHOULDER— 510(k) K080642

Clearance details

Applicant

Biomet, Inc.

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2008-03-06

Decision date

2008-07-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K260556 — Veritas Shoulder System2026-07-01
• K261683 — Augment Off-Axis Instrument System2026-06-16
• K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12
• K261016 — MSS - Humeral reverse liners extension2026-06-10
• K253992 — Veritas Reverse Total Shoulder System2026-05-07

• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K251270 — Taperloc® Complete Hip Stem2026-05-19
• K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
• K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Death

10

Injury

9,705

Malfunction

1,252

Total

10,967

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2144-2020 — Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.Class II·Terminated·Biomet, Inc.·20200417
• Z-1750-2020 — Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery 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.Class II·Terminated·Biomet, Inc.·20200313
• Z-1859-2017 — various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow ReplacementClass II·Terminated·Zimmer Biomet, Inc.·20170217
• Z-1103-2017 — Comprehensive Reverse Shoulder System Humeral Tray Model 115340Class I·Terminated·Zimmer Biomet, Inc.·20161220
• Z-1548-2013 — Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.Class II·Terminated·Biomet, Inc.·20130515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080642.