COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE— 510(k) K120121

Clearance details

Applicant

Biomet, Inc.

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2012-01-17

Decision date

2012-02-16

Decision

Substantially Equivalent

Clearance type

Special

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-0093-2021 — Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).Class II·Terminated·Biomet, Inc.·20200902
• Z-1615-2020 — Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589Class II·Terminated·Biomet, Inc.·20200225
• Z-0972-2019 — Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are 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·Zimmer Biomet, Inc.·20181221
• Z-1208-2015 — Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400Class II·Terminated·Biomet, Inc.·20150107

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120121.