COMPREHENSIVE PRIMARY SHOULDER STEMS— 510(k) K060692

Clearance details

Applicant

Biomet Manufacturing Corp

Product code

Code MBF

Device class

Class 2

Regulation

21 CFR 888.3670

Advisory panel

Orthopedic

Date received

2006-03-15

Decision date

2006-05-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)2026-04-13
• K251098 — Identity Revision Humeral Stems2025-08-11
• K250848 — Identity Shoulder System2025-07-02
• K240876 — Identity Shoulder System2024-06-12
• K233712 — PRIMA Humeral System; PRIMA TT Glenoid2024-01-11

• K230540 — Patient Specific Planning Solution 3D Bone Models2023-07-25
• K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System2023-03-15
• K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner2021-11-04
• K202232 — Comprehensive Vault Reconstruction System2021-02-19
• K193038 — Comprehensive Shoulder System2020-10-28

Injury

597

Total

597

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-1543-2020 — Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.Class II·Terminated·Biomet, Inc.·20200217
• Z-0591-2019 — Comprehensive Mini Stem, Item No. 113631:Class II·Terminated·Zimmer Biomet, Inc.·20181010
• Z-0979-2018 — Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20171208
• Z-0980-2018 — Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20171208
• Z-0299-2018 — COMP PRIMARY STEM 8MM MINI, model # 113628Class II·Terminated·Zimmer Biomet, Inc.·20170605
• Z-1755-2015 — Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.Class III·Terminated·Biomet, Inc.·20150416

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060692.