MODULAR HYBRID GLENOID— 510(k) K060694

Clearance details

Applicant

Biomet Manufacturing Corp

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2006-03-15

Decision date

2006-12-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K260721 — Tornier Perform Advanced Glenoid2026-07-22
• K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
• K252418 — Catalyst F1x Shoulder System2025-11-06
• K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
• K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

• 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

Death

6

Injury

9,652

Malfunction

1,385

Other

1

Total

11,044

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-2216-2017 — Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20170426
• 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-0660-2013 — PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedClass II·Terminated·Biomet, Inc.·20061212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060694.