Comprehensive Nano Stemless Shoulder— 510(k) K182516

Name: FDA 510(k) clearance K182516
Creator: U.S. Food and Drug Administration
Published: 2019-04-22

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K182516 for Comprehensive Nano Stemless Shoulder, Substantially Equivalent on 2019-04-22. Applicant: Biomet Manufacturing Corp. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code PKC
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2018-09-13
Decision date: 2019-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKC

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K254154 — FX V135 EASYTECH® Shoulder System2026-05-01
K252129 — AETOS Shoulder System Stemless Humeral Prosthesis2025-10-03
K243248 — INHANCE INTACT2024-12-23
K241873 — OsseoFit Stemless Shoulder System2024-12-11
K240716 — AETOS Shoulder System Stemless Humeral Prosthesis2024-11-20

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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

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.