BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD— 510(k) K915596

Name: FDA 510(k) clearance K915596
Creator: U.S. Food and Drug Administration
Published: 1992-03-11

Substantially Equivalent for Some Indications

Biomet, Inc.

FDA 510(k) clearance K915596 for BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD, Substantially Equivalent for Some Indications on 1992-03-11. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWT
Device class: Class 2
Regulation: 21 CFR 888.3650
Advisory panel: Orthopedic
Date received: 1991-12-13
Decision date: 1992-03-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWT

view all

K262173 — N22 Offset Humeral Head2026-09-08
K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
K241944 — AGILON® XO Shoulder Replacement System2025-03-10
K241817 — InSet Total Shoulder System2025-02-11

More clearances from Biomet, Inc.

view all

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

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.