Cleared Traditional

Comprehensive Humeral Fracture Positioning Sleeves

K212435 · Biomet, Inc. · Orthopedic

Dec 2021

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K212435 is an FDA 510(k) clearance for the Comprehensive Humeral Fracture Positioning Sleeves, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 10, 2021, 128 days after receiving the submission on August 4, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K212435 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2021
Decision Date	December 10, 2021
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660