Cleared Traditional

K991585 - BIPOLAR SHOULDER PROSTHESIS

K991585 is an FDA 510(k) clearance for BIPOLAR SHOULDER PROSTHESIS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K991585 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
103d
Days
Class 2
Risk

K991585 is an FDA 510(k) clearance for the BIPOLAR SHOULDER PROSTHESIS. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 18, 1999 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K991585

510(k) Number K991585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1999
Decision Date August 18, 1999
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 66
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K991585.
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
K020045 · Biomet Orthopedics, Inc. · Jan 2002
EPOCA CODR STEM AND HEAD
K014049 · Stelkast Company · Jan 2002
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · Biomet, Inc. · Oct 2000
GRIT BLASTED HUMERAL STEM
K991603 · Encore Orthopedics, Inc. · Jun 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · DePuy Orthopaedics, Inc. · Jan 1999
NEW ZIMMER SHOULDER SYSTEM
K982981 · Zimmer, Inc. · Dec 1998