Cleared Traditional

K961571 - COCR BI-ANGULAR HUMERAL COMPONENT

K961571 is an FDA 510(k) clearance for COCR BI-ANGULAR HUMERAL COMPONENT, 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 104-day FDA review.

K961571 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
104d
Days
Class 2
Risk

K961571 is an FDA 510(k) clearance for the COCR BI-ANGULAR HUMERAL COMPONENT. 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 5, 1996 after a review of 104 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 - K961571

510(k) Number K961571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1996
Decision Date August 05, 1996
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 67
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K961571.
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
K960424 · Endotec, Inc. · Aug 1996
SELECT SHOULDER KEELED ALL-POLY GLENOIDS
K962238 · Intermedics Orthopedics · Aug 1996
SELECT SHOULDER PEGGED ALL-POLY GLENOID
K962244 · Intermedics Orthopedics · Aug 1996
KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
K940537 · Kirschner Medical Corp. · Aug 1995
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · Biomet, Inc. · Oct 1994
SELECT(R) SHOULDER ALL-POLY GLENOID
K931114 · Intermedics Orthopedics · May 1994