Cleared Traditional

BI-ANGULAR SHOULDER SYSTEM (K032895) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032895 · Biomet, Inc. · Orthopedic device
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Nov 2003
Decision
64d
Days
Class 2
Risk

K032895 is an FDA 510(k) clearance for the BI-ANGULAR SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

Submission Details

510(k) Number K032895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date November 20, 2003
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 28
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K032895.
COFIELD TOTAL SHOULDER SYSTEM
K070565 · Smith & Nephew, Inc. · May 2007
GLOBAL AP POROUS COATED HUMERAL STEM
K063652 · DePuy Orthopaedics, Inc. · Feb 2007
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
K043100 · Biomet, Inc. · Feb 2005
INTERLOK / HA COPELAND RESURFACING HEADS
K010635 · Biomet, Inc. · Aug 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · DePuy Orthopaedics, Inc. · Jul 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · DePuy Orthopaedics, Inc. · Jun 2001