Cleared Traditional

BIO-MODULAR SHOULDER SYSTEM (K992119) - FDA 510(k) Clearance

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

K992119 · Biomet, Inc. · Orthopedic device
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Sep 1999
Decision
82d
Days
Class 2
Risk

K992119 is an FDA 510(k) clearance for the BIO-MODULAR SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 13, 1999 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 K992119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1999
Decision Date September 13, 1999
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 91
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K992119.
NEER III TOTAL SHOULDER SYSTEM
K994350 · Smith & Nephew, Inc. · May 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · DePuy Orthopaedics, Inc. · Mar 2000
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · Biomet, Inc. · Oct 1999
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
K992065 · DePuy Orthopaedics, Inc. · Jul 1999
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
K990598 · Howmedica Osteonics Corp. · Mar 1999
DEPUY GLOBAL SHOULDER GLENOID
K981487 · DePuy Orthopaedics, Inc. · Jul 1998