Cleared Traditional

BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW (K982398) - FDA 510(k) Clearance

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

K982398 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
32d
Days
Class 2
Risk

K982398 is an FDA 510(k) clearance for the BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 11, 1998 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3150 - 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 K982398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1998
Decision Date August 11, 1998
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDC Prosthesis, Elbow, Constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3150
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 - JDC Prosthesis, Elbow, Constrained, Cemented

All 21
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K982398.
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683 · Biomet, Inc. · Jun 2000
DEPUY TOTAL ELBOW SYSTEM
K992656 · DePuy Orthopaedics, Inc. · Nov 1999
SINGLE AXLE TOTAL ELBOW
K983036 · Biomet, Inc. · Apr 1999
BIOMET BIAXIAL TOTAL ELBOW
K980428 · Biomet, Inc. · May 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · Osteonics Corp. · May 1998
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
K973357 · Zimmer, Inc. · Mar 1998