Cleared Traditional

K980428 - BIOMET BIAXIAL TOTAL ELBOW

K980428 is an FDA 510(k) clearance for BIOMET BIAXIAL TOTAL ELBOW, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980428 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980428 is an FDA 510(k) clearance for the BIOMET 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 May 5, 1998 after a review of 90 days - within the typical 510(k) review window.

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: 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 - K980428

510(k) Number K980428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1998
Decision Date May 05, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDC Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K980428.
DEPUY TOTAL ELBOW SYSTEM
K992656 · DePuy Orthopaedics, Inc. · Nov 1999
SINGLE AXLE TOTAL ELBOW
K983036 · Biomet, Inc. · Apr 1999
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
K982398 · Biomet, Inc. · Aug 1998
OSTEONICS TOTAL ELBOW SYSTEM
K980502 · Osteonics Corp. · May 1998
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
K973357 · Zimmer, Inc. · Mar 1998
TOWNLEY TOTAL ELBOW SYSTEM
K955916 · Biologically Oriented Prostheses · Aug 1996