Cleared Traditional

K984028 - THE NEW BIO-MOORE ENDO HEADS

K984028 is the FDA 510(k) clearance for THE NEW BIO-MOORE ENDO HEADS by Biomet, Inc.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K984028 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
68d
Days
Class 2
Risk

K984028 is an FDA 510(k) clearance for the THE NEW BIO-MOORE ENDO HEADS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 19, 1999 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K984028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date January 19, 1999
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 77
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K984028.
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · Howmedica Osteonics Corp. · Sep 1999
PLUS FRACTURE HEAD PROSTHESIS
K990309 · Plus Orthopedics · Mar 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · Osteonics Corp. · Feb 1999
ARGOMEDICAL BIPOLAR SYSTEM
K981451 · Stelkast Company · Aug 1998
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K974807 · Osteonics Corp. · Mar 1998
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · Encore Orthopedics, Inc. · Dec 1997