Cleared Traditional

SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM (K974558) - FDA 510(k) Clearance

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

K974558 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
89d
Days
Class 2
Risk

K974558 is an FDA 510(k) clearance for the SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 4, 1998 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 K974558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1997
Decision Date March 04, 1998
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K974558.
DUAL LOCK HIP STEM
K980794 · Depuy, Inc. · May 1998
ARTICUL/EZE FEMORAL HEADS
K980513 · DePuy Orthopaedics, Inc. · Apr 1998
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
K980286 · Johnson & Johnson Professionals, Inc. · Apr 1998
EXTEND HIP STEM
K973296 · Wrightmedicaltechnologyinc · Nov 1997
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
K972792 · Howmedica Corp. · Oct 1997
DUAL OFFSET PERFECTA IMC HIP STEM
K972641 · Wrightmedicaltechnologyinc · Oct 1997