Cleared Traditional

PRECEDENT REVISION HIP SYSTEM (K972637) - FDA 510(k) Clearance

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

K972637 · Sulzer Orthopedics, Inc. · Orthopedic device
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Oct 1997
Decision
78d
Days
Class 2
Risk

K972637 is an FDA 510(k) clearance for the PRECEDENT REVISION HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Sulzer Orthopedics, Inc. devices

Submission Details

510(k) Number K972637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date October 01, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 292
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K972637.
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307 · Johnson & Johnson Professionals, Inc. · Nov 1997
PARTNERSHIP REVISION FEMORAL STEMS
K972893 · Howmedica Corp. · Nov 1997
ZIRCONIA CERAMIC FEMORAL HEAD
K972690 · Zimmer, Inc. · Oct 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431 · Biomet, Inc. · Aug 1997
ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)
K971752 · Zimmer, Inc. · Jul 1997
OSTEONICS ANTEVERTED NECK HIP STEM
K971497 · Osteonics Corp. · Jul 1997