Cleared Traditional

OSTEONICS ANTEVERTED NECK HIP STEM (K971497) - FDA 510(k) Clearance

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

K971497 · Osteonics Corp. · Orthopedic device
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Jul 1997
Decision
83d
Days
Class 2
Risk

K971497 is an FDA 510(k) clearance for the OSTEONICS ANTEVERTED NECK HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 16, 1997 after a review of 83 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 Osteonics Corp. devices

Submission Details

510(k) Number K971497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1997
Decision Date July 16, 1997
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 290
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K971497.
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 ALUMINA C-TAPER HEAD
K971409 · Osteonics Corp. · Jul 1997
RELIANCE PF FEMORAL STEMS
K970200 · Howmedica Corp. · Apr 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704 · Depuy, Inc. · Jan 1997