Cleared Traditional

K970697 - OSTEONICS NORMALIZED AD ACETABULAR COMP...

K970697 is the FDA 510(k) clearance for OSTEONICS NORMALIZED AD ACETABULAR COMP... by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K970697 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
58d
Days
Class 2
Risk

K970697 is an FDA 510(k) clearance for the OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 24, 1997 after a review of 58 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 Osteonics Corp. devices

Submission Details

510(k) Number K970697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1997
Decision Date April 24, 1997
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K970697.
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
K971705 · Implex Corp. · Aug 1997
HEMISPHERE CEMENTED CUP
K971581 · Ortho Development Corp. · Jul 1997
DURATION STABILIZED UHMWPE
K963612 · Howmedica Corp. · Jun 1997
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
K970194 · Stelkast Company · Apr 1997
THE C-FIT FEMORAL HIP SYSTEM
K965019 · Corin USA · Mar 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · Johnson & Johnson Professionals, Inc. · Feb 1997