Cleared Traditional

K970957 - OSTEONICS RESTORATION ACETABULAR RING

K970957 is the FDA 510(k) clearance for OSTEONICS RESTORATION ACETABULAR RING by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDJ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K970957 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
78d
Days
Class 2
Risk

K970957 is an FDA 510(k) clearance for the OSTEONICS RESTORATION ACETABULAR RING. Classified as Mesh, Surgical, Acetabular, Hip, Prosthesis (product code JDJ), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on June 3, 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 878.3300 - 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 K970957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date June 03, 1997
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis

Devices cleared under the same product code (JDJ) and FDA review panel - the closest regulatory comparables to K970957.
EXETER MESH
K963940 · Howmedica, Inc. · Feb 1997
REFLECTION ACETABULAR REINFORCEMENT RINGS
K962541 · Smith & Nephew Richards, Inc. · Sep 1996
PROTRUSION CAGES
K962007 · Depuy, Inc. · Aug 1996
OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS
K925883 · Osteonics Corp. · Jun 1993
INTERMEDICS APR(TM) II FEMORAL COMPONENT
K890450 · Intermedics Orthopedics · Aug 1989