Cleared Traditional

OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM (K970394) - FDA 510(k) Clearance

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

K970394 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
78d
Days
Class 2
Risk

K970394 is an FDA 510(k) clearance for the OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on April 22, 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 Osteonics Corp. devices

Submission Details

510(k) Number K970394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date April 22, 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 MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 102
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K970394.
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
K982032 · Osteonics Corp. · Jul 1998
OSTEONICS ANTEVERTED NECK HA HIP STEMS
K980766 · Osteonics Corp. · May 1998
OSTEONICS ACETABULAR WEDGE SYSTEM
K971422 · Osteonics Corp. · May 1997
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
K963959 · Osteonics Corp. · Dec 1996
PCA +15MM MODULAR FEMORAL HEAD
K955305 · Howmedica Corp. · Jan 1996
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
K951517 · Osteonics Corp. · Jan 1996