Cleared Traditional

K943957 - RESTORATION HA ACETABULAR CUP SERIES

K943957 is the FDA 510(k) clearance for RESTORATION HA ACETABULAR CUP SERIES by Osteonics Corp.. It is a Class 2 Orthopedic device (product code MEH) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K943957 · Osteonics Corp. · Orthopedic device
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Mar 1995
Decision
203d
Days
Class 2
Risk

K943957 is an FDA 510(k) clearance for the RESTORATION HA ACETABULAR CUP SERIES. 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 March 6, 1995 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonics Corp. devices

Submission Details

510(k) Number K943957 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 15, 1994
Decision Date March 06, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
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 132
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K943957.
OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
K946234 · Osteonics Corp. · Apr 1995
OSTEONICS(R) THREADED HA ACETABULAR SHELLS
K945691 · Osteonics Corp. · Mar 1995
OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM
K942900 · Osteonics Corp. · Mar 1995
SUMMIT TOTAL HIP SYSTEM
K942891 · Kirschner Medical Corp. · Nov 1994
TECHMEDICA CONTINUUM HIP WITH HA COATING
K932017 · Techmedica, Inc. · Sep 1994
F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
K935990 · Implex Corp. · Jul 1994