Cleared Traditional

OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES (K946234) - FDA 510(k) Clearance

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

K946234 · Osteonics Corp. · Orthopedic device
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Apr 1995
Decision
109d
Days
Class 2
Risk

K946234 is an FDA 510(k) clearance for the OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM 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 April 10, 1995 after a review of 109 days - within the typical 510(k) review window.

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 K946234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date April 10, 1995
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 K946234.
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
K941366 · Osteonics Corp. · Jun 1995
DEPUY CDH PROSTHESIS
K945844 · Depuy, Inc. · May 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K944836 · 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
RESTORATION HA ACETABULAR CUP SERIES
K943957 · Osteonics Corp. · Mar 1995