Cleared Traditional

OSTEONICS OMNIFIT AD-HA HIP STEM SERIES (K941366) - FDA 510(k) Clearance

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

K941366 · Osteonics Corp. · Orthopedic device
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Jun 1995
Decision
442d
Days
Class 2
Risk

K941366 is an FDA 510(k) clearance for the OSTEONICS OMNIFIT AD-HA 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 June 6, 1995 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Osteonics Corp. devices

Submission Details

510(k) Number K941366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date June 06, 1995
Days to Decision 442 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
320d slower than avg
Panel avg: 122d · This submission: 442d
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 K941366.
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
K951671 · Osteonics Corp. · Sep 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K951932 · Osteonics Corp. · Sep 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K951291 · Osteonics Corp. · Aug 1995
DEPUY CDH PROSTHESIS
K945844 · Depuy, Inc. · May 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K944836 · Osteonics Corp. · Apr 1995
OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
K946234 · Osteonics Corp. · Apr 1995