Cleared Traditional

K944836 - OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES

K944836 is an FDA 510(k) clearance for OSTEONICS RESTORATION MONOLITHIC II HIP..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K944836 · Osteonics Corp. · Orthopedic device
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Apr 1995
Decision
192d
Days
Class 2
Risk

K944836 is an FDA 510(k) clearance for the OSTEONICS 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 192 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

FDA 510(k) Submission Details - K944836

510(k) Number K944836 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 30, 1994
Decision Date April 10, 1995
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K944836.
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K951291 · Osteonics Corp. · Aug 1995
OSTEONICS OMNIFIT AD-HA HIP STEM SERIES
K941366 · Osteonics Corp. · Jun 1995
DEPUY CDH PROSTHESIS
K945844 · Depuy, Inc. · May 1995
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