Cleared Traditional

OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR (K923616) - FDA 510(k) Clearance

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

K923616 · Osteonics Corp. · Orthopedic device
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Oct 1992
Decision
101d
Days
Class 2
Risk

K923616 is an FDA 510(k) clearance for the OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on October 30, 1992 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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 K923616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date October 30, 1992
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDK Prosthesis, Hip, Cement Restrictor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - JDK Prosthesis, Hip, Cement Restrictor

All 11
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K923616.
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · Medtronic Sofamor Danek USA, Inc. · Oct 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · Medtronic Sofamor Danek USA, Inc. · Aug 2001
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
OSTEONICS(R) MID-SHAFT CEMENT SPACER
K910461 · Osteonics Corp. · Apr 1991
OSTEONICS CEMENT RESTRICTOR
K900462 · Osteonics Corp. · Mar 1990
PT DISTAL TIP CEMENT SPACER
K894708 · Osteonics Corp. · Oct 1989