Cleared Traditional

K923616 - OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR

K923616 is an FDA 510(k) clearance for OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K923616 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K923616

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.

JDK Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K923616.
RABEA DEVICE, MODEL PXXXXXX
K990345 · Signus Medizintechnik GmbH · Jul 1999
OSTEONICS SCREW HOLE PLUGS
K965056 · Osteonics Corp. · Feb 1997
BONE CEMENT RESTRICTOR
K926216 · Biodynamic Technologies, Inc. · Mar 1994
LIMA CEMENT RESTRICTOR
K911338 · Turnkey Intergration USA, Inc. · Jun 1991
OSTEONICS(R) MID-SHAFT CEMENT SPACER
K910461 · Osteonics Corp. · Apr 1991
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
K904746 · Joint Medical Products Corp. · Nov 1990