Cleared Traditional

K872528 - OMNIFIT DISTAL STEM CEMENT SPACERS

K872528 is an FDA 510(k) clearance for OMNIFIT DISTAL STEM CEMENT SPACERS, 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 187-day FDA review.

K872528 · Osteonics Corp. · Orthopedic device
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Dec 1987
Decision
187d
Days
Class 2
Risk

K872528 is an FDA 510(k) clearance for the OMNIFIT DISTAL STEM CEMENT SPACERS. 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 December 29, 1987 after a review of 187 days - an extended review cycle.

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 - K872528

510(k) Number K872528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1987
Decision Date December 29, 1987
Days to Decision 187 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
65d slower than avg
Panel avg: 122d · This submission: 187d
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 K872528.
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
K904746 · Joint Medical Products Corp. · Nov 1990
OSTEONICS CEMENT RESTRICTOR
K900462 · Osteonics Corp. · Mar 1990
PT DISTAL TIP CEMENT SPACER
K894708 · Osteonics Corp. · Oct 1989
DOSIMETRY RELEASE OF RADIATION STERILIZ
K831512 · Biomet, Inc. · Sep 1983
BARD INTRAMEDULLARY PLUG
K831128 · C.R. Bard, Inc. · Jul 1983