Cleared Traditional

K904746 - S-ROM(TM) FEMORAL STEM CENTRALIZER/CEME...

K904746 is an FDA 510(k) clearance for S-ROM(TM) FEMORAL STEM CENTRALIZER/CEME..., manufactured by Joint Medical Products Corp.. The device is a Class 2 Orthopedic device with product code JDK cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K904746 · Joint Medical Products Corp. · Orthopedic device
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Nov 1990
Decision
33d
Days
Class 2
Risk

K904746 is an FDA 510(k) clearance for the S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER. Classified as Prosthesis, Hip, Cement Restrictor (product code JDK), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 33 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Joint Medical Products Corp. devices

FDA 510(k) Submission Details - K904746

510(k) Number K904746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1990
Decision Date November 20, 1990
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
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 34
Devices cleared under the same product code (JDK) and FDA review panel - the closest regulatory comparables to K904746.
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
K923616 · Osteonics Corp. · Oct 1992
LIMA CEMENT RESTRICTOR
K911338 · Turnkey Intergration USA, Inc. · Jun 1991
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
OMNIFIT DISTAL STEM CEMENT SPACERS
K872528 · Osteonics Corp. · Dec 1987