Cleared Traditional

K913812 - OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STE...

K913812 is the FDA 510(k) clearance for OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STE... by Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K913812 · Osteonics Corp. · Orthopedic device
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Nov 1991
Decision
88d
Days
Class 2
Risk

K913812 is an FDA 510(k) clearance for the OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Osteonics Corp. devices

Submission Details

510(k) Number K913812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date November 22, 1991
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K913812.
PT II DISTAL CEMENT SPACER
K914406 · Osteonics Corp. · Dec 1991
APR II HIP SYSTEM
K913634 · Intermedics Orthopedics · Dec 1991
INFINITY(TM) MICROTAPER HIP SYSTEM
K913874 · Dow Corning Wright · Nov 1991
MODULAR CALCAR REPLACEMENT
K913649 · Zimmer, Inc. · Nov 1991
HYBRID FIT TOTAL HIP SYSTEM
K913246 · Kirschner Medical Corp. · Oct 1991
NATURAL POROUS HIP SYSTEM
K913060 · Intermedics Orthopedics · Oct 1991