Cleared Traditional

OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES (K913812) - FDA 510(k) Clearance

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

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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K913812.
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K911802 · Biomet, Inc. · Jan 1992
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · Biomet, Inc. · Dec 1991
PT II DISTAL CEMENT SPACER
K914406 · Osteonics Corp. · Dec 1991
MODULAR CALCAR REPLACEMENT
K913649 · Zimmer, Inc. · Nov 1991
UHMWP ACETABULAR COMPONENT
K912426 · Howmedica Corp. · Aug 1991
OSTEONICS(R) PRT HIP STEM SERIES
K911890 · Osteonics Corp. · Jul 1991