Cleared Traditional

OSTEONICS OMNIFIT FORGED HIP STEM SERIES (K933561) - FDA 510(k) Clearance

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

K933561 · Osteonics Corp. · Orthopedic device
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Mar 1994
Decision
230d
Days
Class 2
Risk

K933561 is an FDA 510(k) clearance for the OSTEONICS OMNIFIT FORGED 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 March 9, 1994 after a review of 230 days - an extended review 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: 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

Submission Details

510(k) Number K933561 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 22, 1993
Decision Date March 09, 1994
Days to Decision 230 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
108d slower than avg
Panel avg: 122d · This submission: 230d
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 K933561.
AML TRI-LOCK REPLACEMENT LINER SYSTEM
K943302 · Depuy, Inc. · Oct 1994
PRECISION OSTEOLOCK ACETABULAR COMPONENT
K930275 · Howmedica Corp. · Sep 1994
S.O.S. PROXIMAL FEMUR
K933281 · Wrightmedicaltechnologyinc · Jun 1994
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
K930187 · Osteonics Corp. · Mar 1994
PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
K933875 · Howmedica Corp. · Mar 1994
PRECISION OSTEOFLEX FEMORAL COMPONENT
K903630 · Howmedica Corp. · Feb 1994