Cleared Traditional

FUTURA FEMORAL HIP STEM (K910093) - FDA 510(k) Clearance

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

K910093 · O'Tec Corp. · Orthopedic device
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Jul 1991
Decision
174d
Days
Class 2
Risk

K910093 is an FDA 510(k) clearance for the FUTURA FEMORAL HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by O'Tec Corp. (Memphis, US). The FDA issued a Cleared decision on July 1, 1991 after a review of 174 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 O'Tec Corp. devices

Submission Details

510(k) Number K910093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1991
Decision Date July 01, 1991
Days to Decision 174 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 122d · This submission: 174d
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 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K910093.
OSTEONICS(R) PRT HIP STEM SERIES
K911890 · Osteonics Corp. · Jul 1991
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)
K911718 · Biomet, Inc. · Jul 1991
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
K911685 · Biomet, Inc. · Jul 1991
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K911684 · Biomet, Inc. · Jun 1991
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
K910869 · Howmedica Corp. · May 1991
PS OMNIFIT NORMALIZED HIP STEM SERIES
K910662 · Osteonics Corp. · May 1991