Cleared Traditional

APR FEMORAL HIP COMPONENT (K930812) - FDA 510(k) Clearance

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

K930812 · Intermedics Orthopedics · Orthopedic device
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Nov 1993
Decision
273d
Days
Class 2
Risk

K930812 is an FDA 510(k) clearance for the APR FEMORAL HIP COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on November 17, 1993 after a review of 273 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 Intermedics Orthopedics devices

Submission Details

510(k) Number K930812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1993
Decision Date November 17, 1993
Days to Decision 273 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 122d · This submission: 273d
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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K930812.
APC FEMORAL COMPONENT
K926229 · Howmedica Corp. · Feb 1994
HOWMEDICA ACETABULAR SHELL
K930223 · Howmedica Corp. · Feb 1994
HOWMEDICA REVISION HIP SYSTEM
K930460 · Howmedica Corp. · Feb 1994
EXACTECH FEMORAL STEM
K925201 · Exactech, Inc. · Jun 1993
STABILITY HIP FEMORAL COMPONENT
K915594 · Depuy, Inc. · Apr 1993
DEPUY HIP PROSTHESIS
K914078 · Depuy, Inc. · Jan 1993