Cleared Traditional

K933875 - PREMISE CEMENTED FEMORAL STEM

K933875 is the FDA 510(k) clearance for PREMISE CEMENTED FEMORAL STEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K933875 · Howmedica Corp. · Orthopedic device
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Mar 1994
Decision
204d
Days
Class 2
Risk

K933875 is an FDA 510(k) clearance for the PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 204 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 Howmedica Corp. devices

Submission Details

510(k) Number K933875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1993
Decision Date March 01, 1994
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 435
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K933875.
RMHS POROUS DISTAL SLEEVE
K932574 · Smith & Nephew Richards, Inc. · Mar 1994
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
K933561 · Osteonics Corp. · Mar 1994
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
K930187 · Osteonics Corp. · Mar 1994
PRECISION OSTEOFLEX FEMORAL COMPONENT
K903630 · Howmedica Corp. · Feb 1994
APC FEMORAL COMPONENT
K926229 · Howmedica Corp. · Feb 1994
HOWMEDICA ACETABULAR SHELL
K930223 · Howmedica Corp. · Feb 1994