Cleared Traditional

K936127 - HOWMEDICA PREMIUM FEMORAL COMPONENT

K936127 is the FDA 510(k) clearance for HOWMEDICA PREMIUM FEMORAL COMPONENT by Howmedica, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K936127 · Howmedica, Inc. · Orthopedic device
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Oct 1994
Decision
307d
Days
Class 2
Risk

K936127 is an FDA 510(k) clearance for the HOWMEDICA PREMIUM FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on October 26, 1994 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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, Inc. devices

Submission Details

510(k) Number K936127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date October 26, 1994
Days to Decision 307 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
185d slower than avg
Panel avg: 122d · This submission: 307d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K936127.
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K930771 · Orthomet, Inc. · Nov 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · Depuy, Inc. · Nov 1994
HOWMEDICS DRG FEMORAL COMPONENT
K936126 · Howmedica, Inc. · Oct 1994
AML TRILOCK REPLACEMENT LINER SYSTEM
K942966 · Depuy, Inc. · Oct 1994
AML TRI-LOCK REPLACEMENT LINER SYSTEM
K943302 · Depuy, Inc. · Oct 1994