Cleared Traditional

HOWMEDICS DRG FEMORAL COMPONENT (K936126) - FDA 510(k) Clearance

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

K936126 · Howmedica, Inc. · Orthopedic device
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Oct 1994
Decision
301d
Days
Class 2
Risk

K936126 is an FDA 510(k) clearance for the HOWMEDICS DRG 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 20, 1994 after a review of 301 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 K936126 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 23, 1993
Decision Date October 20, 1994
Days to Decision 301 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 122d · This submission: 301d
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 K936126.
PARAMOUNT CEMENTED HIP STEM PROTHESIS
K942537 · Depuy, Inc. · Jan 1995
RESTORATION ACETABULAR CUP
K943549 · Osteonics Corp. · Dec 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · Depuy, Inc. · Nov 1994
AML TRILOCK REPLACEMENT LINER SYSTEM
K942966 · Depuy, Inc. · Oct 1994
AML TRI-LOCK REPLACEMENT LINER SYSTEM
K943302 · Depuy, Inc. · Oct 1994
PRECISION OSTEOLOCK ACETABULAR COMPONENT
K930275 · Howmedica Corp. · Sep 1994