Cleared Traditional

K936126 - HOWMEDICS DRG FEMORAL COMPONENT

K936126 is an FDA 510(k) clearance for HOWMEDICS DRG FEMORAL COMPONENT, manufactured by Howmedica, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 301-day FDA review.

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

FDA 510(k) Submission Details - K936126

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
Combination Product No
PCCP Authorized No
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.

JDI Device Classification - Class 2, Special Controls

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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K936126.
PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
K930771 · Orthomet, Inc. · Nov 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · Depuy, Inc. · Nov 1994
HOWMEDICA PREMIUM FEMORAL COMPONENT
K936127 · 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
APR ACETABULAR INSERT
K941617 · Intermedics Orthopedics · Oct 1994