Cleared Traditional

K963612 - DURATION STABILIZED UHMWPE

K963612 is an FDA 510(k) clearance for DURATION STABILIZED UHMWPE, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K963612 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 1997
Decision
274d
Days
Class 2
Risk

K963612 is an FDA 510(k) clearance for the DURATION STABILIZED UHMWPE. 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 June 11, 1997 after a review of 274 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

FDA 510(k) Submission Details - K963612

510(k) Number K963612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1996
Decision Date June 11, 1997
Days to Decision 274 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
152d slower than avg
Panel avg: 122d · This submission: 274d
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 514
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K963612.
RECOVERY PROTRUSIO CAGE
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IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
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HEMISPHERE CEMENTED CUP
K971581 · Ortho Development Corp. · Jul 1997
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · Osteonics Corp. · Apr 1997
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
K970194 · Stelkast Company · Apr 1997
THE C-FIT FEMORAL HIP SYSTEM
K965019 · Corin USA · Mar 1997