Cleared Traditional

K964655 - UHMWPE HIP AND KNEE COMPONENTS - PACKAG...

K964655 is the FDA 510(k) clearance for UHMWPE HIP AND KNEE COMPONENTS - PACKAG... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K964655 · Howmedica Corp. · Orthopedic device
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Feb 1997
Decision
78d
Days
Class 2
Risk

K964655 is an FDA 510(k) clearance for the UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE. 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 February 6, 1997 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K964655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date February 06, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 122d · This submission: 78d
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 K964655.
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HEDROCEL ACETABULAR RESTRICTOR
K962468 · Implex Corp. · Feb 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K963671 · Osteonics Corp. · Feb 1997
MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
K964350 · Intermedics Orthopedics · Jan 1997