Cleared Traditional

K970758 - DURACON EXTRA-SMALL STABILIZER TIBIAL I...

K970758 is the FDA 510(k) clearance for DURACON EXTRA-SMALL STABILIZER TIBIAL I... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K970758 · Howmedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 1997
Decision
80d
Days
Class 2
Risk

K970758 is an FDA 510(k) clearance for the DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 K970758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date May 22, 1997
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 768
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K970758.
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NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
K970498 · Intermedics Orthopedics · Apr 1997
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KIRSCHNER KNEE MODIFIED
K961021 · Biomet, Inc. · Mar 1997