Cleared Traditional

K904170 - PCA TIBIAL BONE WEDGES

K904170 is the FDA 510(k) clearance for PCA TIBIAL BONE WEDGES by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K904170 · Howmedica Corp. · Orthopedic device
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Oct 1990
Decision
36d
Days
Class 2
Risk

K904170 is an FDA 510(k) clearance for the PCA (R) TIBIAL BONE WEDGES. 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 October 17, 1990 after a review of 36 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 K904170 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 11, 1990
Decision Date October 17, 1990
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
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 K904170.
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K904205 · Depuy, Inc. · Oct 1990
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K901085 · Intermedics Orthopedics · Sep 1990
NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)
K902335 · Intermedics Orthopedics · Aug 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · Depuy, Inc. · Aug 1990