Cleared Traditional

PSK FEMORAL AND TIBIAL INSERT COMPONENT (K920426) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920426 · Orthomet, Inc. · Orthopedic device
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Aug 1992
Decision
182d
Days
Class 2
Risk

K920426 is an FDA 510(k) clearance for the PSK FEMORAL AND TIBIAL INSERT COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 3, 1992 after a review of 182 days - an extended review 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: 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 Orthomet, Inc. devices

Submission Details

510(k) Number K920426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1992
Decision Date August 03, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 122d · This submission: 182d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K920426.
AGC AND MAXIM KNEE COMPONENTS WITH NTS
K922285 · Biomet, Inc. · Aug 1992
7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA
K922104 · Osteonics Corp. · Aug 1992
AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE
K910992 · Depuy, Inc. · Aug 1992
OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM
K914565 · Osteonics Corp. · May 1992
OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION
K920524 · Osteonics Corp. · May 1992
7000 SERIES TOTAL KNEE PATELLAR COMPONENTS
K915186 · Osteonics Corp. · Feb 1992