Cleared Traditional

PROVEN KNEE SYSTEM (K000113) - FDA 510(k) Clearance

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

K000113 · Stelkast Company · Orthopedic device
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Apr 2000
Decision
81d
Days
Class 2
Risk

K000113 is an FDA 510(k) clearance for the PROVEN KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on April 4, 2000 after a review of 81 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 Stelkast Company devices

Submission Details

510(k) Number K000113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2000
Decision Date April 04, 2000
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 K000113.
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · Biomet, Inc. · Sep 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978 · Biomet, Inc. · Jun 2000
ASCENT KNEE REVISION FEMORAL STEM
K001010 · Biomet, Inc. · Apr 2000
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
K000091 · Howmedica Osteonics Corp. · Mar 2000
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
K994128 · Howmedica Osteonics Corp. · Mar 2000
SADDLE SHAPED PATELLA
K993371 · Wrightmedicaltechnologyinc · Dec 1999