Cleared Traditional

K122883 - EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM

K122883 is an FDA 510(k) clearance for EXP TIBIAL INSERTS AND PATELLAR COMPONE..., manufactured by Stelkast Company. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K122883 · Stelkast Company · Orthopedic device
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Aug 2013
Decision
319d
Days
Class 2
Risk

K122883 is an FDA 510(k) clearance for the EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Stelkast Company (Mcmurray, US). The FDA issued a Cleared decision on August 5, 2013 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Stelkast Company devices

FDA 510(k) Submission Details - K122883

510(k) Number K122883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2012
Decision Date August 05, 2013
Days to Decision 319 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
197d slower than avg
Panel avg: 122d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 891
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K122883.
NOVOKNEE TOTAL KNEE SYSTEM
K131398 · Novosource, Inc. · Sep 2013
CAS PSI KNEE SYSTEM
K131409 · Orthosoft, Inc. · Sep 2013
GMK FULL PE TIBIAL COMPONENTS
K131310 · Medacta International · Aug 2013
GMK REVISION EXTENSION
K123721 · Medacta International · Jul 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K131467 · Conformis, Inc. · Jul 2013
PIPELINE KNEE SYSTEM
K123692 · Pipeline Orthopedics · May 2013