Cleared Traditional

MTS KNEE SYSTEM (K905613) - FDA 510(k) Clearance

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

K905613 · T & R Mfg., Inc. · Orthopedic device
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Jun 1991
Decision
192d
Days
Class 2
Risk

K905613 is an FDA 510(k) clearance for the MTS KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by T & R Mfg., Inc. (Red Rock, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 192 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 T & R Mfg., Inc. devices

Submission Details

510(k) Number K905613 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 14, 1990
Decision Date June 24, 1991
Days to Decision 192 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 122d · This submission: 192d
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 K905613.
AGC REVISION KNEE PROTHESIS
K912245 · Biomet, Inc. · Aug 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
K912147 · Osteonics Corp. · Aug 1991
MG II POROUS COBAL T-CHROME FEMORAL COMPONENT
K911572 · Zimmer, Inc. · Jul 1991
PCA MTK II TOTAL KNEE SYSTEM
K910235 · Howmedica Corp. · Jun 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
K910990 · Osteonics Corp. · Jun 1991
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
K910989 · Osteonics Corp. · Jun 1991