Cleared Traditional

MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM (K130084) - FDA 510(k) Clearance

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

K130084 · Tgm Medical, Inc. · Orthopedic device
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May 2013
Decision
109d
Days
Class 2
Risk

K130084 is an FDA 510(k) clearance for the MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, .... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Tgm Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on May 3, 2013 after a review of 109 days - within the typical 510(k) review window.

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 Tgm Medical, Inc. devices

Submission Details

510(k) Number K130084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2013
Decision Date May 03, 2013
Days to Decision 109 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 122d · This submission: 109d
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 517
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K130084.
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