Cleared Traditional

K090024 - TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM

K090024 is an FDA 510(k) clearance for TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY ..., manufactured by Alexandria Research Technologies, LLC. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K090024 · Alexandria Research Technologies, LLC · Orthopedic device
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May 2009
Decision
119d
Days
Class 2
Risk

K090024 is an FDA 510(k) clearance for the TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Alexandria Research Technologies, LLC (Plymouth, US). The FDA issued a Cleared decision on May 4, 2009 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 Alexandria Research Technologies, LLC devices

FDA 510(k) Submission Details - K090024

510(k) Number K090024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2009
Decision Date May 04, 2009
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 110
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K090024.
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