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TGS Unicompartmental Knee Arthroplasty System

by Alexandria Research Technologies, LLC

510(k) K090024

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090024 Date4 May 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HSX
Device Class
Class II
Regulation
21 CFR Part 888.3520
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TGS Unicompartmental Knee Arthroplasty System is a prosthesis for knee, femorotibial, non-constrained, cemented arthroplasty. It is indicated for unicompartmental knee replacement in patients with non-inflammatory degenerative joint disease, including post-traumatic arthritis and osteoarthritis.

The system is supplied as a modular tibia system and is intended for use in surgical settings. It is a reusable or single-use device as per manufacturer specifications, with sterility and MRI safety details not provided in the data. The device is authorized under FDA 510(k) clearance K090024 and K101206, with product code HSX, and is manufactured by Alexandria Research Technologies, LLC in Plymouth, MN.

Other devices from Alexandria Research Technologies, LLC

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TGS Unicompartmental Knee Arthroplasty System used for?

    It is indicated for unicompartmental knee replacement in patients with non-inflammatory degenerative joint disease, including osteoarthritis and post-traumatic arthritis, as a cemented, non-constrained femorotibial prosthesis.

  • How is the TGS Unicompartmental Knee Arthroplasty System supplied and is it reusable?

    The system is supplied as a modular tibia system intended for surgical use and may be configured as either reusable or single-use depending on manufacturer specifications, though specific reuse limits are not detailed in the provided data.

  • What regulatory authorization does the TGS Unicompartmental Knee Arthroplasty System have?

    The device is authorized under FDA 510(k) clearance with K numbers K090024 and K101206, classified under product code HSX, and was determined to be substantially equivalent to a predicate device.