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InterSpace Knee Extra-Large Size, InterSpace Knee ATS

by Tecres S.p.A.

510(k) K181732

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 NumberK181732 Date27 Apr 2019ClearedStatusActive

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  • Withdrawn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
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The InterSpace Knee Extra-Large Size, InterSpace Knee ATS is a knee joint patellofemorotibial polymer semi-constrained device. It is indicated for temporary use (maximum 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, or as an adjunct to total knee replacement in such patients.

The device is supplied by Tecres S.p.A. and was cleared through the FDA 510(k) process under K-number K181732. It is intended for temporary implantation and is not designed for long-term use. No information regarding sterility, single-use or reusable status, MRI safety, storage conditions, or additional sizes is provided in the data.

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Questions

AI-generated answers, 21 Sep 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 InterSpace Knee Extra-Large Size ATS used for?

    It is indicated for temporary use (maximum 180 days) as a total knee replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process, or as an adjunct to total knee replacement in such patients. This is based on its intended use as a temporary implant to manage infection while preserving joint function during staged revision.

  • How is the InterSpace Knee Extra-Large Size ATS supplied and what is its intended duration of use?

    The device is supplied by Tecres S.p.A. and is intended for temporary implantation only, with a maximum use duration of 180 days. It is not designed for long-term use, as explicitly stated in the device description, to avoid complications from prolonged polymer implantation in infected fields.

  • What regulatory pathway was used for the InterSpace Knee Extra-Large Size ATS and what is its K-number?

    The device was cleared through the FDA 510(k) process under K-number K181732, as stated in the authorizations and specifications. This indicates it was found substantially equivalent to a predicate device, which is the basis for its market authorization in the U.S.