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Ortholoc Advantim Tibial Stem 5 Degree

by Dow Corning Wright 510(k)

Active United States

510(k) K930228

Overview

The Ortholoc Advantim Tibial Stem 5 Degree is a prosthesis for the knee, specifically classified as a patellofemorotibial, semi-constrained, cemented, and composed of polymer/metal/polymer materials. It is designed for use in knee arthroplasty procedures to provide structural support and alignment within the tibial component of a knee implant system.

This device is supplied as a single component intended for implantation in orthopedic surgical settings. It received FDA 510(k) clearance under K930228 on November 30, 1993, and is classified as a Class II device under regulation number 888.3560. The product code is JWH, and it was determined to be substantially equivalent to a legally marketed predicate device.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930228 Date30 Nov 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Ortholoc Advantim Tibial Stem 5 Degree used for?

    It is a prosthesis for the knee, specifically designed for use in knee arthroplasty procedures to provide structural support and alignment within the tibial component of a knee implant system, classified as patellofemorotibial and semi-constrained.

  • How is the Ortholoc Advantim Tibial Stem 5 Degree supplied and is it reusable?

    It is supplied as a single component intended for implantation in orthopedic surgical settings, indicating it is a single-use device meant for one-time implantation and not designed for reuse.

  • What materials is the Ortholoc Advantim Tibial Stem 5 Degree made from?

    It is composed of polymer/metal/polymer materials, as specified in its classification as a prosthesis made from these combined material types for use in knee arthroplasty.

  • What regulatory pathway was used for the Ortholoc Advantim Tibial Stem 5 Degree?

    It received FDA 510(k) clearance under K930228 on November 30, 1993, and was determined to be substantially equivalent to a legally marketed predicate device, following a traditional clearance pathway.