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Trabecular Metal Bone Stabilization Implant, Model 99-11197-XX-10

by Zimmer Trabecular 510(k)

Active United States

510(k) K050101

Overview

The Trabecular Metal Bone Stabilization Implant is a porous tantalum rod designed to provide structural support to the femoral head in patients with early-stage osteonecrosis. The device is cylindrical with a 10 mm diameter and lengths ranging from 70-130 mm, featuring distal threads with a 14 mm outer diameter for bone engagement.

This implant is surgically placed to support weakened bone and may be used with or without additional procedures. The device is supplied as a single-use implant and requires proper storage conditions. It has received FDA 510(k) clearance with the product code HRS and is classified under the orthopedic advisory committee.

AI-generated from registry data, 26 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 NumberK050101 Date15 Apr 2005ClearedStatusActive

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
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
The Trabecular Metal Bone Stabilization Implant, Model 99-11197-Xx-10
510(k) Number
FDA Product Code
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Trabecular Metal Bone Stabilization Implant used for?

    The Trabecular Metal Bone Stabilization Implant is a porous tantalum rod designed to provide structural support to the femoral head in patients with early-stage osteonecrosis. It helps support weakened bone and may be used with or without additional procedures.

  • What are the specifications and available sizes of this implant?

    The device is cylindrical with a 10 mm diameter and lengths ranging from 70-130 mm. It features distal threads with a 14 mm outer diameter for bone engagement. The implant is supplied as a single-use device and requires proper storage conditions.

  • What is the regulatory status of the Trabecular Metal Bone Stabilization Implant?

    The implant has received FDA 510(k) clearance with the product code HRS and is classified under the orthopedic advisory committee. It was determined to be substantially equivalent to predicate devices through the traditional clearance pathway.

  • How is the Trabecular Metal Bone Stabilization Implant supplied?

    The device is supplied as a single-use implant, meaning it is designed for one surgical procedure only and should not be reused. Proper storage conditions must be maintained to preserve the integrity of the implant before use.