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Modified Trochanter Cable Grip System

by Howmedica Corp.

510(k) K872224

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK872224 Date17 Aug 1987ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0645-2022 FDA Class II initiated 21 Dec 2021

    There is a potential for the outer Tyvek lid to de-bond from the sealed package.

    • Terminated Z-1821-2009 FDA Unclassified (pre-2012) initiated 18 Jun 2009

    Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

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  • Withdrawn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
KTT
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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