Skip to content

iNSitu Bipolar Hip System

by Theken Companies, LLC

510(k) K191297

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K191297; other models may be affected

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 NumberK191297 Date17 Sep 2019ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0227-2026 FDA Class II initiated 11 Sep 2025 on shared 510(k) K191297

    Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
KWY
Device Class
Class II
Regulation
21 CFR Part 888.3390
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Theken Companies, LLC