Stryker Orthopaedics Hip Systems Labeling Update

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K233498 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Triathlon® Knee System

  Class II

  FDA 510(k) K261898 Active Cleared 6 Aug 2026

• Omnifit® 20° Series I Insert Open recall

  Class II

  FDA 510(k) K261624 Active Cleared 10 Jul 2026

• Stryker Orthopaedics Hip Systems Labeling Update

  Class II

  FDA 510(k) K240418 Active Cleared 12 Apr 2024

• UHR Bipolar Implants, Restoration GAP II Implants

  Class II

  FDA 510(k) K222632 Active Cleared 21 Oct 2022

• Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components Open recall

  Class II

  FDA 510(k) K172634 Active Cleared 16 Nov 2017

• Restoration Anatomic Shell

  Class II

  FDA 510(k) K210893 Active Cleared 22 Apr 2021

See all devices from Howmedica Osteonics Corp., Dba Stryker Orthopaedics →

• What is the purpose of the Stryker Orthopaedics Hip Systems Labeling Update?

  This labeling update applies to Stryker's modular hip system components including femoral stems, acetabular shells, liners, femoral heads, augments, screws, and fixation accessories. These devices provide structural support, joint articulation, or fixation for bone during primary or revision total or hemi-hip arthroplasty procedures.

• How is the Stryker Hip Systems Labeling Update supplied and used?

  The device is supplied as part of the Stryker Orthopaedics Hip Systems and is used in clinical settings by orthopedic surgeons during hip arthroplasty procedures. The components are designed to be implanted during surgical procedures to replace or repair damaged hip joints.

• What is the regulatory status of the Stryker Hip Systems Labeling Update?

  The device received FDA 510(k) clearance under K233498 with a substantially equivalent decision and traditional clearance type. It is classified under product code LPH and was manufactured by Howmedica Osteonics Corp., doing business as Stryker Orthopaedics, located in Mahwah, NJ.

• What components are included in the Stryker Orthopaedics Hip Systems?

  The systems comprise modular components including femoral stems, acetabular shells, liners, femoral heads, augments, screws, and fixation accessories such as cables and grips. These components work together to provide structural support and joint articulation in hip replacement surgeries.