Osteonics FX-Cablelok Grip Components

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K980594 ↗

FDA Product Code

LYT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →

• What is the Osteonics FX-Cablelok Grip Component used for?

  The Osteonics FX-Cablelok Grip Components are fixation accessories designed to secure the greater trochanter following an osteotomy. They are intended for use in total hip replacement arthroplasty, surface replacement arthroplasty, or any hip procedure that requires a trochanteric osteotomy.

• How is the device supplied?

  The Osteonics FX-Cablelok Grip Components are supplied as part of the Osteonics FX-Cablelok System. They are intended for use with the system's cable and sleeve components.

• Is the device intended for single use or reuse?

  The device is not specified as single-use or reusable in the provided data. The intended use and regulatory status are defined by the Osteonics FX-Cablelok System.

• What is the regulatory status of the device?

  The Osteonics FX-Cablelok Grip Components are regulated under FDA 510(k) clearance. They are classified as a Class II medical device.