Total Hip Femoral Component

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

510(k) Number

K840150 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Freeman Hip

  Class II

  FDA 510(k) K852839 Active Cleared 29 Oct 1985

• Mark I Total Knee Sys. Arthroplasty

  Class II

  FDA 510(k) K832302 Active Cleared 16 Aug 1983

• Yasargil Fenestrated Aneurysm Clip &

  Class II

  FDA 510(k) K833652 Active Cleared 27 Jan 1984

• PM Cementless Screw-In Acetabular Cup

  Class III

  FDA 510(k) K850773 Active Cleared 2 May 1985

• Cls Hip Prosthesis

  Class II

  FDA 510(k) K852517 Active Cleared 18 Sep 1985

• Padgett Suction Cannula

  Class I

  FDA 510(k) K833717 Active Cleared 14 Dec 1983

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• What is the TOTAL HIP FEMORAL COMPONENT used for?

  It is implanted to replace a hip joint, limiting translation and rotation in one or more planes through the geometry of its articulating surfaces, with no linkage across the joint, to restore joint stability and function.

• How is the TOTAL HIP FEMORAL COMPONENT supplied and what is its regulatory pathway?

  It is supplied as a sterile, single-use implant for surgical implantation and was cleared through the FDA Traditional 510(k) pathway under K840150, demonstrating substantial equivalence to a predicate device.

• What classification and product code does the TOTAL HIP FEMORAL COMPONENT have?

  It is classified as a Class 2 orthopedic device with product code JDI, as indicated in its FDA 510(k) clearance documentation, which determines its regulatory controls and post-market requirements.