Pipeline Total Hip System (Line Extension)

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

510(k) Number

K130353 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Neo Cr Knee System

  Class II

  FDA 510(k) K120313 Active Cleared 20 Apr 2012

• Pipeline Total Hip System

  Class II

  FDA 510(k) K112802 Active Cleared 9 Mar 2012

• Pipeline Cr Primary Knee System

  Class II

  FDA 510(k) K113122 Active Cleared 20 Mar 2012

• Pipeline Knee System

  Class II

  FDA 510(k) K132046 Active Cleared 23 Sep 2013

• NEO PS Knee System

  Class II

  FDA 510(k) K122500 Active Cleared 3 May 2013

• Neo Knee System

  Class II

  FDA 510(k) K131368 Active Cleared 3 Oct 2013

See all devices from Pipeline Orthopedics →

• What is the Pipeline Total Hip System used for?

  The Pipeline Total Hip System is a prosthetic device used for total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. It includes a femoral stem with tantalum beads for radiostereometric analysis of implant migration and acetabular screw hole occluders.

• What sizes are available for the Pipeline Total Hip System?

  The Pipeline Total Hip System is supplied in various sizes, including a size 1 femoral stem that was added in this line extension. This allows surgeons to select the appropriate size for each patient's specific anatomy.

• What regulatory status does the Pipeline Total Hip System have?

  The Pipeline Total Hip System has received FDA 510(k) clearance as substantially equivalent under product code LPH. This means it has been determined to be as safe and effective as a legally marketed device.

• How is the Pipeline Total Hip System supplied?

  The Pipeline Total Hip System is supplied as a prosthetic device for total hip arthroplasty, including a femoral stem with tantalum beads and acetabular screw hole occluders. It is intended for use by orthopedic surgeons in clinical settings.