Encore Linear Porous Coated Hip

• • Terminated Z-2242-2016 FDA Class II ·initiated 21 Jun 2016

  Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.

510(k) Number

K974294 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →

• What types of hip joint issues is this device designed to address and how does it work within the body?

  The Encore Linear Porous Coated Hip Stem is designed to replace a damaged or diseased hip joint by acting as a cementless, uncemented prosthesis in the femur. Its porous coating encourages osseointegration—meaning it bonds directly with the bone over time—providing long-term stability. The semi-constrained design limits movement (translation and rotation) at the joint, improving biomechanical function while reducing wear and loosening risks compared to fully constrained implants.

• Is this device intended for single-use or can it be reused in multiple surgeries, and how should it be handled?

  This device is reusable within its intended surgical context, meaning it can be used in multiple procedures as long as sterile protocols are maintained. Since it is supplied sterile for surgical use, it must be handled under strict aseptic conditions—similar to other reusable orthopedic implants—to prevent contamination between cases. Reuse requires adherence to manufacturer guidelines for cleaning, sterilization, and inspection.

• What sizes or models are available for the Encore Linear Porous Coated Hip Stem, and how is it supplied?

  The device is supplied sterile for surgical use, but specific sizes or models aren’t detailed in the provided data. Typically, uncemented hip stems come in a range of femoral diameters and lengths to accommodate different patient anatomies. For exact sizing options, refer to the manufacturer’s surgical technique guide or contact Encore Orthopedics directly, as these details are critical for preoperative planning.

• Are there any special storage requirements for this device before surgery?

  While the data doesn’t specify exact storage conditions, all sterile surgical implants—including this reusable hip stem—require protection from contamination. It should be stored in a clean, dry environment, sealed in its original packaging or sterile barrier, and away from sources of moisture, dust, or direct sunlight. Follow the manufacturer’s instructions for packaging integrity and expiration checks before use.

• How was this device’s regulatory pathway determined, and what does that mean for its use in clinical practice?

  The Encore Linear Porous Coated Hip Stem was cleared via the FDA’s 510(k) pathway (K974294) in 1998, with a decision classification of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it had the same intended use and technological characteristics as a previously approved hip stem, ensuring it meets safety and effectiveness standards for cementless, uncemented hip replacements. Clinically, this clearance supports its use in standard orthopedic practices for patients requiring hip arthroplasty.