Altra Press-Fit Hip System

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

510(k) Number

K063002 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of hip surgeries is the Altra Press-Fit Hip System designed for, and why is it considered semi-constrained?

  The Altra Press-Fit Hip System is designed for hip arthroplasty procedures where damaged or diseased hip joints need replacement to restore mobility and function. It is classified as semi-constrained because its acetabular component allows for some rotational movement while still providing stability within the pelvis, reducing the risk of dislocation compared to fully unconstrained designs. This design is ideal for patients requiring a balance between stability and natural joint motion.

• How is the Altra Press-Fit Hip System supplied, and what precautions should be taken to maintain its sterility?

  The Altra Press-Fit Hip System is supplied as a sterile, single-use device, meaning it is intended for one surgical procedure only. To maintain sterility and integrity before use, it must be handled according to the manufacturer’s guidelines, which likely include keeping the packaging sealed until immediately before surgery and avoiding contamination from environmental factors like moisture or direct contact with unsterile surfaces.

• Does the Altra Press-Fit Hip System come in multiple sizes, and how would a surgeon determine the correct size for a patient?

  Yes, the system includes multiple component sizes, as indicated by the listed FEI numbers (e.g., 3020282716, 3007923096). The correct size is determined through preoperative planning, typically using imaging studies like X-rays or CT scans to assess the patient’s pelvic anatomy. This ensures proper fit and fixation, optimizing stability and reducing the risk of complications during hip replacement.

• Is the Altra Press-Fit Hip System intended for use with bone cement, and why is this an important consideration?

  No, the Altra Press-Fit Hip System is explicitly designed as an uncemented acetabular component, meaning it is intended to be press-fit into the pelvis without the use of bone cement. This design relies on the natural bone ingrowth and fixation properties of the component to achieve long-term stability, which can be particularly advantageous for younger or more active patients who may have longer life expectancies with their implant.

• What regulatory pathway was followed for the FDA clearance of the Altra Press-Fit Hip System, and what does this mean for clinicians?

  The Altra Press-Fit Hip System received FDA 510(k) clearance under a Special 510(k) pathway, with a decision code of SESE (Substantially Equivalent, Special). This means the device was determined to be substantially equivalent to a legally marketed predicate device (a previously approved hip prosthesis) in terms of technology, performance, and intended use. For clinicians, this clearance indicates that the device meets FDA standards for safety and effectiveness, though individual surgical techniques and patient selection remain critical factors in achieving successful outcomes.