Foundation Fracture Stem

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

510(k) Number

K973809 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

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 patients is the Foundation Fracture Stem intended for, and how does its design support its use?

  The Foundation Fracture Stem is designed for patients requiring total hip arthroplasty due to femoral head or neck damage, such as fractures or degenerative conditions. Its straight, press-fit intramedullary design (JDI classification) and trapezoidal proximal geometry provide stability within the femur, while the 132-degree neck/stem angle helps restore natural hip biomechanics. The wrought/forged Ti-6Al-4V alloy ensures durability, and the Morse taper allows modular head attachment for customization.

• Is the Foundation Fracture Stem reusable or single-use, and what sterilization requirements apply?

  The Foundation Fracture Stem is supplied as a single-use device and is non-sterile at the time of shipment. Hospitals must perform terminal sterilization in their sterile processing department before use, following standard orthopedic implant protocols. This ensures compliance with surgical sterility standards for hip arthroplasty.

• What materials is the Foundation Fracture Stem made from, and how does this affect its performance?

  The stem is constructed from wrought/forged Ti-6Al-4V alloy, a titanium-based material known for its strength-to-weight ratio and biocompatibility. This alloy provides structural integrity for load-bearing applications in the femur while minimizing corrosion or wear. The grit-blasted surface further enhances osseointegration and stability during implantation.

• Are there specific storage or handling instructions for the Foundation Fracture Stem before terminal sterilization?

  Since the device is non-sterile and intended for single-use, it must be stored in a clean, dry environment as per manufacturer guidelines until terminal sterilization. After sterilization, it should adhere to standard orthopedic implant handling protocols to prevent contamination. Always follow the facility’s sterile processing procedures, as improper storage could compromise surgical outcomes.

• How is the Foundation Fracture Stem’s regulatory pathway defined, and what does that mean for clinicians?

  The Foundation Fracture Stem holds FDA 510(k) clearance (K973809) under the Orthopedic Advisory Committee (OR), classified as substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as determined by the agency. Clinicians can rely on this clearance as evidence of regulatory review, though individual hospitals must still follow sterile processing and surgical protocols specific to their facility.