Conserve Thin Shell

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K113322 ↗

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 patients is the Conserve Thin Shell designed to support, and how does it address their needs?

  The Conserve Thin Shell is specifically designed for patients with degenerative joint conditions such as osteoarthritis, avascular necrosis, or hip dysplasia. It replaces the damaged acetabulum in the pelvis, providing structural support to stabilize the hip joint and restore function. Its semi-constrained, uncemented metal design ensures long-term stability without the need for bone cement, making it suitable for patients requiring cementless total hip arthroplasty.

• Is the Conserve Thin Shell reusable or single-use, and how should it be handled in the operating room?

  The Conserve Thin Shell is a reusable surgical implant intended for use in sterile operating environments. Since it is reusable, it must be thoroughly cleaned, sterilized, and inspected between procedures to maintain its integrity and prevent contamination. Proper handling, including adherence to sterile protocols, is critical to ensure its safety and effectiveness during orthopedic procedures.

• What size options are available for the Conserve Thin Shell, and how does this accommodate different patients?

  The Conserve Thin Shell comes in multiple sizes and variants to accommodate varying anatomical requirements. The exact dimensions or specific models are not listed in the provided data, but the availability of diverse sizes ensures that surgeons can select the most appropriate fit for each patient’s pelvic anatomy, optimizing stability and function during total hip arthroplasty.

• How is the Conserve Thin Shell regulated, and what does its FDA clearance indicate about its safety and performance?

  The Conserve Thin Shell has received FDA 510(k) clearance under product code KWA, which means it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance indicates that the device meets regulatory standards for safety and effectiveness as a Class III medical device, though it does not imply approval for specific clinical outcomes or indications beyond those described in its intended use.

• What steps should be taken to ensure the device remains effective between uses, given it is reusable?

  Since the Conserve Thin Shell is reusable, it must undergo rigorous cleaning, sterilization, and quality assurance processes between procedures. The manufacturer’s instructions (not provided here) should outline specific protocols, but generally, this includes high-level disinfection or sterilization (e.g., autoclaving or ethylene oxide), followed by thorough inspection for damage or wear. Proper storage in a clean, dry environment and adherence to sterile handling procedures are essential to maintain its performance and safety.