Corin Unipolar Modular Head

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

510(k) Number

K063791 ↗

FDA Product Code

KWL

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Corin USA →

• What types of orthopedic procedures is the Corin Unipolar Modular Head designed for, and how does its modularity benefit the surgeon?

  The Corin Unipolar Modular Head is designed for use in cemented and uncemented primary or revision hemi-arthroplasty procedures, replacing a diseased or injured femoral head. Its modular design allows intraoperative adjustments to match the patient’s anatomy, ensuring a precise fit with various femoral stem systems. This flexibility enhances surgical adaptability, particularly in complex cases where anatomical variations require customization.

• What materials are used in the construction of the Corin Unipolar Modular Head, and why are these materials chosen?

  The device’s outer surface is constructed from metal alloys, specifically cobalt-chrome (Co-Cr), titanium (Ti), or stainless steel. These materials are selected for their structural integrity, durability, and biocompatibility, ensuring long-term performance and resistance to wear or corrosion in the body.

• Is the Corin Unipolar Modular Head intended for single-use or reusable applications, and how should it be handled?

  The Corin Unipolar Modular Head is supplied as a single-use, sterile implant and must be handled under aseptic conditions in an operating room setting. This ensures patient safety by preventing contamination and maintaining sterility before implantation.

• What regulatory clearance does the Corin Unipolar Modular Head hold, and what does this mean for its use in clinical settings?

  The device holds FDA 510(k) clearance (K063791), confirming it is substantially equivalent to predicate devices under the traditional review pathway. This clearance indicates it meets FDA standards for safety and effectiveness, allowing its use in approved orthopedic procedures as described in the labeling.

• Are there any special considerations for storage or MRI safety with the Corin Unipolar Modular Head?

  The manufacturer recommends adhering to general guidelines for metallic implants during storage, though no specific MRI safety information is provided. Since it contains metal alloys, caution should be exercised if MRI is considered post-implantation, as metallic components may interact with magnetic fields.