Uni-Clip Staple

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

510(k) Number

K991482 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Solustaple

  Class II

  FDA 510(k) K991566 Active Cleared 3 Aug 1999

• Modification to Ttc Plates

  Class II

  FDA 510(k) K070160 Active Cleared 8 Feb 2007

• Bold Screw

  Class II

  FDA 510(k) K990622 Active Cleared 29 Apr 1999

• The Uni-Clip Staple

  Class II

  FDA 510(k) K011716 Active Cleared 30 Aug 2001

• Kalix II Implant

  Class II

  FDA 510(k) K061765 Active Cleared 18 Jul 2006

• Spin Snap-Off Screw

  Class II

  FDA 510(k) K991477 Active Cleared 14 Jul 1999

See all devices from New Deal, S.A. →

• What types of orthopedic procedures is the Large Uni-Clip Staple intended for, and how does it work in those settings?

  The Large Uni-Clip Staple is designed for securing bone fragments or reconstructing bone structures during orthopedic surgery. It works by providing adjustable compression through a mechanical deformation mechanism—specifically, its diamond-shaped opening widens to narrow the space between its legs, allowing controlled compression when applied. This makes it useful in procedures where stable fixation of bone segments is required, such as fractures or reconstructive surgeries.

• Is the Large Uni-Clip Staple reusable, or is it meant for single-use only? How does this affect its storage and handling?

  The Large Uni-Clip Staple is explicitly intended for single-use only in orthopedic procedures. Because it is supplied sterile, storage and handling must follow strict sterile surgical instrument protocols to maintain its integrity and prevent contamination before use. Reuse is not recommended or supported by the manufacturer.

• What size options are available for the Large Uni-Clip Staple, and how do the measurements relate to its clinical application?

  The Large Uni-Clip Staple comes in four interaxis sizes (11 mm, 12 mm, 13 mm, and 15 mm) and four lengths (13 mm to 20 mm). The interaxis measurement refers to the distance between the staple’s legs when closed, which determines how tightly it can compress bone fragments. The length refers to the overall size of the staple, ensuring it fits the surgical site. These variations allow surgeons to select the appropriate size for the specific bone anatomy and compression needs.

• How is the sterility of the Large Uni-Clip Staple ensured, and what precautions should be taken during storage?

  The Large Uni-Clip Staple is supplied sterile to ensure safety for surgical use. To maintain sterility, it must be stored in accordance with standard sterile surgical instrument protocols—typically in sealed, sterile packaging until the time of use. Avoid exposure to moisture, contamination, or physical damage, as these could compromise its sterile condition.

• What regulatory pathway was followed for FDA clearance of the Large Uni-Clip Staple, and what does this mean for its use in clinical settings?

  The Large Uni-Clip Staple received FDA 510(k) clearance under the Traditional review pathway, classified as Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended purpose and technical characteristics as an existing cleared device, ensuring it meets regulatory standards for safety and effectiveness. Clinicians can rely on this clearance as evidence of its compliance with U.S. regulatory requirements for orthopedic fixation devices.