Link Dynamic Staple

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

510(k) Number

K853704 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Link Cortical Screws

  Class II

  FDA 510(k) K854827 Active Cleared 27 Dec 1985

• Link Contour Ribbed Hip Prostheses System

  Class II

  FDA 510(k) K854465 Active Cleared 10 Feb 1986

• Link Ceramic Heads 12/14 X 32mm

  Class II

  FDA 510(k) K931571 Active Cleared 19 Apr 1994

• Schwabe Radius Plates

  Class II

  FDA 510(k) K914803 Active Cleared 28 Apr 1992

• Radius Osteotomy Plates

  Class II

  FDA 510(k) K914804 Active Cleared 29 Apr 1992

• Feldmuhle Ceramic Head

  Class II

  FDA 510(k) K920756 Active Cleared 18 May 1992

See all devices from Link America, Inc. →

• What is the Link Dynamic Staple used for?

  The Link Dynamic Staple is designed for orthopedic applications to secure bone fragments or stabilize fractures. It applies controlled compression through dynamic fixation, allowing gradual tension adjustment as the bone heals. This promotes optimal alignment and stability, reducing the need for rigid internal fixation in certain surgical procedures.

• Is the Link Dynamic Staple single-use or reusable?

  The Link Dynamic Staple is intended for single-use only. It is supplied as a surgical tool meant to be used once by trained medical professionals in controlled settings, ensuring patient safety and sterility.

• How is the Link Dynamic Staple supplied and stored?

  The device is supplied as a single-use orthopedic fixation tool for surgical use. Storage must follow the manufacturer’s guidelines to maintain its integrity. While no specific sterility or MRI safety details are provided, standard aseptic techniques are required for orthopedic procedures involving this device.

• What regulatory pathway was followed for the Link Dynamic Staple?

  The Link Dynamic Staple received FDA 510K clearance (K853704) under the Traditional pathway in 1986, with a decision of Substantially Equivalent. It is classified under FDA regulation 888.3030 as a Staple, Fixation, Bone (JDR).

• Can the Link Dynamic Staple be adjusted during bone healing?

  Yes, the design of the Link Dynamic Staple allows for gradual adjustment of tension as the bone heals. This dynamic fixation helps maintain optimal alignment and stability without requiring rigid internal fixation, supporting the natural healing process.