Threaded Pins

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K920188 ↗

FDA Product Code

MBJ

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Dosimetric Release of Gamma Radiation

  Class II

  FDA 510(k) K832211 Active Cleared 29 Sep 1983

• Austin Moore Hip Prosthesis

  Not classified

  FDA 510(k) K863896 Active Cleared 19 Nov 1986

• Dimension Total Hip Prosthesis

  Class II

  FDA 510(k) K853333 Active Cleared 3 Sep 1985

• Compression System

  Class II

  FDA 510(k) K831076 Active Cleared 28 Apr 1983

• Wire & Steinman Pins

  Class II

  FDA 510(k) K831005 Active Cleared 18 May 1983

• Kirschner(R) Modular II-C(Tm) Total Shoulder System

  Class II

  FDA 510(k) K940537 Active Cleared 29 Aug 1995

See all devices from Kirschner Medical Corp. →

• Are these threaded pins meant for use in both internal and external bone fixation, or are they limited to a specific type of procedure?

  These threaded pins are designed specifically for internal bone fixation, providing stabilization for fractures or surgical repairs by securing bone fragments together. They are intended for use within an operating room environment during orthopedic procedures, where internal fixation is required. The biodegradable material resorbs naturally over time, allowing the bone to heal without the need for long-term hardware removal.

• How are the threaded pins packaged and prepared for use in the operating room?

  The threaded pins are supplied sterile in single-use packaging, ensuring they meet surgical standards for contamination control. This packaging is designed to maintain sterility until opened in the operating room, where they can be directly used for internal fixation procedures without additional sterilization.

• Are these pins reusable, or are they intended for one-time use only?

  These threaded pins are single-use only, as specified by their sterile packaging and classification as a Class III medical device. Reuse is not recommended or supported, as it could compromise sterility and patient safety. Each pin is intended for one surgical procedure before disposal.

• What sizes and threading specifications are available for these pins, and how do they ensure compatibility with surgical instruments?

  The threaded pins come in standardized sizes and threading specifications to ensure compatibility with common orthopedic surgical instruments and fixation systems. While exact dimensions are not provided here, the design adheres to industry norms for internal fixation hardware, allowing for precise placement and secure fixation of bone fragments during orthopedic procedures.