K3 Bone Screw System

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

510(k) Number

K960533 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SN

• Kmi Wrist Fusion System

  Class II

  FDA 510(k) K991873 Active Cleared 17 Aug 1999

• Kmi Cement Restrictor Implant

  Class II

  FDA 510(k) K061465 Active Cleared 5 Oct 2006

• K4 Bone Screw System

  Class II

  FDA 510(k) K950704 Active Cleared 30 Jun 1995

• Kompressor Screw System

  Class II

  FDA 510(k) K040356 Active Cleared 1 Mar 2004

• K2 Bone Screw System

  Class II

  FDA 510(k) K960537 Active Cleared 25 Mar 1996

• Diao Hand Surgery Set

  Class I

  FDA 510(k) K960539 Active Cleared 23 Jul 1996

See all devices from Kinetikos Medical, Inc. →

• What types of fractures is the K3 Bone Screw System specifically designed to stabilize, and how does it differ from larger orthopedic fixation devices?

  The K3 Bone Screw System is engineered for precise internal fixation of small bones in the hand or mid/forefoot fractures. Unlike larger orthopedic devices, it is tailored for delicate, smaller bone structures where stability and minimal invasiveness are critical. Its design ensures secure fixation in these specific areas, reducing the risk of complications often associated with oversized hardware in smaller bones.

• Is the K3 Bone Screw System intended for reuse in clinical settings, or is it meant to be used only once per patient?

  The K3 Bone Screw System is explicitly supplied sterile and intended for single-use only. This design choice aligns with best practices for infection control and patient safety, ensuring each patient receives a sterile, uncontaminated device. Reuse is not recommended or supported by the manufacturer.

• How is the K3 Bone Screw System regulated by the FDA, and what does the clearance decision mean for its use in clinical practice?

  The K3 Bone Screw System was cleared through the FDA’s Traditional 510(k) pathway under the Orthopedic Advisory Committee in 1996. The clearance decision (dated March 25, 1996) confirms it is substantially equivalent for *some indications* to a legally marketed predicate device, meaning it meets FDA standards for safety and effectiveness in its designated applications. Clinicians may rely on this clearance when using it for hand or mid/forefoot fractures as described in the device labeling.

• What storage requirements should be followed for the K3 Bone Screw System to maintain its sterility and performance?

  While the exact storage instructions aren’t detailed in the provided data, the system is supplied sterile, so it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility is preserved until use, as single-use orthopedic devices require contamination-free conditions to prevent surgical site infections.