# K221947: Tyber Medical Staple Fixation System (various)

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Oct 20, 2022 after 107 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902307 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc, Biomedical Enterprises, Inc. (2014) Summary page 4.
- K061798: Biopro Memory Staple, Biopro, Inc. (2006) Summary page 4.
- K072298: Biopro Memory Staple, Models 18062-18073, Biopro, Inc. (2007). Our OCR of the scanned summary read K077298, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioPro Memory Staple”.
- K150125: Elite Nitinol Fixation System, Biomedical Enterprises, Inc. (2015) Summary page 4.

## Indications for use
The Tyber Medical Staple System is indicated for: Fracture and osteotomy fixation, joint arthrodesis hand and foot. Fixation of proximal tibial metaphysis osteotomy. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. Fixation of small bone fragments (i.e., small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis and scapula.

Source page: https://510kreport.com/device/K221947
Methodology: https://510kreport.com/methodology