# K061798: Biopro Memory Staple

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Aug 21, 2006 after 56 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
No predicates in its family tree.
65 later devices descend from it; 4 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own
- K141784: Ortho Solutions Ultos Plating System (2014), 28 descendants of its own
- K131722: I.T.S. Extremity Fixation Systems (2013), 24 descendants of its own
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own

## Indications for use
1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones. 2. Fixation of soft tissue to bone such as anterior cruciate reconstruction

Source page: https://510kreport.com/device/K061798
Methodology: https://510kreport.com/methodology