# K060746: Memory Staple

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 25, 2006 after 66 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: 1 generation back to K964226 (1997). 1 ancestor in all.
59 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964226: Memory Staple (20 Sizes Available), Landos, Inc. (1997) Summary page 1.

## 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
Memory 12 and Memory 20 staples are implants intended for fixation of the foot. Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint. The patient's anatomy and skeleton must be capable of receiving the selected implant.

Source page: https://510kreport.com/device/K060746
Methodology: https://510kreport.com/methodology