# K061594: Large Uni-Clip Staple

- Pathway: 510(k) (Special)
- Applicant: New Deal, S.A.
- Decided: Jul 3, 2006 after 25 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: 3 generations back to K964226 (1997). 7 ancestors in all.
103 later devices descend from it; 1 cites it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011716: The Uni-Clip Staple, New Deal, S.A. (2001) Summary page 2.

## Most influential descendants
- K070447: Newdeal Compression Plate (2007), 102 descendants of its own
- K093914: Newdeal Compression Plates (2011), 98 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own

## Indications for use
The LARGE UNI-CLIP® is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery - Fractures management in the foot or hand - Mono or Bi-cortical osteotomies in the foot or hand - Distal or proximal metatarsal or metacarpal osteotomies - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) The size and number of staple(s) used should be adapted to the specific indication.

Source page: https://510kreport.com/device/K061594
Methodology: https://510kreport.com/methodology