# K991482: Uni-Clip Staple

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Jun 3, 1999 after 36 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.
119 later devices descend from it; 2 cite it directly.
0 of 121 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 2.

## Most influential descendants
- K011716: The Uni-Clip Staple (2001), 117 descendants of its own
- K061594: Large Uni-Clip Staple (2006), 103 descendants of its own
- 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

## Indications for use
Mono or bi-cortical osteotomies in the forefoot Distal or proximal metatarsal osteotomies Fusion of the first metatarsophalongeal joint and the interphalangeal joint Fixation of the osteotomies for hallux valgus treatment (such as, Scarf, Chevron) Akyn type Osteotomy Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus Arthrodesis and osteotomy fixation in the Midfoot and Hindfoot

Source page: https://510kreport.com/device/K991482
Methodology: https://510kreport.com/methodology