# K011716: The Uni-Clip Staple

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Aug 30, 2001 after 87 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964226 (1997). 6 ancestors in all.
117 later devices descend from it; 6 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991482: Uni-Clip Staple, New Deal, S.A. (1999) Summary page 2.
- K964226: Memory Staple (20 Sizes Available), Landos, Inc. (1997) Summary page 2.
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 2.
- K991962: Eis Dynamic Memory Staples System, Groupe Lepine (2000) Summary page 2.
- K895117: Hto Compressing Staple, Howmedica Corp. (1990) Summary page 2.
- (no number) Richards Fixation Staples (Smith and Nephew Richards): named in the summary without a submission number

## Most influential descendants
- 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
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own

## Recalls of this device
- Jan 25, 2017 · Class III · Z-1410-2017: The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.

## Indications for use
The “new” uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including: Arthrodesis in hand or foot surgery Mono or Bi-cortical osteotomies in the foot or hand Fracture management in the foot or hand Distal or proximal metatarsal or metacarpal osteotomies Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

Source page: https://510kreport.com/device/K011716
Methodology: https://510kreport.com/methodology