# K991566: Solustaple

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Aug 3, 1999 after 90 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Depuy, Inc. Varisation Staple: named in the summary without a submission number

## Most influential descendants
- K143323: OS2-V Varisation Staple (2015), 5 descendants of its own
- K153770: OS2(R)-VP Varisation Staple (2016), 4 descendants of its own
- K233302: OSSIOfiber® Compression Staple (2023), 1 descendant of its own
- K170688: PIT’Stop® implant (2017), 1 descendant of its own
- K241932: OSSIOfiber® Compression Staple (2024), 0 descendants of its own

## Indications for use
The SOLUSTAPLE ® is indicated for: ® Akin type osteotomy

Source page: https://510kreport.com/device/K991566
Methodology: https://510kreport.com/methodology