# K233089: NeoSpan® Compression Implant System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: May 24, 2024 after 241 days
- Product code: HRS (Plate, 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: 9 generations back to K954385 (1996). 85 ancestors in all.
No later device cites it as a predicate yet.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161426: NeoSpan Compression Staple Impant w/instruments, In2bones USA, LLC (2016) Summary page 4.
- K160300: MotoBand (TM) CP Implant System, Crossroads Extremity Systems, LLC (2016) Summary page 5.
- K222645: Treace Medical Concepts (TMC) Implant Fixation System, Treace Medical Concepts (2022) Summary page 5.
- K112837: Vilex EZ-Staple (Memory Bone Fixation Staple), Vilex, Inc. (2012) Summary page 5.

## Indications for use
The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

Source page: https://510kreport.com/device/K233089
Methodology: https://510kreport.com/methodology