# K161426: NeoSpan Compression Staple Impant w/instruments

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Oct 24, 2016 after 154 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902307 (1990). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112837: Vilex EZ-Staple (Memory Bone Fixation Staple), Vilex, Inc. (2012) Summary page 4.
- K122113: Memory Metal Staples, Easyclip, Stryker Corp. (2013) Summary page 4.

## Most influential descendants
- K233089: NeoSpan® Compression Implant System (2024), 0 descendants of its own
- K190385: CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System (2019), 0 descendants of its own

## Recalls of this device
- May 11, 2026 · Class II · Z-2355-2026: Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
- Nov 14, 2018 · Class II · Z-0670-2019: The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.

## Indications for use
The In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.

Source page: https://510kreport.com/device/K161426
Methodology: https://510kreport.com/methodology