# K021039: Bowti Anterior Buttress Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Depuyacromed
- Decided: Dec 11, 2002 after 254 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K010911 (2001). 1 ancestor in all.
32 later devices descend from it; 8 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010911: Macropore OS Spinal System, Macropore Biosurgery, Inc. (2001)

## Most influential descendants
- K133911: Genesys Spine Anterior Buttress Plate System (2014), 16 descendants of its own
- K192006: SIRION Lateral Lumbar Interbody System (2020), 14 descendants of its own
- K202495: SIRION Lateral Lumbar Interbody Fusion (2021), 6 descendants of its own
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion (2023), 5 descendants of its own
- K041105: Macropore Hydrosorb Spine System (2004), 4 descendants of its own

## Indications for use
The BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Source page: https://510kreport.com/device/K021039
Methodology: https://510kreport.com/methodology