# K081770: Black Widow Anterior Buttress Plate

- Pathway: 510(k) (Traditional)
- Applicant: Omni Surgical, L.P.
- Decided: Apr 2, 2009 after 283 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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: 1 generation back to K010911 (2001). 1 ancestor in all.
20 later devices descend from it; 3 cite it directly.
0 of 22 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) Summary page 1.

## 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
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (2023), 3 descendants of its own

## Recalls of this device
- Nov 22, 2016 · Class II · Z-0886-2017: There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
- Nov 22, 2016 · Class II · Z-0887-2017: There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.

## Indications for use
The Black Widow Anterior Buttress Plate 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. The device is not intended for load bearing applications.

Source page: https://510kreport.com/device/K081770
Methodology: https://510kreport.com/methodology