# K010911: Macropore OS Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Jul 20, 2001 after 116 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
No predicates in its family tree.
44 later devices descend from it; 8 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021039: Bowti Anterior Buttress Staple System (2002), 32 descendants of its own
- K081770: Black Widow Anterior Buttress Plate (2009), 20 descendants of its own
- 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

Source page: https://510kreport.com/device/K010911
Methodology: https://510kreport.com/methodology