# K041105: Macropore Hydrosorb Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Jul 28, 2004 after 89 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: 2 generations back to K010911 (2001). 4 ancestors in all.
4 later devices descend from it; 3 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)
- K010911: Macropore OS Spinal System, Macropore Biosurgery, Inc. (2001) Summary page 3.
- K021039: Bowti Anterior Buttress Staple System, Depuyacromed (2002) Summary page 3.
- K000943: Cemex System Gun Application Version, Exactech, Inc. (2001) Summary page 3.
- K002063: Biotrace, Model 1730, Bryan Corp. (2000) Summary page 3.

## Most influential descendants
- K051821: Inion S-1 Biodegradable Anterior Cervical Fusion System (2005), 2 descendants of its own
- K071810: Inion Spinal Graft Containment System (2008), 1 descendant of its own
- K151360: Inion Spinal Graft Containment System (2015), 0 descendants of its own
- K063461: Anova Containment Device (2009), 0 descendants of its own

## Indications for use
The MacroPore Hydrosorb Spine 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 indications.

Source page: https://510kreport.com/device/K041105
Methodology: https://510kreport.com/methodology