# K193359: SureMAX Family of Cervical Spacers

- Pathway: 510(k) (Special)
- Applicant: Additive Implants, Inc.
- Decided: Jan 3, 2020 after 30 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K841189 (1984). 224 ancestors in all.
14 later devices descend from it; 5 cite it directly.
1 of 239 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182477: Cervical Spacer, Additive Implants, LLC (2019) Summary page 4.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 4.

## Most influential descendants
- K202666: CONSTRUX Mini PTC Spacer System (2020), 10 descendants of its own
- K203342: CONSTRUX Mini Ti Spacer System (2021), 9 descendants of its own
- K202949: CONSTRUX Mini PEEK Spacer System (2020), 6 descendants of its own
- K211704: CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System (2021), 5 descendants of its own
- K213951: FORZA XP Expandable Spacer System (2022), 4 descendants of its own

## Indications for use
The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (•10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.

Source page: https://510kreport.com/device/K193359
Methodology: https://510kreport.com/methodology