# K211111: SureMAX-SA Cervical Standalone System

- Pathway: 510(k) (Traditional)
- Applicant: Additive Implants, Inc.
- Decided: Jul 16, 2021 after 93 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 23 generations back to K841189 (1984). 323 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 332 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151939: COALITION Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K193000: Hexanium® ACIF, Spinevision, S.A.S. (2020) Summary page 4.

## Most influential descendants
- K223105: Tesera-K SC System (2022), 5 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K250486: Skyway Anterior Cervical Plate System (2025), 1 descendant of its own
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own

## Indications for use
The SureMAX-SA™ Cervical Standalone System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients as an adjunct to fusion for the treatment of degenerative disc disease (DDD). DDD is defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with the device. The SureMAX-SA™ Cervical Standalone System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. When used with the fixed or variable screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one or two levels from C2-T1 and requires no additional fixation. When used with one or more helical screws, the SureMAX-SA™ Cervical Standalone System is intended to be used at one level and with supplemental fixation.

Source page: https://510kreport.com/device/K211111
Methodology: https://510kreport.com/methodology