# K161407: Ascential IBD PEEKc Spacer

- Pathway: 510(k) (Special)
- Applicant: Stryker Spine
- Decided: Jul 15, 2016 after 56 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: 4 generations back to K091531 (2009). 5 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142251: AVS AS PEEK Spacer, Stryker Corporation (2014) Summary page 4.

## Most influential descendants
- K181246: Zavation IBF System (2018), 22 descendants of its own
- K191354: Ti3Z Cervical Interbody System (2019), 13 descendants of its own
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K202305: Zavation IBF System (2020), 9 descendants of its own
- K200084: Zavation IBF System (2020), 8 descendants of its own

## Indications for use
The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach. The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K161407
Methodology: https://510kreport.com/methodology