# K202305: Zavation IBF System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Oct 13, 2020 after 60 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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). 348 ancestors in all.
9 later devices descend from it; 2 cite it directly.
1 of 358 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181246: Zavation IBF System, Zavation Medical Products, LLC (2018) Summary page 5.
- K191354: Ti3Z Cervical Interbody System, Zavation Medical Products, LLC (2019) Summary page 5.
- K171075: Calix-C Cervical Interbody Spacer, X-Spine Systems, Inc. (2017) Summary page 5.

## Most influential descendants
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K211306: Labyrinth (2021), 3 descendants of its own
- K243015: Skyway Anterior Cervical Plate System (2024), 2 descendants of its own
- K230731: Zavation ALIF System (2023), 2 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment. For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

Source page: https://510kreport.com/device/K202305
Methodology: https://510kreport.com/methodology