# K163364: MOJAVE Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: K2m
- Decided: Mar 15, 2017 after 105 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: 20 generations back to K841189 (1984). 202 ancestors in all.
25 later devices descend from it; 7 cite it directly.
1 of 228 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 4.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 4.
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.

## Most influential descendants
- K171097: MOJAVE Expandable Interbody System (2017), 17 descendants of its own
- K193203: MOJAVE Expandable Interbody System (2020), 15 descendants of its own
- K211873: PSX Interbody System (2021), 11 descendants of its own
- K222455: Calibrate LTX Interbody System (2022), 8 descendants of its own
- K231438: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (2023), 7 descendants of its own

## Indications for use
The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K163364
Methodology: https://510kreport.com/methodology