# K163481: HALF DOME Posterior Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: May 3, 2017 after 142 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: 14 generations back to K003155 (2001). 90 ancestors in all.
31 later devices descend from it; 6 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152512: Half Dome Posterior Lumbar Interbody System, Astura Medical (2016) Summary page 4.
- K160154: ALTA Anterior Cervical Interbody Spacer, Astura Medical (2016) Summary page 4.
- K131082: Interform Interbody Cage System, Next Orthosurgical (2013) Summary page 4.
- K083714: Endoskeleton TT Interbody Fusion Device (Ibd), Titan Spine, LLC (2009) Summary page 4.
- K102067: Endoskeleton to, Titan Spine, LLC (2010) Summary page 4.

## Most influential descendants
- K182877: HALF DOME Posterior Lumbar Interbody System (2019), 21 descendants of its own
- K192006: SIRION Lateral Lumbar Interbody System (2020), 14 descendants of its own
- K192492: EL CAPITAN Anterior Lumber Interbody System (2020), 10 descendants of its own
- K201287: Impulse Interbody Fusion System (2020), 8 descendants of its own
- K210090: Impulse AM Interbody Fusion System (2021), 7 descendants of its own

## Indications for use
The Half Dome Posterior Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K163481
Methodology: https://510kreport.com/methodology