# K182877: HALF DOME Posterior Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical, LLC
- Decided: May 3, 2019 after 200 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: 15 generations back to K003155 (2001). 121 ancestors in all.
21 later devices descend from it; 7 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 4.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K123231: Caliber Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K152512: Half Dome Posterior Lumbar Interbody System, Astura Medical (2016) Summary page 4.
- K163481: HALF DOME Posterior Lumbar Interbody System, Astura Medical (2017) Summary page 4.
- K172947: HALF DOME Posterior Lumbar Interbody System, Astura Medical (2018) Summary page 4.

## Most influential descendants
- 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
- K202495: SIRION Lateral Lumbar Interbody Fusion (2021), 6 descendants of its own
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion (2023), 5 descendants of its own
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (2023), 3 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 SYSTEM 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/K182877
Methodology: https://510kreport.com/methodology