# K152512: Half Dome Posterior Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Jan 28, 2016 after 148 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: 2 generations back to K071724 (2007). 7 ancestors in all.
33 later devices descend from it; 8 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 4.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 4.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 4.

## Most influential descendants
- K163481: HALF DOME Posterior Lumbar Interbody System (2017), 31 descendants of its own
- K172947: HALF DOME Posterior Lumbar Interbody System (2018), 22 descendants of its own
- 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

## Indications for use
The Half Dome Posterior Lumbar Interbody System are 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/K152512
Methodology: https://510kreport.com/methodology