# K132596: Proposed Optimus

- Pathway: 510(k) (Traditional)
- Applicant: Custom Spine, Inc.
- Decided: Apr 11, 2014 after 235 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K841189 (1984). 76 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111726: Pathway Avid, Custom Spine, Inc. (2012) Summary page 1.
- K090566: Pathway Avid, Custom Spine, Inc. (2009)
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device, Blackstone Medical, Inc. (2008) Summary page 1.
- K130445: Vault Alif System, Spinal USA (2013) Summary page 1.
- K103369: Vault Alif System, Spinal USA (2011) Summary page 1.
- K110632: Lucent or Lucent Magnum, Spinal Elements, Inc. (2012) Summary page 1.
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 1.

## Most influential descendants
- K200352: Axis Spine Technologies ALIF (2020), 2 descendants of its own
- K253559: Ventana™ A Anterior Lumbar Interbody System (2026), 0 descendants of its own
- K210590: Axis Spine Technologies ALIF (2021), 0 descendants of its own
- K202820: Australis Anterior Lumbar Cage System (2020), 0 descendants of its own
- K160291: Optimus ALIF System (2016), 0 descendants of its own

## Recalls of this device
- Nov 22, 2016 · Class II · Z-0891-2017: Complaints that the tip of the awl broke after impaction during surgery.

## Indications for use
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (U2-SI) In skeletally mature patients with degenerative disc disease (DOD). ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DOD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment. The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft, and requires no additional supplementary fixations. One device is used per intervertebral space.

Source page: https://510kreport.com/device/K132596
Methodology: https://510kreport.com/methodology