# K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF

- Pathway: 510(k) (Traditional)
- Applicant: Spinevision S.A.
- Decided: May 4, 2016 after 125 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: 11 generations back to K841189 (1984). 29 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 4.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) 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.

## Most influential descendants
- K192026: Peridot Intervertebral body fusion System (2019), 6 descendants of its own
- K202872: Prase PEEK Anterior Cervical Interbody Spacer (2021), 5 descendants of its own
- K213980: Peridot Spinal Interbody System (2022), 4 descendants of its own
- K230708: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (2023), 3 descendants of its own
- K232822: Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (2023), 2 descendants of its own

## Indications for use
The SpaceVision® PLIF (Posterior Lumbar Interbody Fusion), the SpaceVision® TLIF (Transforaminal Lumbar Interbody Fusion) and SpaceVision® OLIF (Oblique Lumbar Interbody Fusion) systems are intervertebral body fusion devices indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems. These devices are to be filled with autogenous bone graft material. These devices can be implanted via posterior or transforaminal approaches. SpaceVision® PLIF, SpaceVision® TLIF or SpaceVision® OLIF systems must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K153783
Methodology: https://510kreport.com/methodology