# K223143: SAGICO Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sagico VA USA, LLC
- Decided: Jun 26, 2023 after 265 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- 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: 13 generations back to K841189 (1984). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161710: Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion Cervical, Spinal Analytics & Geometrical Impant Co, LLC (2017) Summary page 5.

## Indications for use
The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO are to be filled with autogenous bone graft material. The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO must be used with the additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

Source page: https://510kreport.com/device/K223143
Methodology: https://510kreport.com/methodology