# K234077: SPIRA® Anterior Lumbar Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Jul 12, 2024 after 203 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: 26 generations back to K841189 (1984). 949 ancestors in all.
No later device cites it as a predicate yet.
4 of 950 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162986: SPIRA Open Matrix ALIF, Camber Spine Technologies (2017) Summary page 6.
- K190483: SPIRA Open Matrix ALIF and LLIF, Camber Spine Technologies (2019) Summary page 6.
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Globus Medical, Inc. (2022) Summary page 6.
- K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers, Globus Medical, Inc. (2021) Summary page 6.
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 6.
- K200002: Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device, 4Web, Inc. (2020) Summary page 6.
- K180814: CoreLink® M3™ Stand-Alone Anterior Lumbar System, Corelink, LLC (2018) Summary page 6.
- K201087: CORBEL Spacers, Globus Medical, Inc. (2020) Summary page 6.

## Indications for use
The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers (SPIRA® Open Matrix ALIF, SPIRA® Open Matrix LLIF and SPIRA®-O Open Matrix Lateral Anterior Lumbar Spacers) are lumbar interbody fusion devices indicated for use at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc discase (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis). spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The SPIRA® Anterior Lumbar Spacers are intended to be used with additional FDA-cleared supplemental fixation systems. The Camber Spine Technologies SPIRA® Anterior Lumbar Spacers system must be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The Camber Spine Technologies SPIRA-A Integrated Fixation System is indicated for use at one or more levels from L1-S1 as an adjunct to fusion in skeletally mature patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy) spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The Camber Spine Technologies SPIRA-A Integrated Fixation System spacers must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. These devices are intended to be used with or without three screws and/or anchors which accompany these implants. These spacers are intended for use with additional FDA-cleared supplemental fixation. In addition, these spacers are intended for stand-alone use in patients with DDD at one or two contiguous levels only when ≤20° lordotic implants are used with three screws per implant. Otherwise, all other configurations of this system are not intended for stand-alone use and must be used with additional FDA-cleared supplemental fixation.

Source page: https://510kreport.com/device/K234077
Methodology: https://510kreport.com/methodology