# K210044: Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jun 30, 2021 after 174 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: 20 generations back to K841189 (1984). 270 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153352: Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System, Spinal Elements, Inc. (2016) Summary page 13.
- K170235: Lucent®, Spinal Elements, Inc. (2017) Summary page 13.
- K150061: Lucent; Lucent Ti-Bond Systems, Spinal Elements, Inc. (2015) Summary page 13.
- K122967: Lucent, Spinal Elements, Inc. (2013) Summary page 13.
- K110632: Lucent or Lucent Magnum, Spinal Elements, Inc. (2012) Summary page 13.
- K073348: Lucent Magnum, Spinal Elements, Inc. (2007) Summary page 13.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 13.
- K151310: Amendia Interbody Fusion Devices, Amendia, Inc. (2016) Summary page 13.
- K152972: Amendia Stand-Alone Cervical System, Amendia, Inc. (2016) Summary page 13.
- K150395: Omega LIF System, Amendia, Inc. (2015) Summary page 13.

## Most influential descendants
- K230607: SPICCA Cervical Fusion Cages (2023), 0 descendants of its own

## Indications for use
Crystal® devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems). Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices. Vertu@ devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant. Lucent@ are intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). This device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device. The Zeus® Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous 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. The Zeus® Lumbar Interbody Fusion Devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The Ceres@-C Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ceres@-C Stand-Alone Cervical implant is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted with an anterior approach. The Omega XP device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous 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. Omega XP device is intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous 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/K210044
Methodology: https://510kreport.com/methodology