# K073351: Crystal

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jan 24, 2008 after 56 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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
No predicates in its family tree.
1,154 later devices descend from it; 27 cite it directly.
1 of 1,155 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K112036: Calix PC Spinal Implant System (2011), 775 descendants of its own
- K090064: Eminent Spine Interbody Fusion System (2009), 701 descendants of its own
- K110632: Lucent or Lucent Magnum (2012), 694 descendants of its own
- K122967: Lucent (2013), 615 descendants of its own
- K140319: Coroent TI-C System (2014), 590 descendants of its own

## Indications for use
When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft. When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

Source page: https://510kreport.com/device/K073351
Methodology: https://510kreport.com/methodology