# K133218: Crystal ®; Mosaic ®; Vertu ®

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Dec 10, 2014 after 418 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: 3 generations back to K072991 (2008). 8 ancestors in all.
130 later devices descend from it; 6 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112036: Calix PC Spinal Implant System, X-Spine Systems, Inc. (2011) Summary page 5.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 5.
- K071833: Mosaic Devices, Spinal Elements, Inc. (2007) Summary page 5.
- K122771: Spinal Elements Cervical Intervertebral Body Fusion System, Spinal Elements, Inc. (2013) Summary page 5.

## Most influential descendants
- K181837: Spinal Elements Ti-Bond coated devices (2018), 98 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own

## Indications for use
Crystal®: The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck 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. The Crystal® device is intended to be used with supplemental spinal 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 non-operative treatment prior to being treated with these devices. Mosaic®: The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck 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. 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, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant. Vertu®: The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck 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. 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.

Source page: https://510kreport.com/device/K133218
Methodology: https://510kreport.com/methodology