# K131292: Deroyal Spine Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Feb 3, 2014 after 273 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: 8 generations back to K841189 (1984). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- K050449: Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2005) Summary page 2.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 2.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 2.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 2.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 2.

## Indications for use
Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine. Vertebral Body Replacement Device: The DeRoyal Spine Spacer System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine from Ti to L5. The devices are intended for use with supplemental fixation and with autograft or allograft bone. The Spine Spacer System is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K131292
Methodology: https://510kreport.com/methodology