# K180909: REVEL Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 18, 2018 after 256 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
Longest line of descent: 17 generations back to K841189 (1984). 231 ancestors in all.
37 later devices descend from it; 1 cites it directly.
0 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 4.
- K153352: Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System, Spinal Elements, Inc. (2016) Summary page 4.
- K153373: CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device, Medtronic Sofamor Danek (2016) Summary page 4.
- K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K161710: Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion Cervical, Spinal Analytics & Geometrical Impant Co, LLC (2017) Summary page 4.

## Most influential descendants
- K191243: HEDRON Cervical Spacers (2019), 36 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own
- K243635: aprevo® anterior lumbar interbody fusion device with interfixation (2024), 5 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
REVEL™ Spacers (REVEL™ and REVEL™-S) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Hyperlordotic implants (>20°) must be used with supplemental fixation in addition to the two screws or anchors. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone. The REVEL™ Spacer is an interbody fusion device intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation, for one or two levels of the cervical spine. The REVEL™-S Spacer is an integrated interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implant. When used with two screws, the REVEL™-S Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine. When used with any anchors, the REVEL™-S Spacer is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

Source page: https://510kreport.com/device/K180909
Methodology: https://510kreport.com/methodology