# K253876: HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Dec 22, 2025 after 18 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: 28 generations back to K841189 (1984). 992 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 994 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Globus Medical, Inc. (2022) Summary page 5.
- K191243: HEDRON Cervical Spacers, Globus Medical, Inc. (2019) Summary page 5.
- K151939: COALITION Spacers, Globus Medical, Inc. (2016) Summary page 5.
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS, Globus Medical, Inc. (2017) Summary page 5.
- K231735: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System, Nu Vasive, Incorporated (2023) Summary page 5.

## Most influential descendants
- K261882: Pisces-SC Standalone Cervical Interbody System (2026), 0 descendants of its own

## Indications for use
HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. HEDRON C™ Spacers and HEDRON IC™ Spacers are intended to be used with supplemental fixation, such as an anterior cervical plate or posterior cervical fixation. When the HEDRON IC™ Spacer is used with the COALITION AGX™ Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implant. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws. HEDRON C-MIS™ Spacer is an integrated interbody fusion device indicated for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are intended to be used with or without two screws and/or anchors which accompany the implants. When used with two screws, these devices are intended for stand-alone use at one or two levels. When used with one or more anchors, these devices are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation, such as an anterior cervical plate or posterior cervical screw fixation. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws or anchors. HEDRON™ Cervical Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

Source page: https://510kreport.com/device/K253876
Methodology: https://510kreport.com/methodology