# K151064: Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Aug 12, 2015 after 114 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: 15 generations back to K003155 (2001). 132 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System, Orthofix, Inc. (2015) Summary page 6.
- K113796: Solitaire-C Cervical Spacer System, Ebi, LLC (2012) Summary page 6.
- K092336: C-Thru Spinal System, Ebi, L.P. (2009) Summary page 6.
- K103660: Lanx Cervical Intervertebral Body Fusion System, Lanx, Inc. (2011) Summary page 6.

## Most influential descendants
- K171075: Calix-C Cervical Interbody Spacer (2017), 15 descendants of its own
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K202305: Zavation IBF System (2020), 9 descendants of its own
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease (“DDD”) at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System. When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion. The Solitaire®-C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative 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. The Solitaire®-C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K151064
Methodology: https://510kreport.com/methodology