# K113796: Solitaire-C Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, LLC
- Decided: Apr 26, 2012 after 125 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K841189 (1984). 83 ancestors in all.
142 later devices descend from it; 4 cite it directly.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081395: Solitaire Peek-Optima Anterior Spinal System, Biomet Spine (2008) Summary page 1.
- K093629: Solitaire and Solitaire Peek Anterior Spinal System, Biomet Spine (2010) Summary page 1.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 1.
- K072981: Synthes Zero-P, Synthes Spine Co.Lp (2008) Summary page 1.
- K093762: Synthes Zero-P, Synthes Spine (2010) Summary page 1.
- K092336: C-Thru Spinal System, Ebi, L.P. (2009) Summary page 1.

## Most influential descendants
- K132029: Vault-C Intervertebral Body Fusion Device (2013), 108 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

## Recalls of this device
- Nov 11, 2014 · Class II · Z-0874-2015: A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their

## Indications for use
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 TI. 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 Solitaireo-C Cervical Spacer System is to be used with autograft 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/K113796
Methodology: https://510kreport.com/methodology