# K132029: Vault-C Intervertebral Body Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Nov 25, 2013 after 147 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: 14 generations back to K841189 (1984). 100 ancestors in all.
108 later devices descend from it; 6 cite it directly.
0 of 209 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120819: Stalif C, Centinel Spine, Inc. (2012). Our reading of the summary gave K121819, FDA’s number for Surgiclear Antimicrobial Clear Silicone Adhesive Dressing… (Covalontechnologies, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Centinel Spine Stalif C System”. Summary page 2.
- K113796: Solitaire-C Cervical Spacer System, Ebi, LLC (2012) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 1.
- K121151: Pro-Link Cervical Spacer System, Life Spine, Inc. (2012) Summary page 1.
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own

## Indications for use
The Vault-C Standalone Cervical Interbody Fusion System is astandalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (ODD) of' the cervical spine (C3-T I) at one disc level. ODD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with aucogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-I disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device

Source page: https://510kreport.com/device/K132029
Methodology: https://510kreport.com/methodology