# K131880: Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System

- Pathway: 510(k) (Abbreviated)
- Applicant: Spinefrontier, Inc.
- Decided: Jan 3, 2014 after 192 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: 11 generations back to K841189 (1984). 29 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 2.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011)

## Most influential descendants
- K212853: Cervical Stand-Alone System (2021), 18 descendants of its own
- K151198: A-CIFT SoloFuse (2015), 8 descendants of its own
- K172484: A-CIFT SoloFuse (2018), 7 descendants of its own
- K222004: INTEGRATE -C Interbody Fusion System (2023), 6 descendants of its own
- K223105: Tesera-K SC System (2022), 5 descendants of its own

## Indications for use
A-CIFr~m SoloFuseTrM is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT'm SoloFuseTM system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-TI disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthcsis at the involved level(s). Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have bad six (6) weeks 6f non-operative treatment prior to the treatment with an intervertebral spacer.

Source page: https://510kreport.com/device/K131880
Methodology: https://510kreport.com/methodology