# K170318: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody

- Pathway: 510(k) (Traditional)
- Applicant: Ht Medical, LLC
- Decided: Jul 12, 2017 after 161 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 20 generations back to K841189 (1984). 217 ancestors in all.
49 later devices descend from it; 5 cite it directly.
1 of 267 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160125: Cascadia Interbody System, K2m (2016) Summary page 5.
- K153615: NeoFuse HA Enhanced PLIF/TLIF, Ht Medical, LLC (2016) Summary page 5.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 5.
- K120275: Synthes Acis/Vertebral Spacer CR, Synthes (Usa), LLC (2012) Summary page 5.

## Most influential descendants
- K192115: SABLE Expandable Spacer (2020), 37 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own
- K243635: aprevo® anterior lumbar interbody fusion device with interfixation (2024), 5 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
When used as a Lumbar Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least six (6) months of prior non-operative treatment prior to treatment with the device. The devices must be used with supplemental fixation and must be used with autograft/autologous bone graft to facilitate fusion for each spinal region. When used as a Cervical Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the device. The devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Source page: https://510kreport.com/device/K170318
Methodology: https://510kreport.com/methodology