# K170855: T-Rex Standalone ALIF

- Pathway: 510(k) (Traditional)
- Applicant: Siats, LLC
- Decided: Sep 7, 2017 after 169 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 4 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K141942: Midline II TI, Centinel Spine, Inc. (2014). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K151785: Px HA PEEK IBF System, Innovasis, Inc. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K162351: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, SeaSpine Orthopedics Corporation (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K170511: NeoFuse HA Enhanced PLIF/TLIF, Ht Medical, LLC (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K193645: nva, nvp, and nvt (2020), 3 descendants of its own
- K212477: EARP Interbody System (2022), 1 descendant of its own
- K242457: EARP Interbody System (2024), 0 descendants of its own
- K240250: 3D Printed PEEK Interbody System (2024), 0 descendants of its own

## Indications for use
When used with the bone screws, the T-Rex Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/ or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

Source page: https://510kreport.com/device/K170855
Methodology: https://510kreport.com/methodology