# K162426: nva, nvp, and nvt

- Pathway: 510(k) (Special)
- Applicant: Nvision Biomedical Technologies, LLC
- Decided: Sep 29, 2016 after 30 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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 one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K142594: nva, nvp, nvt, Nvision Biomedical Technologies, LLC (2014). 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
The nva, nvp, and nvt are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

Source page: https://510kreport.com/device/K162426
Methodology: https://510kreport.com/methodology