# K193645: nva, nvp, and nvt

- Pathway: 510(k) (Special)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Jan 13, 2020 after 14 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
Longest line of descent: 16 generations back to K841189 (1984). 90 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162426: nva, nvp, and nvt, Nvision Biomedical Technologies, LLC (2016) Summary page 5.
- K142594: nva, nvp, nvt, Nvision Biomedical Technologies, LLC (2014) Summary page 5.
- K170855: T-Rex Standalone ALIF, Siats, LLC (2017) Summary page 5.
- K180502: S128 Anterior Lumbar Interbody Fusion (ALIF) System, Renovis Surgical Technologies, Inc. (2018) Summary page 5.

## Most influential descendants
- 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. Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation or anterior buttress plate with posterior supplemental fixation.

Source page: https://510kreport.com/device/K193645
Methodology: https://510kreport.com/methodology