# K241605: Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology

- Pathway: 510(k) (Traditional)
- Applicant: Nanovis, LLC
- Decided: Sep 5, 2024 after 93 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: 27 generations back to K841189 (1984). 444 ancestors in all.
No later device cites it as a predicate yet.
1 of 445 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191822: Nano FortiCore, FortiCore, Nanovis, LLC (2019) Summary page 6.
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 6.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 6.
- K190165: Capstone Control™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 6.
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek (2020) Summary page 6.

## Indications for use
The Adaptix™ PEEK Interbody System with Nanotechnology devices and the Capstone Control™ PEEK Spinal System with Nanotechnology devices including those with macro-, micro- and nano-roughened surface textured features are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, Adaptix™ PEEK Interbody System with Nanotechnology and the Capstone Control™ PEEK Spinal System with Nanotechnology devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Adaptix™ PEEK and the Capstone Control™ PEEK devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures and may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.

Source page: https://510kreport.com/device/K241605
Methodology: https://510kreport.com/methodology