# K230936: Anatomic PEEK™ Cervical Fusion System with Nanotechnology

- Pathway: 510(k) (Traditional)
- Applicant: Nanovis, LLC
- Decided: Jun 2, 2023 after 60 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: 26 generations back to K841189 (1984). 558 ancestors in all.
No later device cites it as a predicate yet.
1 of 559 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 5.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 5.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 5.
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus, Medtronic Sofamor Danek USA, Inc. (2020) Summary page 5.

## Indications for use
Anatomic PEEK™ Cervical Fusion System with Nanotechnology devices including those with macro-, micro-, and nano-roughened surface textured features are indicated for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 to T1. These patients should have had at least six weeks of non-operative treatment. The Anatomic PEEK™ device is to be used with supplemental fixation; the hyperlordotic implants (> 10°) are required to be used with an anterior cervical plate. The Anatomic PEEK™ Cervical Fusion System with Nanotechnology is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, and is to be implanted via an open anterior approach.

Source page: https://510kreport.com/device/K230936
Methodology: https://510kreport.com/methodology