# K161265: NuVasive® VersaTie System

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Jul 15, 2016 after 71 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K925812 (1993). 32 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142053: Universal Clamp Spinal Fixation System, Zimmer Spine, Inc. (2014) Summary page 4.
- K151740: JAZZ System, Implanet, S.A. (2015) Summary page 4.

## Most influential descendants
- K173117: NuVasive® VersaTie™ System (2017), 2 descendants of its own
- K191217: Jazz PF (2019), 0 descendants of its own
- K190418: NuVasive® VersaTie® System (2019), 0 descendants of its own

## Indications for use
The NuVasive® VersaTie System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt- chromium alloy whenever “wiring” may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K161265
Methodology: https://510kreport.com/methodology