# K163181: TRANSLACE™ Spinal Tethering System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 16, 2017 after 183 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: 9 generations back to K950697 (1995). 77 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110348: Universal Clamp Spinal Fixation System, Zimmer Spine (2011) Summary page 4.
- K143350: Nile Alternative Fixation, K2m, Inc. (2015) Summary page 4.

## Most influential descendants
- K172417: SILC® Fixation System (2017), 1 descendant of its own
- K230565: HILINE™ Fixation System (2023), 0 descendants of its own

## Indications for use
The TRANSLACE™ Spinal Tethering 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, congenital 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 TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K163181
Methodology: https://510kreport.com/methodology