# K193472: OrthoCircle Spine Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Orthocircle Spine
- Decided: Feb 13, 2020 after 59 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K040583 (2004). 272 ancestors in all.
No later device cites it as a predicate yet.
1 of 273 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171170: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws, Medacta International S.A. (2017) Summary page 5.
- K191576: Mercury® Spinal System, Overwatch® Spinal System, Spinal Elements, Inc. (2019) Summary page 5.

## Indications for use
The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and/or failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K193472
Methodology: https://510kreport.com/methodology