# K133291: ST360 Degrees Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Dec 17, 2013 after 53 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: 5 generations back to K980288 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022374: Cadence Spinal Fixation System, Sulzer Spine-Tech (2002) Summary page 1.
- K041925: ST360 Spinal Fixation System, Zimmer Spine, Inc. (2004) Summary page 1.
- K072183: ST360 Spinal Fixation System, Model 07.0029-7500.5600, Zimmer Spine, Inc. (2007) Summary page 1.

## Most influential descendants
- K142752: Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System (2015), 0 descendants of its own

## Indications for use
The ST360 Spinal Fixation System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients. When used as a sacral screw system, the ST360 Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360 Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.

Source page: https://510kreport.com/device/K133291
Methodology: https://510kreport.com/methodology