# K041925: ST360 Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Zimmer Spine, Inc.
- Decided: Sep 24, 2004 after 67 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980288 (1998). 3 ancestors in all.
83 later devices descend from it; 4 cite it directly.
0 of 87 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.

## Most influential descendants
- K070245: Capsure Pedicle Screw System (2007), 42 descendants of its own
- K081228: Capsure PS (R) Spine System (2008), 39 descendants of its own
- K083353: Capsure (R) PS System (2008), 36 descendants of its own
- K100605: Mis System (2010), 33 descendants of its own
- K072183: ST360 Spinal Fixation System, Model 07.0029-7500.5600 (2007), 27 descendants of its own

## Recalls of this device
- Oct 5, 2006 · Not classified · Z-0190-2007: Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.

## Indications for use
The ST360° Spinal System is intended for posterior, noncervical 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 hook and 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. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are Tl to the sacrum.

Source page: https://510kreport.com/device/K041925
Methodology: https://510kreport.com/methodology