# K041592: Coral Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical
- Decided: Sep 16, 2004 after 94 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: 1 generation back to K955348 (1996). 2 ancestors in all.
261 later devices descend from it; 8 cite it directly.
0 of 264 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991031: Colorado II Spinal System, Sofamor Danek USA,Inc. (2000) Summary page 1.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 1.

## Most influential descendants
- K070962: Coral Pedicle Screw System (2007), 118 descendants of its own
- K110280: Revlok Fenestrated Screw System (2011), 95 descendants of its own
- K102204: Choice Spine Starfire Pedicle Screw System (2010), 88 descendants of its own
- K072407: Bodyform Thoracic Fixation System (2007), 87 descendants of its own
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems (2014), 82 descendants of its own

## Recalls of this device
- Oct 4, 2005 · Not classified · Z-0183-06: The torque value of the device may increase over time. The increase could exceed the tolerance specification.

## Indications for use
The CoralTM Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K041592
Methodology: https://510kreport.com/methodology