# K083026: Clydesdale Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 29, 2008 after 80 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,042 later devices descend from it; 8 cite it directly.
1 of 1,043 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own
- K110543: Crescent (R) Spinal System Titanium (2011), 808 descendants of its own
- K090353: Perimeter Interbody Fusion Device (2009), 796 descendants of its own
- K120368: Capstone Control Spinal System (2012), 761 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own

## Indications for use
The CLYDESDALETM Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALETM Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

Source page: https://510kreport.com/device/K083026
Methodology: https://510kreport.com/methodology