# K100175: Clydesdale Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Jun 2, 2010 after 132 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
Longest line of descent: 10 generations back to K841189 (1984). 29 ancestors in all.
1,008 later devices descend from it; 16 cite it directly.
1 of 1,038 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083026: Clydesdale Spinal System, Medtronic Sofamor Danek (2008) Summary page 2.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K110543: Crescent (R) Spinal System Titanium (2011), 808 descendants of its own
- K121760: Capstone Spinal System (2012), 723 descendants of its own
- K123027: Capstone (R) Spinal System (2013), 709 descendants of its own
- K121683: Acculif TL Cage (2012), 682 descendants of its own
- K123752: Acculif TL and PL Cage (2013), 676 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 (DOD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade I 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 he 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/K100175
Methodology: https://510kreport.com/methodology