# K113528: Clydesdale (R) Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 20, 2011 after 20 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: 11 generations back to K841189 (1984). 40 ancestors in all.
361 later devices descend from it; 9 cite it directly.
1 of 402 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) Summary page 2.
- K090353: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2009) Summary page 2.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst (2013), 281 descendants of its own
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own
- K152277: PIVOX (tm) Oblique Lateral Spinal System (2015), 190 descendants of its own
- K122989: Biomet Lateral Spacer System (2012), 171 descendants of its own
- K151310: Amendia Interbody Fusion Devices (2016), 169 descendants of its own

## Indications for use
The CLYDESDALE® 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 CLYDESDALE® 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 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 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/K113528
Methodology: https://510kreport.com/methodology