# K191788: CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA, Inc. - Decided: Mar 23, 2020 after 264 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: 17 generations back to K003155 (2001). 172 ancestors in all. No later device cites it as a predicate yet. 0 of 173 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 6. - K082342: Modification to Capstone Spinal System, Medtronic Sofamor Danek (2008) Summary page 6. - K082732: Modification to: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 6. - K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 6. - K110543: Crescent (R) Spinal System Titanium, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 6. - K121760: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 6. - K133205: Capstone PTC Spinal System, Clydesdale PTC Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 6. - K133650: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 6. - K172199: ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, Medtronic Sofamor Danek (2017) Summary page 6. - K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6. ## Indications for use The CAPSTONE™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine. The CLYDESDALE PTC™ 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 PTC™ 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. The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 nonoperative treatment. These implants are to be used autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine. The CRESCENT Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients 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 are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients 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. Additionally, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCEL™ Anterior/Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. Source page: https://510kreport.com/device/K191788 Methodology: https://510kreport.com/methodology