# K171107: CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Sep 26, 2017 after 165 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: 16 generations back to K003155 (2001). 163 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 5.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 5.
- K133205: Capstone PTC Spinal System, Clydesdale PTC Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K122037: Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst, Medtronic Sofamor Danek, Inc. (2013) Summary page 5.

## Most influential descendants
- K190165: Capstone Control™ Spinal System (2019), 6 descendants of its own
- K192502: Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus (2020), 4 descendants of its own
- K241164: IB3D™ PL Spinal System (2024), 1 descendant of its own
- K253577: IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (2025), 0 descendants of its own
- K251431: FIX-C PEEK ACIF SA System (2025), 0 descendants of its own

## Indications for use
The CAPSTONE CONTROL™ Spinal System, including the CAPSTONE CONTROL PTC™ Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. When used for these indications, the CAPSTONE CONTROL™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE CONTROL™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

Source page: https://510kreport.com/device/K171107
Methodology: https://510kreport.com/methodology