# K052054: TSRH Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 16, 2005 after 18 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040583 (2004). 13 ancestors in all.
786 later devices descend from it; 8 cite it directly.
1 of 800 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050282: Modification to TSRH Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 2.
- K991031: Colorado II Spinal System, Sofamor Danek USA,Inc. (2000). Our reading of the summary gave K991091, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “COLORADO I® Spinal System”.
- K032560: Arrowhead Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own
- K072317: Modification to:TSRH Spinal System (2007), 625 descendants of its own
- K081080: TSRH Spinal System (2008), 614 descendants of its own
- K091797: TSRH Spinal System (2010), 606 descendants of its own
- K102555: CD Horizon Spinal System (2010), 598 descendants of its own

## Indications for use
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the TSRII® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion. For anterior use only the TSRHt® Spinal System has the additional indications of. (1) spinal stenosis and/or, (2) spondylolysis.

Source page: https://510kreport.com/device/K052054
Methodology: https://510kreport.com/methodology