# K103049: TSRH Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 23, 2010 after 69 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: 5 generations back to K040583 (2004). 21 ancestors in all.
244 later devices descend from it; 2 cite it directly.
0 of 266 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010720: TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2001) Summary page 3.
- K022778: Modification to TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2002) Summary page 4.
- K093058: TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2009) Summary page 3.

## Most influential descendants
- K111942: TSRH Spinal Systems (2011), 242 descendants of its own
- K123138: Pass LP Spinal System (2013), 132 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own
- K142798: PASS LP Spinal System (2015), 84 descendants of its own
- K152968: Arsenal Spinal Fixation System (2015), 83 descendants of its own

## Indications for use
When used as a pedicle screw fixation system of the non-cervical posterior spine, In skeletally mature patients, the TSRH@ Spinal System is Indicated for one or more of the followng (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 ThRH® Spinal System is Indicated for skeletally mature patients: (±) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L.5-Si) vertebral 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 (13 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 b9 patient history and radiographic studies), (2),spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scollosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8)unsuccessful previous attempts at spinal fusion. When used as a unilateral supplemental fixation device In the antero-lateral thoracic/lumbar region, the TSRH8 1-Plate and VANTAGEW screws are Intended for the following Indications: spondylolisthesis; trauma (ILe., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosls; and/or failed previous fusion. For anterior use only the TSRHO Spinal System has the additional indication of: spondylolysis.

Source page: https://510kreport.com/device/K103049
Methodology: https://510kreport.com/methodology