# K052144: TSRH Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 31, 2005 after 23 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981676 (1999). 4 ancestors in all.
665 later devices descend from it; 3 cite it directly.
1 of 670 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042210: MSD Silo Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K041030: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K090390: CD Horizon Spinal System (2009), 663 descendants of its own
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own
- K102555: CD Horizon Spinal System (2010), 598 descendants of its own
- K112473: CD Horizon Spinal System (2011), 597 descendants of its own
- K112555: CD Horizon (R) Spinal System (2011), 597 descendants of its own

## Recalls of this device
- Aug 24, 2007 · Not classified · Z-0074-2008: Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

## 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 TSRH Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-SI) 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 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 TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.

Source page: https://510kreport.com/device/K052144
Methodology: https://510kreport.com/methodology