# K021170: TSRH Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jul 9, 2002 after 88 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
127 later devices descend from it; 5 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CDB Spinal System 4.0mm screws: named in the summary without a submission number
- (no number) TSRH Spinal System: named in the summary without a submission number

## Most influential descendants
- K100737: Modification to: Trio+Spinal Fixation System (2010), 86 descendants of its own
- K103292: Trio Trauma Spinal System (2011), 85 descendants of its own
- K133188: Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal (2013), 84 descendants of its own
- K142381: Xia 3 Spinal System (2014), 83 descendants of its own
- K131250: Tiger Spine System (2013), 40 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@ Spina1 System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (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) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) 'scoliosis, ( 6 ) kyphosis, (7) spinal tumor, and (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: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebraljoint; (b) who are receiving fusions using autogenous bone graft only; (c) 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 defmed by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. When used as an anterolateraVanterior 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (Le., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (Tl-LS) and into anterior vertebral bodies of the cervical spine.

Source page: https://510kreport.com/device/K021170
Methodology: https://510kreport.com/methodology