# K133086: Title 2 Polyaxial Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Nov 27, 2013 after 58 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 K014090 (2002). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073510: Endius Title 2 Poly Axial Spinal System, Endius, Inc. (2008) Summary page 1.
- K072840: Endius Title 2 Polyaxial Spinal System, Endius, Inc. (2007) Summary page 1.
- K070367: Endius Title 2 Polyaxial Spinal System, Endius, Inc. (2007) Summary page 1.
- K060990: Endius Title 2 Poly Axial Spinal System, Endius, Inc. (2006) Summary page 1.
- K041808: Endius Title 2 Polyaxial Spinal System, Endius, Inc. (2004) Summary page 1.

## Most influential descendants
- K142752: Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System (2015), 0 descendants of its own

## Indications for use
The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogeriic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondlylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1. in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1. In addition. TiTLE 2 Polyaxial Spinal System, when not used with pedlicle screws, is indicated for sacral screw fixation from Ti to the ilium sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed, by history and radiographic studies), deformities (scoliosis, lordlosis, and kyphosis), tumor, fracture, and previous failed fusion surgery. The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

Source page: https://510kreport.com/device/K133086
Methodology: https://510kreport.com/methodology