# K021881: Endius Title Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Jul 29, 2002 after 52 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 1 generation back to K014090 (2002). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014090: Endius Spinal Fixation System, Endius, Inc. (2002)

## Most influential descendants
- K041808: Endius Title 2 Polyaxial Spinal System (2004), 5 descendants of its own
- K060990: Endius Title 2 Poly Axial Spinal System (2006), 3 descendants of its own
- K070367: Endius Title 2 Polyaxial Spinal System (2007), 2 descendants of its own
- K133086: Title 2 Polyaxial Spinal System (2013), 1 descendant of its own
- 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 Endius@TiTLETM Spinal Fixation System is indicated for degenerative disc disease (defined as discogenic 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 Endius@TiTLETM Spinal Fixation 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Endius@TiTLETM Spinal Fixation System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posteiiorkmbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S 1. In addition, the Endius@TiTLETM Spinal Fixation System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

Source page: https://510kreport.com/device/K021881
Methodology: https://510kreport.com/methodology