510(k) · Cleared
ClearedEndius Title Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endius, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 29, 2002 as substantially equivalent to K014090 (Endius, Inc., 2002) after a 52-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it.
- Decided
- Jul 29, 2002
- Review
- 52 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K014090 (2002). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK014090 Endius Spinal Fixation SystemEndius, Inc. · 2002
- This deviceK021881 Endius Title Spinal Fixation SystemEndius, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK041808 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK060990 Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK070367 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK133086 Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal…Zimmer Spine, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041808Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004 · cites it directly5descendants
- K060990Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006 · 2 generations on3descendants
- K070367Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007 · 3 generations on2descendants
- K133086Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013 · 2 generations on1descendant
- K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014090 | Endius Spinal Fixation System | Endius, Inc. | 2002 | — |
| 0 (this device) | K021881 | Endius Title Spinal Fixation System | Endius, Inc. | 2002 | — |
| +1 | K041808 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2004 | 1 |
| +2 | K060990 | Endius Title 2 Poly Axial Spinal System | Endius, Inc. | 2006 | — |
| +3 | K070367 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2007 | — |
| +2 | K133086 | Title 2 Polyaxial Spinal System | Zimmer Spine, Inc. | 2013 | — |
| +3 | K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation… | Zimmer Spine, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014090 | Endius Spinal Fixation System | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041808 | Endius Title 2 Polyaxial Spinal System | 2004 | 5 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K041808 (Endius, Inc., 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (223 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021881 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021881: Endius Title Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021881
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026