510(k) · Cleared
ClearedEndius Title 2 Polyaxial Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endius, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 12, 2007 as substantially equivalent to K060990 (Endius, Inc., 2006) after a 63-day review. Its family tree reaches back 4 generations to 2002. 2 later devices descend from it.
- Decided
- Apr 12, 2007
- Review
- 63 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014090 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK014090 Endius Spinal Fixation SystemEndius, Inc. · 2002
- 3 generations backK021881 Endius Title Spinal Fixation SystemEndius, Inc. · 2002
- 2 generations backK041808 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004 · Recalled
- 1 generation backK060990 Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006
- This deviceK070367 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK133086 Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal…Zimmer Spine, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014090 | Endius Spinal Fixation System | Endius, Inc. | 2002 | — |
| −3 | K021881 | Endius Title Spinal Fixation System | Endius, Inc. | 2002 | — |
| −2 | K041808 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2004 | 1 |
| −1 | K060990 | Endius Title 2 Poly Axial Spinal System | Endius, Inc. | 2006 | — |
| 0 (this device) | K070367 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2007 | — |
| +1 | K133086 | Title 2 Polyaxial Spinal System | Zimmer Spine, Inc. | 2013 | — |
| +2 | 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 |
|---|---|---|
| 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K060990 | Endius Title 2 Poly Axial Spinal SystemSummary page 2…fication to Endius TiTLE 2 Poly Axial Spinal System February 07, 2007 5.5 Predicate Devices Device Name(s) & 510(k) Number: Endius TiTLE 28 Poly Axial Spinal System, K060990. 5.5.1 Device Description The proposed Endius TiTLE 2 ® Poly Axial Spinal System is a system that is intended to be used for po… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133086 | Title 2 Polyaxial Spinal System | 2013 | 1 |
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K133086 (Zimmer Spine, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K060990.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Endius TiTLE 2® Poly Axial Spinal 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 TiTLE 2® Poly Axial Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to…
Read the full statement (236 words)
The Endius TiTLE 2® Poly Axial Spinal 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 TiTLE 2® Poly Axial 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoartlirosis).
The Endius TiTLE 2® Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-Sl, 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-S 1.
In addition, the Endius TiTLE 2® Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from Tl 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, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070367: Endius Title 2 Polyaxial Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070367
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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