510(k) · Cleared
ClearedEndius Title 2 Poly Axial 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 Feb 11, 2008 as substantially equivalent to K072840 (Endius, Inc., 2007) after a 60-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.
- Decided
- Feb 11, 2008
- Review
- 60 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072840 (2007). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK072840 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
- This deviceK073510 Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2008
- 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
- Descendant · cites it directly · 0 of its ownK122592 Instinct Java SystemZimmer Spine · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K133086Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013 · cites it directly1descendant
- K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc. · 2015 · 2 generations on0descendants
- K122592Instinct Java SystemZimmer Spine · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072840 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2007 | — |
| 0 (this device) | K073510 | Endius Title 2 Poly Axial Spinal System | Endius, Inc. | 2008 | — |
| +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 | — |
| +1 | K122592 | Instinct Java System | Zimmer Spine | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K072840 | Endius Title 2 Polyaxial Spinal SystemSummary page 2…onal 510(k) Endius TITLE 2a Poly Axial Spinal System December 12, 2007 5.5 Predicate Devices Device Name(s) & 510(k) Number: Endius TiTLE 2® Poly Axial Spinal System, K072840. 5.5.1 Device Description The proposed Endius TiTLE 2®~Poly Axial Spinal System is a system that is intended to be used for pos… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 (258 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 (pseudoarthrosis).
The Endius TiTLE 2® Poly Axial Spinal 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 posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
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 Ti 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.
The Endius TiTLE 2 ® Poly Axial Spinal System can also be linked to the Minit Posterior Cervical and Upper Thoracic Fixation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073510: Endius Title 2 Poly Axial 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/K073510
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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