510(k) · Cleared
Recalled · Class II · 2013Endius Title 2 Polyaxial Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endius, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Oct 1, 2004 as substantially equivalent to K021881 (Endius, Inc., 2002) after an 87-day review. Its family tree reaches back 2 generations to 2002. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 1, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K014090 (2002). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK014090 Endius Spinal Fixation SystemEndius, Inc. · 2002
- 1 generation backK021881 Endius Title Spinal Fixation SystemEndius, Inc. · 2002
- This deviceK041808 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK060990 Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK070367 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
- Descendant · cites it directly · 0 of its ownK111995 Xingtm Spine SystemImplanova Co., Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K060990Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006 · cites it directly3descendants
- K070367Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007 · 2 generations on2descendants
- 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
- K111995Xingtm Spine SystemImplanova Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014090 | Endius Spinal Fixation System | Endius, Inc. | 2002 | — |
| −1 | K021881 | Endius Title Spinal Fixation System | Endius, Inc. | 2002 | — |
| 0 (this device) | K041808 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2004 | — |
| +1 | K060990 | Endius Title 2 Poly Axial Spinal System | Endius, Inc. | 2006 | — |
| +2 | 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 | — |
| +1 | K111995 | Xingtm Spine System | Implanova Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KWP? 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 |
|---|---|---|---|
| * | K021881 | Endius Title Spinal Fixation SystemSummary page 2…Endius® TiTLE2Th Polyaxial Spinal System July 2, 2004 7.5 Predicate Device Endius TiTLE Spinal Fixation System: K021881 7.6 The Endius® TITLE 2TM Polyaxial Spinal System is a system that is intended to Device be used for pos… | 2002 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2013 | Class II | Z-0574-2015 | Nonconforming Material/Component | Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K060990 (Endius, Inc., 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Endius® TITLE 2TM Polyaxial 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 2TM 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…
Read the full statement (231 words)
The Endius® TITLE 2TM Polyaxial 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 2TM 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Endius® TITLE 2TM Polyaxial 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 Polyaxial Spinal 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/K041808 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041808: 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/K041808
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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