510(k) Report

510(k) · Cleared

Cleared

Endius Spinal Fixation System

K014090510(k) TraditionalCleared Mar 11, 200290-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endius, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Mar 11, 2002 after a 90-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Mar 11, 2002
Review
90 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared2007: 1 descendant cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK014090 Endius Spinal Fixation SystemEndius, Inc. · 2002
  2. Descendant · cites it directly · 6 of its ownK021881 Endius Title Spinal Fixation SystemEndius, Inc. · 2002
  3. Descendant · 2 generations on · 5 of its ownK041808 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK060990 Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006
  5. Descendant · 4 generations on · 2 of its ownK070367 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
  6. Descendant · 3 generations on · 1 of its ownK133086 Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12006: 12007: 12011: 12013: 12015: 1
2002high 1 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 7 · See all
  • K021881Endius Title Spinal Fixation SystemEndius, Inc. · 2002 · cites it directly6descendants
  • K041808Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004 · 2 generations on5descendants
  • K060990Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006 · 3 generations on3descendants
  • K070367Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007 · 4 generations on2descendants
  • K133086Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K014090Endius Spinal Fixation SystemEndius, Inc.2002—
+1K021881Endius Title Spinal Fixation SystemEndius, Inc.2002—
+2K041808Endius Title 2 Polyaxial Spinal SystemEndius, Inc.20041
+3K060990Endius Title 2 Poly Axial Spinal SystemEndius, Inc.2006—
+4K070367Endius Title 2 Polyaxial Spinal SystemEndius, Inc.2007—
+3K133086Title 2 Polyaxial Spinal SystemZimmer Spine, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200610
200710
201110
201310
201510
FIG. 1 — Lineage of K014090, 2002–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—TriFix Spinal System
Named without a submission number
—

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021881Endius Title Spinal Fixation SystemEndius, Inc.20026

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?

  • Of its descendants, K021881 (Endius, Inc., 2002) has gone furthest, with 6 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

The Endius 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 the thoracic, lumbar, and sacral spine. The Endius 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…

Read the full statement (218 words)

The Endius 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 the thoracic, lumbar, and sacral spine.

The Endius 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Endius Spinal Fixation System is also indicated for pedicle screw fixation for severe spondylolisthesis (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 obtained. Levels of fixation are L3-S1.

In addition, the Endius Spinal Fixation System, when not used with pedicle screws, is indicated for posterior hook and sacral screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previously failed fusion surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Endius, Inc.

33 FDA decisions under this applicant name. See the company

  • K080258Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K073510Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2008
  • K073267Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2008
  • K072840Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
  • K070282Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc. · 2007

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K014090 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014090: Endius Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014090

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026