510(k) Report

510(k) · Cleared

Cleared

Title 2 Polyaxial Spinal System

K133086510(k) TraditionalCleared Nov 27, 201358-day reviewClass II21 CFR 888.3070

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

Zimmer Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Nov 27, 2013 as substantially equivalent to K073510 (Endius, Inc., 2008) and 4 other predicates after a 58-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.

Decided
Nov 27, 2013
Review
58 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K014090 (2002). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2015: 1 descendant clearedK014090 · Endius Spinal Fixation System · Endius, Inc. · 2002K021881 · Endius Title Spinal Fixation System · Endius, Inc. · 2002K041808 · Endius Title 2 Polyaxial Spinal System · Endius, Inc. · 2004 · recalledK060990 · Endius Title 2 Poly Axial Spinal System · Endius, Inc. · 2006K070367 · Endius Title 2 Polyaxial Spinal System · Endius, Inc. · 2007200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K070367 · Endius Title 2 Polyaxial Spinal System · Endius, Inc. · 2007K060990 · Endius Title 2 Poly Axial Spinal System · Endius, Inc. · 2006K041808 · Endius Title 2 Polyaxial Spinal System · Endius, Inc. · 2004 · recalledK021881 · Endius Title Spinal Fixation System · Endius, Inc. · 2002K014090 · Endius Spinal Fixation System · Endius, Inc. · 2002−50
  1. Root · 5 generations backK014090 Endius Spinal Fixation SystemEndius, Inc. · 2002
  2. 4 generations backK021881 Endius Title Spinal Fixation SystemEndius, Inc. · 2002
  3. 3 generations backK041808 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004 · Recalled
  4. 2 generations backK060990 Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006
  5. 1 generation backK070367 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
  6. This deviceK133086 Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013
  7. Descendant · cites it directly · 0 of its ownK142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal…Zimmer Spine, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K014090Endius Spinal Fixation SystemEndius, Inc.2002—
−4K021881Endius Title Spinal Fixation SystemEndius, Inc.2002—
−3K041808Endius Title 2 Polyaxial Spinal SystemEndius, Inc.20041
−2K060990Endius Title 2 Poly Axial Spinal SystemEndius, Inc.2006—
−1K070367Endius Title 2 Polyaxial Spinal SystemEndius, Inc.2007—
0 (this device)K133086Title 2 Polyaxial Spinal SystemZimmer Spine, Inc.2013—
+1K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation…Zimmer Spine, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K133086, 2002–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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
*K073510Endius Title 2 Poly Axial Spinal System
Summary page 1
…Clearance Date .* -Predicate.Devi'e Namne -.. Number. _________ TiTLE® 2 Polyaxial Spinal System K073510 February 11, 2008 TiTLE® 2 Polyaxial Spinal System K<072840 December 7, 2007…
Endius, Inc.2008—
*K072840Endius Title 2 Polyaxial Spinal System
Summary page 1
…_________ TiTLE® 2 Polyaxial Spinal System K073510 February 11, 2008 TiTLE® 2 Polyaxial Spinal System K<072840 December 7, 2007 TiTLE® 2 Polyaxial Spinal System K070367 April 12, 2007 T…
Endius, Inc.2007—
*K070367Endius Title 2 Polyaxial Spinal System
Summary page 1
…February 11, 2008 TiTLE® 2 Polyaxial Spinal System K<072840 December 7, 2007 TiTLE® 2 Polyaxial Spinal System K070367 April 12, 2007 TiTLE® 2 Polyaxial Spinal System K060990 April26, 2006 T…
Endius, Inc.2007—
*K060990Endius Title 2 Poly Axial Spinal System
Summary page 1
…December 7, 2007 TiTLE® 2 Polyaxial Spinal System K070367 April 12, 2007 TiTLE® 2 Polyaxial Spinal System K060990 April26, 2006 TiTLE® 2 Polyaxial Spinal System K041808 October 1,2004…
Endius, Inc.2006—
*K041808Endius Title 2 Polyaxial Spinal System
Summary page 1
…April 12, 2007 TiTLE® 2 Polyaxial Spinal System K060990 April26, 2006 TiTLE® 2 Polyaxial Spinal System K041808 October 1,2004 80 of 613…
Endius, Inc.20041

Also cleared against K073510: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150

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 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K142752 (Zimmer Spine, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K073510.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogeriic 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 TiTLE 2 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…

Read the full statement (243 words)

The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogeriic 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 TiTLE 2 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 spondlylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The TiTLE 2 Polyaxial Spinal 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 attained. Levels of fixation are from L3-S1.

In addition. TiTLE 2 Polyaxial Spinal System, when not used with pedlicle screws, is indicated for sacral screw fixation from Ti 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, lordlosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.

The TiTLE 2 Polyaxial 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.

Also cleared against K073510

1 other device cites the same predicate.

  • K122592Instinct Java SystemZimmer Spine · 20131 recall

More from Zimmer Spine, Inc.

52 FDA decisions under this applicant name. See the company

  • K153631Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2016
  • K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 20153 recalls
  • K151031Virage OCT Spinal Fixation SystemZimmer Spine, Inc. · 2015
  • K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical…Zimmer Spine, Inc. · 2015
  • K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix…Zimmer Spine, Inc. · 2015

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K133086 · printed Nov 5, 2026

Cite this page

510(k) Report. “K133086: Title 2 Polyaxial Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133086

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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