510(k) Report

510(k) · Cleared

Recalled · 2009

Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310)

K082032510(k) TraditionalCleared Oct 6, 200881-day reviewClass II21 CFR 888.3070Recalls 1

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

Abbott Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Oct 6, 2008 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it. It has been recalled once.

Decided
Oct 6, 2008
Review
81 days
Class
Class II
Product code
NKB
Recalls
1
Predicates
0

29 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2013: 4 descendants cleared2010: 2 descendants cleared2012: 3 descendants cleared2017: 3 descendants cleared2020: 1 descendant cleared2021: 1 descendant cleared2015: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2023: 3 descendants cleared2025: 4 descendants cleared2026: 2 descendants cleared20052010201520202025
  1. This deviceK082032 Sequoia Spinal System (Model 3306), Speedlink Transverse Connector…Abbott Spine, Inc. · 2008
  2. Descendant · cites it directly · 10 of its ownK131980 Sequoia Pedicle Screw System Including Speedlink II Transverse…Zimmer Spine, Inc. · 2013
  3. Descendant · 2 generations on · 8 of its ownK203507 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021
  4. Descendant · cites it directly · 8 of its ownK101682 S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2010
  5. Descendant · 2 generations on · 6 of its ownK162764 Jazz Frame SystemImplanet, S.A. · 2017
  6. Descendant · 3 generations on · 5 of its ownK230116 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2010: 22011: 22012: 32013: 42015: 12017: 32020: 12021: 12022: 12023: 32024: 22025: 42026: 2
2010high 4 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 29 · See all
  • K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc. · 2013 · cites it directly10descendants
  • K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021 · 2 generations on8descendants
  • K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2010 · cites it directly8descendants
  • K162764Jazz Frame SystemImplanet, S.A. · 2017 · 2 generations on6descendants
  • K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K082032Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models…Abbott Spine, Inc.2008—
+1K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc.2013—
+2K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2021—
+1K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC2010—
+2K162764Jazz Frame SystemImplanet, S.A.2017—
+3K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201120
201230
201340
201510
201730
202010
202110
202210
202330
202420
202540
202620
FIG. 1 — Lineage of K082032, 2008–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (29)

See all 29

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc.201310
K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108
K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.20104
K111301Instinct Java SystemZimmer Spine20113
K113270Instinct Java SystemZimmer Spine20112
K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130
K123552Instinct Java SystemZimmer Spine20130
K122592Instinct Java SystemZimmer Spine20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 20, 2009Not classifiedZ-0554-2010Device DesignThe tip of the instrument may fracture during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131980 (Zimmer Spine, Inc., 2013) has gone furthest, with 10 descendants of its own.

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. 2008, 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—

More from Abbott Spine, Inc.

13 FDA decisions under this applicant name. See the company

  • K090060Nexlink Oct System, Model 7000 SeriesAbbott Spine, Inc. · 2009
  • K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
  • K073202Ardis SpacerAbbott Spine, Inc. · 20081 Class I recall
  • K072672Sequoia Spinal System, Model 3300 SeriesAbbott Spine, Inc. · 20072 recalls
  • K071174Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc. · 20074 recalls

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/K082032 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082032: Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309, 3310).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082032

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026