510(k) · Cleared
ClearedSequoia Pedicle Screw System Including Speedlink II Transverse Connector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 4, 2013 as substantially equivalent to K082032 (Abbott Spine, Inc., 2008) and 3 other predicates after a 68-day review. Its family tree reaches back 2 generations to 2002. 10 later devices descend from it.
- Decided
- Sep 4, 2013
- Review
- 68 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K021564 (2002). 5 ancestors in all, the oldest K915478 (1992). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK021564 Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
- 1 generation backK023644 Modification to Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
- This deviceK131980 Sequoia Pedicle Screw System Including Speedlink II Transverse…Zimmer Spine, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK203507 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK230116 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023
- Descendant · 3 generations on · 4 of its ownK240539 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024
- Descendant · 4 generations on · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · 5 generations on · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021 · cites it directly8descendants
- K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023 · 2 generations on5descendants
- K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024 · 3 generations on4descendants
- K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · 4 generations on2descendants
- K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021564 | Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | 1 |
| −1 | K023644 | Modification to Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | 1 |
| 0 (this device) | K131980 | Sequoia Pedicle Screw System Including Speedlink II Transverse Connector System | Zimmer Spine, Inc. | 2013 | — |
| +1 | K203507 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | 2021 | — |
| +2 | K230116 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023 | — |
| +3 | K240539 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024 | — |
| +4 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +5 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K082032 | Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…Summary page 1…e Date Predicate Device Name Number _________ Sequoia®&Pedicle Screw System including K082032 October 6, 2008 Speedlink Transverse Connector System __________ _________ Modificatio… | 2008 |
| * | K023644 | Modification to Incompass Spinal Fixation SystemSummary page 1…, 2008 Speedlink Transverse Connector System __________ _________ Modification To Incompass Spinal Fixation System K023644 November 25, 2002 Synergy D2 Spinal Implants K9154578 March 23, 1999 Titani… | 2002 |
| * | K915478 | Sensicare Synthetic Medical Gloves | 1992 |
| * | K946348 | Titanium TSRH (R) Spinal System (Screws)Summary page 1…2 Synergy D2 Spinal Implants K9154578 March 23, 1999 Titanium TSRH(R) Spinal System (Screws) K946348 August 7, 1995… | 1995 |
What descends from it? (10)
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K203507 (Zimmer Biomet Spine, Inc., 2021) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K082032.
How does its category compare?
All NKB devicesNKB 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
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?
When intended for pedicle screw fixation from Ti-S1, the Sequoia® Pedicle Screw System is 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and…
Read the full statement (206 words)
When intended for pedicle screw fixation from Ti-S1, the Sequoia® Pedicle Screw System is 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (Ti-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131980: Sequoia Pedicle Screw System Including Speedlink II Transverse Connector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131980
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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