510(k) · Cleared
ClearedVital™ Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimvie Spine (Zimmer Biomet Spine, Inc.) · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 11, 2023 as substantially equivalent to K203507 (Zimmer Biomet Spine, Inc., 2021) after a 267-day review. Its family tree reaches back 4 generations to 2002. 5 later devices descend from it.
- Decided
- Oct 11, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021564 (2002). 8 ancestors in all, the oldest K915478 (1992). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK021564 Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
- 3 generations backK023644 Modification to Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
- 2 generations backK131980 Sequoia Pedicle Screw System Including Speedlink II Transverse…Zimmer Spine, Inc. · 2013
- 1 generation backK203507 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021
- This deviceK230116 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023
- Descendant · cites it directly · 4 of its ownK240539 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024
- Descendant · 2 generations on · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · 3 generations on · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · 2 generations on · 0 of its ownK262828 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · 2 generations on · 0 of its ownK253093 Vital™ Spinal Fixation SystemHighridge Medical, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024 · cites it directly4descendants
- K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · 2 generations on2descendants
- K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 3 generations on1descendant
- K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 2 generations on0descendants
- K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021564 | Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | 1 |
| −3 | K023644 | Modification to Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | 1 |
| −2 | 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 | — |
| 0 (this device) | K230116 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2023 | — |
| +1 | K240539 | Vital™ Spinal Fixation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | 2024 | — |
| +2 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +3 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +2 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +2 | K253093 | Vital™ Spinal Fixation System | Highridge Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K203507 | Vitality® Spinal Fixation SystemSummary page 5…ate Devices Primary Predicate: Vital™ Spinal Fixation System (K203507) Device Description The Vital™ Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the s… | 2021 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240539 | Vital™ Spinal Fixation System | 2024 | 4 |
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 21 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K240539 (Zimvie Spine (Zimmer Biomet Spine, Inc.), 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K203507.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral fixation (T8‑L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic…
Read the full statement (339 words)
The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral fixation (T8‑L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital/Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vital/Vitality Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital/Vitality System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital/Vitality System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The use of the Vital/Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System* hooks, APEX Spinal System™* hooks, or fixation of the Universal Clamp® Spinal Fixation System* to the rods of the Vital/Vitality Spinal Fixation System. The Vital/Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.
In order to achieve additional levels of fixation in skeletally mature patients, the Vital/Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230116 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230116: Vital™ Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230116
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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