510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Vitality® Spinal Fixation System

K183550510(k) TraditionalCleared Apr 8, 2019109-day reviewClass II21 CFR 888.3070Recalls 23

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

Zimmer Biomet Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 8, 2019 after a 109-day review. The FDA summary names no predicate by number. 9 later devices descend from it. It has been recalled 23 times.

Decided
Apr 8, 2019
Review
109 days
Class
Class II
Product code
NKB
Recalls
23
Predicates
0

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

Descendants, by year cleared 2021: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2025: 2 descendants cleared2026: 2 descendants cleared201620182020202220242026
  1. This deviceK183550 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2019
  2. Descendant · cites it directly · 8 of its ownK203507 Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021
  3. Descendant · 2 generations on · 5 of its ownK230116 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2023
  4. Descendant · 3 generations on · 4 of its ownK240539 Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.) · 2024
  5. Descendant · 4 generations on · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
  6. 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 9 descendants. See all descendants

Descendants cleared per year

2021: 12022: 12023: 12024: 22025: 22026: 2
2021high 2 (2024) · low 1 (2021)2026

Most influential descendants

Showing 5 of 9 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K183550Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2019—
+1K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2021—
+2K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)2023—
+3K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)2024—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2025—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202310
202420
202520
202620
FIG. 1 — Lineage of K183550, 2019–2026Source: 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), 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?

The FDA summary names no predicate by number.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.20218

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

Recalls of this device

DateClassRecallRoot causeReason
May 5, 2020Class IIZ-2212-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2231-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2225-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2229-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2219-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2221-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2218-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2230-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2226-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2211-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2224-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2217-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2216-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2214-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2232-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2223-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2222-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2233-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2220-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2227-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2234-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2210-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
May 5, 2020Class IIZ-2228-2020Under Investigation by firmThere are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.

The 5 latest of 23 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K203507 (Zimmer Biomet Spine, Inc., 2021) has gone furthest, with 8 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. 2019, 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 Zimmer Biomet Spine, Inc.

15 FDA decisions under this applicant name. See the company

  • K212023Virage Navigation SystemZimmer Biomet Spine, Inc. · 2021
  • K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc. · 2021
  • K210275Polaris Spinal SystemZimmer Biomet Spine, Inc. · 2021
  • K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. · 2021
  • K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System…Zimmer Biomet Spine, Inc. · 2020

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/K183550 · printed Nov 5, 2026

Cite this page

510(k) Report. “K183550: Vitality® 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/K183550

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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