510(k) Report

510(k) · Cleared

Cleared

Zavation Spinal System

K112484510(k) TraditionalCleared Nov 22, 201185-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

Zavation, LLC · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Nov 22, 2011 as substantially equivalent to K955348 (Depuy, Inc., 1996) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.

Decided
Nov 22, 2011
Review
85 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K955348 (1996). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2023: 2 descendants cleared2020: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant clearedK955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants K955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 19960
  1. Root · 1 generation backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
  2. This deviceK112484 Zavation Spinal SystemZavation, LLC · 2011
  3. Descendant · cites it directly · 1 of its ownK202624 Z-Span Plate SystemZavation Medical Products, LLC · 2020
  4. Descendant · cites it directly · 1 of its ownK153404 Zavation Spinal SystemZavation, LLC · 2016
  5. Descendant · cites it directly · 0 of its ownK231811 Zavation Connector SystemZavation Medical Products, LLC · 2023
  6. Descendant · 2 generations on · 0 of its ownK230721 ATEC Lateral Plate SystemAlphatec Spine, Inc. · 2023
  7. Descendant · 2 generations on · 0 of its ownK190361 Zavation Spinal SystemZavation Medical Products, LLC · 2019

Most influential descendants

Showing 5 of 5 · See all
  • K202624Z-Span Plate SystemZavation Medical Products, LLC · 2020 · cites it directly1descendant
  • K153404Zavation Spinal SystemZavation, LLC · 2016 · cites it directly1descendant
  • K231811Zavation Connector SystemZavation Medical Products, LLC · 2023 · cites it directly0descendants
  • K230721ATEC Lateral Plate SystemAlphatec Spine, Inc. · 2023 · 2 generations on0descendants
  • K190361Zavation Spinal SystemZavation Medical Products, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K955348Titanium Moss Miami Spinal SystemDepuy, Inc.1996—
0 (this device)K112484Zavation Spinal SystemZavation, LLC2011—
+1K202624Z-Span Plate SystemZavation Medical Products, LLC2020—
+1K153404Zavation Spinal SystemZavation, LLC2016—
+1K231811Zavation Connector SystemZavation Medical Products, LLC2023—
+2K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.2023—
+2K190361Zavation Spinal SystemZavation Medical Products, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201910
202010
202320
FIG. 1 — Lineage of K112484, 1996–2023Source: 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

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
*K955348Titanium Moss Miami Spinal System
Summary page 2
…he Zavation Spinal System components are manufactured from titanium alloy (Ti-6A1-4V) as described by ASTMV F136. Predicate Device: Depuy Spine Moss Miami Spine System (K955348) Depuy Spine Expedium Spine System (K033901) Technological Characteristics: The Zavation Spinal System possesses the same techno…
Depuy, Inc.1996—
*K033901Merlin Spine System
Summary page 2
…ufactured from titanium alloy (Ti-6A1-4V) as described by ASTMV F136. Predicate Device: Depuy Spine Moss Miami Spine System (K955348) Depuy Spine Expedium Spine System (K033901) Technological Characteristics: The Zavation Spinal System possesses the same technological characteristics as the predicate dev…
Depuy Spine, Inc.2004—

Also cleared against K955348: 33 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K202624Z-Span Plate SystemZavation Medical Products, LLC20201
K153404Zavation Spinal SystemZavation, LLC20161
K231811Zavation Connector SystemZavation Medical Products, LLC20230

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K202624 (Zavation Medical Products, LLC, 2020) has gone furthest, with 1 descendant of its own.
  • 33 other devices also cite its predicate K955348.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The Zavation 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed…

Read the full statement (176 words)

The Zavation 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedlicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

Indications for use as stated in the FDA summary.

Also cleared against K955348

33 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K190376PASS LP Spinal SystemMedicrea International SA · 20195 recalls
  • K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  • K180324Patriot Spinal Fixation SystemValorus Spine · 2018
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
  • K153404Zavation Spinal SystemZavation, LLC · 2016

More from Zavation, LLC

15 FDA decisions under this applicant name. See the company

  • K162206Zavation IBFZavation, LLC · 2017
  • K162575Z-LINKPC SystemZavation, LLC · 2017
  • K162824Z-Span Plate SystemZavation, LLC · 2017
  • K161016Z-Clamp ISP SystemZavation, LLC · 2016
  • K153404Zavation Spinal SystemZavation, LLC · 2016

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K112484 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112484: Zavation Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112484

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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