510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Zodiac 4.0 Polyaxial Spinal Fixation System

K071890510(k) TraditionalCleared Nov 9, 2007123-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

Alphatec Spine, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Nov 9, 2007 as substantially equivalent to K030383 (Depuyacromed, 2003) after a 123-day review. Its family tree reaches back 4 generations to 1995. 180 later devices descend from it. It has been recalled once.

Decided
Nov 9, 2007
Review
123 days
Class
Class II
Product code
MNH
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to K951116 (1995). 16 ancestors in all, the oldest K933881 (1994). 180 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1998: 3 other ancestors1996: 3 other ancestors1997: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor2008: 1 descendant cleared2018: 10 descendants cleared2009: 3 descendants cleared2012: 1 descendant cleared2014: 5 descendants cleared2013: 1 descendant cleared2010: 2 descendants cleared2015: 3 descendants cleared2016: 5 descendants cleared2017: 12 descendants cleared2023: 25 descendants cleared2019: 9 descendants cleared2020: 10 descendants cleared2024: 27 descendants cleared2021: 9 descendants cleared2022: 12 descendants cleared2026: 22 descendants cleared2025: 23 descendants clearedK951116 · Acromed Pedicle Screw · Acromed Corp. · 1995K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K030383 · Modification to Moss Miami Spinal System Polyaxial Screws · Depuyacromed · 20031990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 6 other ancestors3 generations back: 6 other ancestors 1 generation forward: 11 descendants2 generations forward: 15 descendants3 generations forward: 22 descendants4 generations forward: 16 descendants5 generations forward: 17 descendants6 generations forward: 29 descendants7 generations forward: 25 descendants8 generations forward: 14 descendants9 generations forward: 17 descendants10 generations forward: 12 descendants11 generations forward: 2 descendants K030383 · Modification to Moss Miami Spinal System Polyaxial Screws · Depuyacromed · 2003K982511 · Depuy Motech Moss Miami Spinal Systems · Depuy, Inc. · 1998K963639 · Acromed Pedicle Screw · Acromed Corp. · 1996K951116 · Acromed Pedicle Screw · Acromed Corp. · 19950+5+10
  1. Root · 4 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
  2. 3 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
  3. 2 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
  4. 1 generation backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  5. This deviceK071890 Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2007
  6. Descendant · cites it directly · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
  7. Descendant · cites it directly · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
  8. Descendant · 2 generations on · 150 of its ownK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
  9. Descendant · 2 generations on · 84 of its ownK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  10. Descendant · 2 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015

Showing 5 of 180 descendants. See all descendants

Descendants cleared per year

2008: 12009: 32010: 22012: 12013: 12014: 52015: 32016: 52017: 122018: 102019: 92020: 102021: 92022: 122023: 252024: 272025: 232026: 22
2008high 27 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 180 · See all
  • K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009 · cites it directly170descendants
  • K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010 · cites it directly168descendants
  • K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · 2 generations on150descendants
  • K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 2 generations on84descendants
  • K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 2 generations on83descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K951116Acromed Pedicle ScrewAcromed Corp.1995—
−3K963639Acromed Pedicle ScrewAcromed Corp.1996—
−2K982511Depuy Motech Moss Miami Spinal SystemsDepuy, Inc.1998—
−1K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003—
0 (this device)K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2007—
+1K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009—
+1K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010—
+2K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20142
+2K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199630
199710
199830
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200930
201020
201210
201310
201450
201530
201650
2017120
2018100
201990
2020100
202190
2022120
2023250
2024270
2025230
2026220
FIG. 1 — Lineage of K071890, 1995–2026Source: 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 MNH? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K030383Modification to Moss Miami Spinal System Polyaxial Screws
Summary page 2
…devices: Trade/Proprietary Name Manufacturer Clearance MOSS Miami Spinal DePuy Spine, Inc. K030383 Fixation System Performance Data: Mechanical and dynamic testing of the polyaxial spinal fixation system was performed. The…
Depuyacromed2003—

Also cleared against K030383: 22 other devices →

What descends from it? (180)

See all 180

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

NumberDeviceApplicantDecidedDescendants
K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170
K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168
K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870
K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410
K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143
K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093
K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.20132
K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120
K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100
K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 25, 2012Class IIZ-0168-2013Nonconforming Material/ComponentThe firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
  • None of the 16 ancestors has a recall.
  • Of its descendants, K093077 (Alphatec Spine, Inc., 2009) has gone furthest, with 170 descendants of its own.
  • 22 other devices also cite its predicate K030383.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only. 1) The ZODIACTM Polyaxial Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for: a. Patients having fractures of the thoracic and lumbar spine. b. Patients having deformity (i.e.…

Read the full statement (256 words)

It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1) The ZODIACTM Polyaxial Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine.

b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).

c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

2) The ZODIACTM Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

3) In addition, the ZODIACTM Polyaxial Spinal Fixation System, when used as a pedicle screw fixation system is intended for:

a. Patients receiving only autogenous bone graft.

b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

4) The ZODIACTM Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).

c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

Indications for use as stated in the FDA summary.

Also cleared against K030383

22 other devices cite the same predicate.

  • K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. · 2024
  • K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical · 2020
  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
  • K160926F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016
  • K141291Vertiform Posterior Fixation SystemNext Orthosurgical · 2014

More from Alphatec Spine, Inc.

96 FDA decisions under this applicant name. See the company

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. · 2026

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K071890 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071890: Zodiac 4.0 Polyaxial Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071890

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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