510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Zodiac Polyaxial Spinal Fixation System

K042673510(k) SpecialCleared Oct 27, 200428-day reviewClass II21 CFR 888.3050Recalls 3

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

Alphatec/Nexmed · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Oct 27, 2004 after a 28-day review. The FDA summary names no predicate by number. 235 later devices descend from it. It has been recalled 3 times.

Decided
Oct 27, 2004
Review
28 days
Class
Class II
Product code
KWP
Recalls
3
Predicates
0

235 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2009: 3 descendants cleared2014: 6 descendants cleared2011: 1 descendant cleared2005: 1 descendant cleared2012: 6 descendants cleared2013: 3 descendants cleared2010: 3 descendants cleared2015: 6 descendants cleared2016: 8 descendants cleared2017: 21 descendants cleared2020: 17 descendants cleared2021: 10 descendants cleared2018: 16 descendants cleared2023: 28 descendants cleared2019: 12 descendants cleared2025: 28 descendants cleared2024: 28 descendants cleared2022: 14 descendants cleared2026: 23 descendants cleared200020052010201520202025
  1. This deviceK042673 Zodiac Polyaxial Spinal Fixation SystemAlphatec/Nexmed · 2004
  2. Descendant · cites it directly · 176 of its ownK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
  3. Descendant · cites it directly · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
  4. Descendant · cites it directly · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
  5. Descendant · 2 generations on · 150 of its ownK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
  6. Descendant · 2 generations on · 84 of its ownK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015

Showing 5 of 235 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12009: 32010: 32011: 12012: 62013: 32014: 62015: 62016: 82017: 212018: 162019: 122020: 172021: 102022: 142023: 282024: 282025: 282026: 23
2005high 28 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 235 · See all
  • K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005 · cites it directly176descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042673Zodiac Polyaxial Spinal Fixation SystemAlphatec/Nexmed2004—
+1K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
200930
201030
201110
201260
201330
201460
201560
201680
2017210
2018160
2019120
2020170
2021100
2022140
2023280
2024280
2025280
2026230
FIG. 1 — Lineage of K042673, 2004–2026Source: 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 KWP? 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (235)

See all 235

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

NumberDeviceApplicantDecidedDescendants
K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed2005176
K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170
K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168
K110321Tiger Spine SystemCorelink, LLC201183
K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219
K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410
K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108
K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093
K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.20132
K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120

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…
Jul 6, 2011Class IIZ-0967-2013Process controlThe rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
Nov 3, 2008Not classifiedZ-0491-2010Error in labelingAlphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051286 (Alphatec/Nexmed, 2005) has gone furthest, with 176 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
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 ZODIAC TMPolyaxial 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 (259 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 ZODIAC TMPolyaxial 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 ZODIAC TM 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 ZODIAC TM 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 ZODIAC TM 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.

More from Alphatec/Nexmed

9 FDA decisions under this applicant name. See the company

  • K050830Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
  • K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
  • K050553Novel VBR Spinal SystemAlphatec/Nexmed · 20051 recall
  • K050390Tamarack Anterior ThoracolunbarAlphatec/Nexmed · 2005
  • K050078Roc Lumbar Plating SystemAlphatec/Nexmed · 2005

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K042673 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042673: Zodiac 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/K042673

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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