510(k) · Cleared
ClearedZodiac Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec/Nexmed · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 17, 2005 as substantially equivalent to K033090 (Alphatec Mfg., Inc., 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 2000. 176 later devices descend from it.
- Decided
- Jun 17, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000319 (2000). 11 ancestors in all, the oldest K982320 (1998). 176 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 3 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 2 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 1 generation backK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- This deviceK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- Descendant · cites it directly · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- Descendant · cites it directly · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
- Descendant · 2 generations on · 150 of its ownK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 84 of its ownK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · 2 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
Showing 5 of 176 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 176 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −3 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −2 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −1 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| 0 (this device) | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| +1 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| +1 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
| +2 | K133221 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2014 | 2 |
| +2 | K143149 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +2 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 25 | 0 |
| 2024 | 26 | 0 |
| 2025 | 23 | 0 |
| 2026 | 22 | 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 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033090 | Icon Polyaxial Pedicle Screw SystemSummary page 2…quivalence for the ZODIAC T M Spinal Fixation System manufactured from stainless steel material is the same as the ZODIAC Spinal Fixation System previously cleared under K033090 and K042673. Performance Data Performance data were submitted to characterize the ZODIAC T M Spinal Fixation System manufacture… | 2004 |
| * | K042673 | Zodiac Polyaxial Spinal Fixation SystemSummary page 2…or the ZODIAC T M Spinal Fixation System manufactured from stainless steel material is the same as the ZODIAC Spinal Fixation System previously cleared under K033090 and K042673. Performance Data Performance data were submitted to characterize the ZODIAC T M Spinal Fixation System manufactured from stain… | 2004 |
What descends from it? (176)
See all 1766 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093077 | Zodiac Polyaxial Spinal Fixation System | 2009 | 170 |
| K100685 | Zodiac Polyaxial Spinal Fixation System | 2010 | 168 |
| K091189 | Zodiac Polyaxial Spinal Fixation System | 2009 | 3 |
| K100138 | Zodiac Polyaxial Spinal Fixation System | 2010 | 0 |
| K090779 | Zodiac Polyaxial Spinal Fixation System | 2009 | 0 |
| K081158 | Zodic Polyaxial Spinal Fixation System | 2008 | 0 |
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 5 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K093077 (Alphatec Spine, Inc., 2009) has gone furthest, with 170 descendants of its own.
- 9 other devices also cite its predicate K033090.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 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-Lb. Sacral screw indications are limited to the sacrum only. 1) The ZODIAC TM 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 (254 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-Lb. Sacral screw indications are limited to the sacrum only.
1) The ZODIAC TM 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 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 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-Si) vertebral joint.
4) The ZODIAC T 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.
https://510kreport.com/device/K051286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051286: Zodiac Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051286
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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