510(k) · Cleared
ClearedZodiac Polyaxial Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Dec 23, 2009 as substantially equivalent to K033090 (Alphatec Mfg., Inc., 2004) and 3 other predicates after an 84-day review. Its family tree reaches back 5 generations to 2000. 170 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K000319 (2000). 28 ancestors in all, the oldest K933881 (1994). 170 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 3 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 2 generations backK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- 1 generation backK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- This deviceK093077 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
- Descendant · 3 generations on · 78 of its ownK142499 Reline SystemNu Vasive, Incorporated · 2014
Showing 5 of 170 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 170 · See all- 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
- K142499Reline SystemNu Vasive, Incorporated · 2014 · 3 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −4 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −3 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −2 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| −1 | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| 0 (this device) | 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 | — |
| +3 | K142499 | Reline System | Nu Vasive, Incorporated | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 9 | 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 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
What was it cleared against? (4)
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…roprietary/Model Name Manufacturer 510(k) No. Zodiac" Polyaxial Spinal Fixation System Alphatec Spine, Inc. K033090 Zodiac® Polyaxial Spinal Fixation System Alphatec Spine, Inc. K042673 Zodiac® Stainless Steel Spinal Fixatio… | 2004 |
| * | K042673 | Zodiac Polyaxial Spinal Fixation SystemSummary page 2…ac" Polyaxial Spinal Fixation System Alphatec Spine, Inc. K033090 Zodiac® Polyaxial Spinal Fixation System Alphatec Spine, Inc. K042673 Zodiac® Stainless Steel Spinal Fixation System Alphatec Spine, Inc K05 1286 Zodiac® 4.0 Polyaxial Spinal Fixation… | 2004 |
| * | K051286 | Zodiac Spinal Fixation SystemSummary page 2…ac® Polyaxial Spinal Fixation System Alphatec Spine, Inc. K042673 Zodiac® Stainless Steel Spinal Fixation System Alphatec Spine, Inc K05 1286 Zodiac® 4.0 Polyaxial Spinal Fixation System Alphatec Spine, Inc. K071890 Performance Data: Mechanical and dyna… | 2005 |
| * | K071890 | Zodiac 4.0 Polyaxial Spinal Fixation SystemSummary page 2…c® Stainless Steel Spinal Fixation System Alphatec Spine, Inc K05 1286 Zodiac® 4.0 Polyaxial Spinal Fixation System Alphatec Spine, Inc. K071890 Performance Data: Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness f… | 2007 |
What descends from it? (170)
See all 1703 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K100685 (Alphatec Spine, Inc., 2010) has gone furthest, with 168 descendants of its own.
- 9 other devices also cite its predicate K033090.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zodiac® Polyaxial Spinal Fixation System ig intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of…
Read the full statement (334 words)
The Zodiac® Polyaxial Spinal Fixation System ig intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
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-LS5. Sacral-iliac screw indications are limited to the sacrumn-iliac crest only.
1. The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac 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® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac 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® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving autograft or allograft bone.
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Zodiac® 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, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Jsthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093077: Zodiac Polyaxial 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/K093077
Report an extraction error
Are you the manufacturer?
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