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. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jun 18, 2010 as substantially equivalent to K033090 (Alphatec Mfg., Inc., 2004) and 4 other predicates after a 100-day review. Its family tree reaches back 6 generations to 2000. 168 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 100 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K000319 (2000). 29 ancestors in all, the oldest K933881 (1994). 168 later devices descend from it, 8 citing it directly.
- Root · 6 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 5 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 4 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 3 generations backK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- 2 generations backK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- 1 generation backK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- This deviceK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
- Descendant · cites it directly · 150 of its ownK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
- Descendant · cites it directly · 84 of its ownK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · cites it directly · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · 2 generations on · 78 of its ownK142499 Reline SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 77 of its ownK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
Showing 5 of 168 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 168 · See all- K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · cites it directly150descendants
- K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · cites it directly84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · cites it directly83descendants
- K142499Reline SystemNu Vasive, Incorporated · 2014 · 2 generations on78descendants
- K143684NuVasive Reline SystemNu Vasive, Incorporated · 2015 · 3 generations on77descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −5 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −4 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −3 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| −2 | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| −1 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| 0 (this device) | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
| +1 | K133221 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2014 | 2 |
| +1 | K143149 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +1 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +2 | K142499 | Reline System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
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 |
|---|---|---|
| 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 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
What was it cleared against? (5)
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…prietary/Model Namne Manufacturer 510(k) No. Zodiacex Polyaxial Spinal Fixation System Aiphatec Spine, Inc. K033090 Zodiac`®' Polyaxial Spinal Fixation System Aiphatec Spine, Inc. K(042673 Zodac® Stainless Steel Spinal Fixat… | 2004 |
| * | K042673 | Zodiac Polyaxial Spinal Fixation SystemSummary page 2…Polyaxial Spinal Fixation System Aiphatec Spine, Inc. K033090 Zodiac`®' Polyaxial Spinal Fixation System Aiphatec Spine, Inc. K(042673 Zodac® Stainless Steel Spinal Fixation System Aiphatec Spine. Inc K05 1286 Zodiac® 4.0 Polyaxial Spinal Fixatio… | 2004 |
| * | K051286 | Zodiac Spinal Fixation SystemSummary page 2…®' Polyaxial Spinal Fixation System Aiphatec Spine, Inc. K(042673 Zodac® Stainless Steel Spinal Fixation System Aiphatec Spine. Inc K05 1286 Zodiac® 4.0 Polyaxial Spinal Fixation System Alphatec Spine, Inc. K071890 Zodiac® Polyaxial Spinal Fixation Sys… | 2005 |
| * | K071890 | Zodiac 4.0 Polyaxial Spinal Fixation SystemSummary page 2…Stainless Steel Spinal Fixation System Aiphatec Spine. Inc K05 1286 Zodiac® 4.0 Polyaxial Spinal Fixation System Alphatec Spine, Inc. K071890 Zodiac® Polyaxial Spinal Fixation System Alphatec Spine, Inc. K(093077 Performance Data: Mechanical and dy… | 2007 |
| * | K093077 | Zodiac Polyaxial Spinal Fixation SystemSummary page 2…4.0 Polyaxial Spinal Fixation System Alphatec Spine, Inc. K071890 Zodiac® Polyaxial Spinal Fixation System Alphatec Spine, Inc. K(093077 Performance Data: Mechanical and dynamic testing was perfbrnined which provides reasonable assurance of safety and effectiveness… | 2009 |
What descends from it? (168)
See all 1688 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133221 | Arsenal Spinal Fixation System | 2014 | 150 |
| K143149 | Arsenal Spinal Fixation System | 2015 | 84 |
| K152968 | Arsenal Spinal Fixation System | 2015 | 83 |
| K161363 | Arsenal Spinal Fixation System | 2016 | 75 |
| K140678 | Cosmolock Pedicle Screw System | 2014 | 10 |
| K161516 | G Surgical Marksman MIS System | 2016 | 3 |
| K163096 | GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System | 2017 | 0 |
| K111634 | Xenon (TM) Pedicle Screw System | 2012 | 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 10 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 29 ancestors have a recall of any class.
- Of its descendants, K133221 (Alphatec Spine, Inc., 2014) has gone furthest, with 150 descendants of its own.
- 9 other devices also cite its predicate K033090.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zodiac® Polyaxial Spinal Fixation System is 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 is 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-L5. Sacral-iliac screw indications are limited to the sacrum-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. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100685 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100685: Zodiac Polyaxial Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100685
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