510(k) · Cleared
Recalled · Class II · 2010Icon Polyaxial Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Mfg., Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Mar 26, 2004 as substantially equivalent to K031585 (U&I Corp., America, 2003) and 3 other predicates after a 179-day review. Its family tree reaches back 3 generations to 2000. 180 later devices descend from it. It has been recalled once.
- Decided
- Mar 26, 2004
- Review
- 179 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K000319 (2000). 9 ancestors in all, the oldest K982320 (1998). 180 later devices descend from it, 10 citing it directly.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004
- Descendant · cites it directly · 176 of its ownK051286 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
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 180 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| 0 (this device) | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 14 | 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 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? (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 |
|---|---|---|---|
| * | K031585 | U&I, Optima, Spinal SystemSummary page 2…ing predicate devices: Trade/Proprietary Name Manufacturer Clearance Optima Spinal System U&I America K031585 Global Spinal Fixation System U&I America K001668 Moss-Miami Spinal System Depuy Inc.… | 2003 |
| * | K001668 | Global Spinal Fixation SystemSummary page 2…Clearance Optima Spinal System U&I America K031585 Global Spinal Fixation System U&I America K001668 Moss-Miami Spinal System Depuy Inc. K982320 Universal Spine System Synthes… | 2000 |
| * | K982320 | Depuy Motech Moss Miami Spinal SystemSummary page 2…a K031585 Global Spinal Fixation System U&I America K001668 Moss-Miami Spinal System Depuy Inc. K982320 Universal Spine System Synthes K022949 Performance Data: Mechanical and dynamic testing o… | 1998 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 2…a K001668 Moss-Miami Spinal System Depuy Inc. K982320 Universal Spine System Synthes K022949 Performance Data: Mechanical and dynamic testing of the ZODIAC Polyaxial Pedicle Screw System was performed. The test result… | 2003 |
What descends from it? (180)
See all 18010 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051286 | Zodiac Spinal Fixation System | 2005 | 176 |
| K093077 | Zodiac Polyaxial Spinal Fixation System | 2009 | 170 |
| K100685 | Zodiac Polyaxial Spinal Fixation System | 2010 | 168 |
| K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | 2016 | 73 |
| K140678 | Cosmolock Pedicle Screw System | 2014 | 10 |
| K091189 | Zodiac Polyaxial Spinal Fixation System | 2009 | 3 |
| K123623 | Illico Mis Posterior Fixation System | 2013 | 2 |
| 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2010 | Class II | Z-0269-2013 | Error in labeling | The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K051286 (Alphatec/Nexmed, 2005) has gone furthest, with 176 descendants of its own.
- 40 other devices also cite its predicate K031585.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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 Polyaxial Pedicle Screw 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 ZODIAC Polyaxial Pedicle Screw 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 Polyaxial Pedicle Screw 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 Polyaxial Pedicle Screw 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 Polyaxial Pedicle Screw 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/K033090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033090: Icon Polyaxial Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033090
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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