510(k) · Cleared
ClearedSynergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 1, 2004 after a 30-day review. The FDA summary names no predicate by number. 284 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
284 later devices descend from it, 11 citing it directly.
- This deviceK041449 Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange…Interpore Cross Intl. · 2004
- Descendant · cites it directly · 255 of its ownK081952 Synergy Spinal System (6.35 Polaris)Biomet Spine · 2008
- Descendant · cites it directly · 156 of its ownK090523 Polaris Spinal SystemEbi, L.P. · 2009
- Descendant · cites it directly · 154 of its ownK090203 5.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009
- Descendant · 2 generations on · 153 of its ownK100220 Polaris Spinal SystemEbi, L.P. · 2010
- Descendant · 2 generations on · 144 of its ownK100409 Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation…Biomet Spine (Aka Ebi, LLC) · 2010
Showing 5 of 284 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 284 · See all- K081952Synergy Spinal System (6.35 Polaris)Biomet Spine · 2008 · cites it directly255descendants
- K090523Polaris Spinal SystemEbi, L.P. · 2009 · cites it directly156descendants
- K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009 · cites it directly154descendants
- K100220Polaris Spinal SystemEbi, L.P. · 2010 · 2 generations on153descendants
- K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC) · 2010 · 2 generations on144descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction… | Interpore Cross Intl. | 2004 | — |
| +1 | K081952 | Synergy Spinal System (6.35 Polaris) | Biomet Spine | 2008 | — |
| +1 | K090523 | Polaris Spinal System | Ebi, L.P. | 2009 | — |
| +1 | K090203 | 5.5 Helical Flange Spinal System, Polaris Components | Ebi, L.P. | 2009 | — |
| +2 | K100220 | Polaris Spinal System | Ebi, L.P. | 2010 | — |
| +2 | K100409 | Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System | Biomet Spine (Aka Ebi, LLC) | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 16 | 0 |
| 2014 | 12 | 0 |
| 2015 | 20 | 0 |
| 2016 | 15 | 0 |
| 2017 | 15 | 0 |
| 2018 | 22 | 0 |
| 2019 | 14 | 0 |
| 2020 | 17 | 0 |
| 2021 | 16 | 0 |
| 2022 | 18 | 0 |
| 2023 | 29 | 0 |
| 2024 | 27 | 0 |
| 2025 | 24 | 0 |
| 2026 | 17 | 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?
The FDA summary names no predicate by number.
What descends from it? (284)
See all 28411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081952 | Synergy Spinal System (6.35 Polaris) | 2008 | 255 |
| K090523 | Polaris Spinal System | 2009 | 156 |
| K090203 | 5.5 Helical Flange Spinal System, Polaris Components | 2009 | 154 |
| K103393 | Polaris Spinal System | 2011 | 104 |
| K100956 | Spondy Spinal Fixation System | 2010 | 17 |
| K190360 | LineSider™ Spinal System | 2019 | 13 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
| K101112 | Reliance Spinal Screw System | 2010 | 7 |
| K131785 | Pagoda Pedicle Screw System | 2013 | 6 |
| K110896 | Reliance Spinal Screw System | 2012 | 5 |
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?
- Of its descendants, K081952 (Biomet Spine, 2008) has gone furthest, with 255 descendants of its own.
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?
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal heating and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. As a…
Read the full statement (451 words)
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal heating and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system, the Synergy Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-SI) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to Sl/Ilium.
In addition, the pedicle screw system may also be used to provide inunobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:
I. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Idiopathic scoliosis.
3. Kyphotic deformities of the spine.
4. Paralytic scoliosis and/or pelvic obliquity.
5. Lordotic deformities of the spine.
6. Neuromuscular scoliosis associated with pelvic obliquity.
7. Vertebral fracture or dislocation.
8. Tumors.
9. Spondylolisthesis.
10- Stenosis.
11. Pseudarthrosis.
12. Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachunent only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.
The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: TI 0 to L3 for the double rod constructs and T5 to L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least I cm from any major vessel
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041449: Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction Seat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041449
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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