510(k) · Cleared
ClearedSynergy Spinal System (6.35 Polaris)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 7, 2008 as substantially equivalent to K061441 (Ebi, L.P., 2006) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 2004. 255 later devices descend from it.
- Decided
- Oct 7, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K041449 (2004). 3 ancestors in all. 255 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK041449 Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange…Interpore Cross Intl. · 2004
- This deviceK081952 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
- Descendant · cites it directly · 138 of its ownK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
Showing 5 of 255 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 255 · See all- 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
- K120291OP Spine SystemOrthoPediatrics Corp. · 2012 · cites it directly138descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction… | Interpore Cross Intl. | 2004 | — |
| 0 (this device) | 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 | — |
| +1 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 14 | 0 |
| 2014 | 12 | 0 |
| 2015 | 18 | 0 |
| 2016 | 12 | 0 |
| 2017 | 15 | 0 |
| 2018 | 19 | 0 |
| 2019 | 13 | 0 |
| 2020 | 15 | 0 |
| 2021 | 14 | 0 |
| 2022 | 18 | 0 |
| 2023 | 25 | 0 |
| 2024 | 26 | 0 |
| 2025 | 23 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K061441 | Ebi 5.5 Helical Flange Spinal System | 2006 |
| * | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatSummary page 2…gical characteristics, and principles of operation and do not present any new issues of safety or effectiveness. Example of predicates include Synergy Spinal (KO61441and K041449) and the Array Spinal System (K061563).Based upon the mechanical testing, the Synergy Spinal System is substantially equivalent f… | 2004 |
| * | K061563 | Ebi Array Spinal SystemSummary page 2…of operation and do not present any new issues of safety or effectiveness. Example of predicates include Synergy Spinal (KO61441and K041449) and the Array Spinal System (K061563).Based upon the mechanical testing, the Synergy Spinal System is substantially equivalent for its intended use to other spinal sy… | 2006 |
What descends from it? (255)
See all 2556 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090523 | Polaris Spinal System | 2009 | 156 |
| K090203 | 5.5 Helical Flange Spinal System, Polaris Components | 2009 | 154 |
| K120291 | OP Spine System | 2012 | 138 |
| K103393 | Polaris Spinal System | 2011 | 104 |
| K132644 | Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa… | 2013 | 0 |
| K070385 | TI-Tamed Spinal System | 2009 | 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?
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing 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 (447 words)
The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing 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-S1) 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 SI/Ilium.
In addition, the pedicle screw system may also be used to provide immobilization 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:
1. 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 attachment 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: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75mm diameter rod system can be used in single and double rod constructs while the 6.35mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1cm from any major vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081952 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081952: Synergy Spinal System (6.35 Polaris).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081952
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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