510(k) · Cleared
ClearedPolaris Spinal System-Ballista Spinal Rods
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 Jun 15, 2012 as substantially equivalent to K061441 (Ebi, L.P., 2006) and 6 other predicates after a 63-day review. Its family tree reaches back 14 generations to 1985. 1 later device descends from it.
- Decided
- Jun 15, 2012
- Review
- 63 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K853033 (1985). 80 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK110216 Expedium System, Viper SystemDepuy Spine, Inc. · 2011
- This deviceK121130 Polaris Spinal System-Ballista Spinal RodsBiomet Spine · 2012
- Descendant · cites it directly · 0 of its ownK123451 Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC) · 2012
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK110216 Expedium System, Viper SystemDepuy Spine, Inc. · 2011
- This deviceK121130 Polaris Spinal System-Ballista Spinal RodsBiomet Spine · 2012
Most influential descendants
Showing 1 of 1 · See all- K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | 8 |
| −1 | K110216 | Expedium System, Viper System | Depuy Spine, Inc. | 2011 | — |
| 0 (this device) | K121130 | Polaris Spinal System-Ballista Spinal Rods | Biomet Spine | 2012 | — |
| +1 | K123451 | Polaris Spinal System - Ballista II Rods | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (7)
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 SystemSummary page 2…trumentation. Substantial Equivalence: The Ballista rods in the Polaris Spinal System are substantially equivalent to the other rods in Polaris Spinal System cleared in K061441 as well as the lDepuy Viper System (KI 110216, K03390 1, K090648 & K101 993) and Zimmer Spine's Pathfinder Minimally Invasive Ped… | 2006 |
| * | K110216 | Expedium System, Viper SystemSummary page 2…lista rods in the Polaris Spinal System are substantially equivalent to the other rods in Polaris Spinal System cleared in K061441 as well as the lDepuy Viper System (KI 110216, K03390 1, K090648 & K101 993) and Zimmer Spine's Pathfinder Minimally Invasive Pedicle Screw System (K 100845 & K030625). These… | 2011 |
| * | K033901 | Merlin Spine SystemSummary page 2…ds in the Polaris Spinal System are substantially equivalent to the other rods in Polaris Spinal System cleared in K061441 as well as the lDepuy Viper System (KI 110216, K03390 1, K090648 & K101 993) and Zimmer Spine's Pathfinder Minimally Invasive Pedicle Screw System (K 100845 & K030625). These new rods a… | 2004 |
| * | K090648 | Viper 2 SystemSummary page 2…Polaris Spinal System are substantially equivalent to the other rods in Polaris Spinal System cleared in K061441 as well as the lDepuy Viper System (KI 110216, K03390 1, K090648 & K101 993) and Zimmer Spine's Pathfinder Minimally Invasive Pedicle Screw System (K 100845 & K030625). These new rods are substa… | 2009 |
| * | K101993 | Viper System, Expedium SystemSummary page 2…inal System are substantially equivalent to the other rods in Polaris Spinal System cleared in K061441 as well as the lDepuy Viper System (KI 110216, K03390 1, K090648 & K101 993) and Zimmer Spine's Pathfinder Minimally Invasive Pedicle Screw System (K 100845 & K030625). These new rods are substantially equ… | 2010 |
| * | K100845 | Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesSummary page 2…em cleared in K061441 as well as the lDepuy Viper System (KI 110216, K03390 1, K090648 & K101 993) and Zimmer Spine's Pathfinder Minimally Invasive Pedicle Screw System (K 100845 & K030625). These new rods are substantially equivalent to the predicate rods with. respect to intended use and indications, tech… | 2010 |
| * | K030625 | Spinal Concepts Inc. PathfinderSummary page 2…in K061441 as well as the lDepuy Viper System (KI 110216, K03390 1, K090648 & K101 993) and Zimmer Spine's Pathfinder Minimally Invasive Pedicle Screw System (K 100845 & K030625). These new rods are substantially equivalent to the predicate rods with. respect to intended use and indications, technological… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123451 | Polaris Spinal System - Ballista II Rods | 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 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 80 ancestors have a recall of any class.
- Of its descendants, K123451 (Biomet Spine (Aka Ebi, LLC), 2012) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K061441.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allogaft. The device is indicated for all the following indications…
Read the full statement (319 words)
The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allogaft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity' or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed Previous fusion.
The Ballista instruments are intended to be used with Ballista/Polaris 5.5mmn implants. Cannulated screws and percutaneous rods may be used with the Ballista instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allo graft.
The Polaris Spinal System may be used with the instruments in the Accuision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet Omega2l Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121130: Polaris Spinal System-Ballista Spinal Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121130
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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