510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Polaris Spinal System - Ballista II Percutaneous Screw Placement System

K123549510(k) TraditionalCleared Feb 25, 201398-day reviewClass II21 CFR 888.3070Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Spine (Aka Ebi, LLC) · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Feb 25, 2013 as substantially equivalent to K061441 (Ebi, L.P., 2006) and 9 other predicates after a 98-day review. Its family tree reaches back 14 generations to 2001. 75 later devices descend from it. It has been recalled 2 times.

Decided
Feb 25, 2013
Review
98 days
Class
Class II
Product code
NKB
Recalls
2
Predicates
10

Its longest line of descent runs back 14 generations to K003155 (2001). 267 ancestors in all, the oldest K841189 (1984). 75 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 6 other ancestors2010: 10 other ancestors2009: 16 other ancestors2006: 21 other ancestors2008: 17 other ancestors2007: 9 other ancestors2005: 29 other ancestors2004: 34 other ancestors2003: 16 other ancestors2002: 14 other ancestors2001: 20 other ancestors2000: 19 other ancestors1999: 9 other ancestors1998: 8 other ancestors1997: 5 other ancestors1995: 4 other ancestors1996: 3 other ancestors1994: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1985: 1 other ancestor1984: 1 other ancestor2014: 4 descendants cleared2018: 4 descendants cleared2013: 1 descendant cleared2016: 1 descendant cleared2015: 4 descendants cleared2021: 6 descendants cleared2017: 5 descendants cleared2024: 10 descendants cleared2019: 3 descendants cleared2020: 7 descendants cleared2022: 6 descendants cleared2023: 8 descendants cleared2026: 8 descendants cleared2025: 8 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 44 other ancestors3 generations back: 74 other ancestors4 generations back: 63 other ancestors5 generations back: 41 other ancestors6 generations back: 13 other ancestors7 generations back: 7 other ancestors8 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 12 descendants4 generations forward: 15 descendants5 generations forward: 13 descendants6 generations forward: 12 descendants7 generations forward: 7 descendants8 generations forward: 3 descendants K113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50+5
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations between
  3. 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  4. 2 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  5. 1 generation backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  6. This deviceK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013
  7. Descendant · cites it directly · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  8. Descendant · cites it directly · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  9. Descendant · 2 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  10. Descendant · 3 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  11. Descendant · cites it directly · 22 of its ownK140123 Polaris Spinal System -Translation ScrewEbi, LLC · 2014 · Recalled
Show all 14 generations
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 13 generations backK012254 VBROsteotech, Inc. · 2001
  3. 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 5 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 4 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 2 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 1 generation backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. This deviceK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2013: 12014: 42015: 42016: 12017: 52018: 42019: 32020: 72021: 62022: 62023: 82024: 102025: 82026: 8
2013high 10 (2024) · low 1 (2013)2026

Most influential descendants

Showing 5 of 75 · See all
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · cites it directly70descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly67descendants
  • K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 2 generations on30descendants
  • K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 3 generations on26descendants
  • K140123Polaris Spinal System -Translation ScrewEbi, LLC · 2014 · cites it directly22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−13K012254VBROsteotech, Inc.2001—
−12K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−11K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−9K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−5K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−4K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−3K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
0 (this device)K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013—
+1K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.2015—
+1K140123Polaris Spinal System -Translation ScrewEbi, LLC20141

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199020
199250
199320
199410
199540
199630
199750
199880
199990
2000190
2001200
2002140
2003160
2004340
2005290
2006210
200790
2008170
2009160
2010100
201160
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201440
201540
201610
201750
201840
201930
202070
202160
202260
202380
2024100
202580
202680
FIG. 1 — Lineage of K123549, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K061441Ebi 5.5 Helical Flange Spinal System
Summary page 2
…nstruct testing. Substantial Equivalence: The subject components in the Polaris Spinal System are substantially equivalent to the other screws in Polaris Spinal System (K061441, K090203 & 111957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD H…
Ebi, L.P.20062
*K0902035.5 Helical Flange Spinal System, Polaris Components
Summary page 2
…esting. Substantial Equivalence: The subject components in the Polaris Spinal System are substantially equivalent to the other screws in Polaris Spinal System (K061441, K090203 & 111957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD Horizon" S…
Ebi, L.P.2009—
*K111957Polaris Spinal System
Summary page 2
…ubstantial Equivalence: The subject components in the Polaris Spinal System are substantially equivalent to the other screws in Polaris Spinal System (K061441, K090203 & 111957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD Horizon" SoleraTm S…
Biomet Spine (Ebi, LLC)2011—
*K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
*K120270Venus Spinal Fixation System
Summary page 2
…e substantially equivalent to the other screws in Polaris Spinal System (K061441, K090203 & 111957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD Horizon" SoleraTm Spinal System (K1 13174, KI 12473 & K102555.) The proposed screws are substantia…
L&K BIOMED Co., Ltd.2012—
*K100706Venus Basic Spinal Fixation System
Summary page 2
…tially equivalent to the other screws in Polaris Spinal System (K061441, K090203 & 111957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD Horizon" SoleraTm Spinal System (K1 13174, KI 12473 & K102555.) The proposed screws are substantially equiv…
L&K BIOMED Co., Ltd.2010—
*K103085Venus Basic Spinal Fixation System
Summary page 2
…ivalent to the other screws in Polaris Spinal System (K061441, K090203 & 111957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD Horizon" SoleraTm Spinal System (K1 13174, KI 12473 & K102555.) The proposed screws are substantially equivalent to t…
L&K BIOMED Co., Ltd.2011—
*K113174CD Horizon Spinal System
Summary page 2
…(K061441, K090203 & 111957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD Horizon" SoleraTm Spinal System (K1 13174, KI 12473 & K102555.) The proposed screws are substantially equivalent to the predicate systems with respect to intended use and…
Medtronic Sofamor Danek USA, Inc.20111
*K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
*K102555CD Horizon Spinal System
Summary page 2
…11957), the Nextgen OCT System (KI 13593), the Venus Spinal Fixation System (K120270, K100706 & K103085) and the CD Horizon" SoleraTm Spinal System (K1 13174, KI 12473 & K102555.) The proposed screws are substantially equivalent to the predicate systems with respect to intended use and indications, materia…
Medtronic Sofamor Danek USA, Inc.2010—

Also cleared against K061441: 8 other devices →

What descends from it? (75)

See all 75

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370
K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201467
K140123Polaris Spinal System -Translation ScrewEbi, LLC201422
K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183
K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 8, 2014Class IIZ-0909-2015Device DesignInoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Aug 22, 2013Class IIZ-0359-2014Device DesignPolaris Translation Screw Failures were recently reported to Biomet Spine. These failures are generally described as dissociation of the screw head from the shaft of the Polaris Translation Screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 10 months on median.
  • 24 of the 267 ancestors have a recall of any class.
  • Of its descendants, K131615 (Biomet Spine (Aka Ebi, LLC), 2013) has gone furthest, with 70 descendants of its own.
  • 8 other devices also cite its predicate K061441.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

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 ailograft. The device is indicated for all the following indications…

Read the full statement (322 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 ailograft. 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/Ballista 11 instruments are intended to be used with Ballista/Ballista Il/Polaris 5.5mmn implants. Cannulated screws and percutaneous rods may be used with the Ballista/Ballista 11 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 allograft.

The Polaris Spinal System may be used with the instruments in the AccuVision 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 Omega2 1 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.

Also cleared against K061441

8 other devices cite the same predicate.

  • K140123Polaris Spinal System -Translation ScrewEbi, LLC · 20141 recall
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 20141 recall
  • K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC) · 2012
  • K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine · 2012
  • K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009
  • K0910675.5 Polaris Spinal SystemBiomet Spine · 2009

More from Biomet Spine (Aka Ebi, LLC)

13 FDA decisions under this applicant name. See the company

  • K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 20141 recall
  • K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC) · 2014
  • K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 20141 recall
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K123549 · printed Nov 4, 2026

Cite this page

510(k) Report. “K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123549

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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