510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Polaris Spinal System

K133746510(k) TraditionalCleared Mar 12, 201493-day reviewClass II21 CFR 888.3070Recalls 1

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 Mar 12, 2014 as substantially equivalent to K091445 (Medtronic Sofamor Danek, 2010) and 22 other predicates after a 93-day review. Its family tree reaches back 16 generations to 2001. 1 of the 387 devices in its family, counting itself, has a Class I recall. 67 later devices descend from it. It has been recalled once.

Decided
Mar 12, 2014
Review
93 days
Class
Class II
Product code
NKB
Recalls
1
Predicates
23

Its longest line of descent runs back 16 generations to K003155 (2001). 319 ancestors in all, the oldest K781443 (1978). 67 later devices descend from it, 5 citing it directly. 1 of the 387 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2012: 4 other ancestors2011: 11 other ancestors2010: 16 other ancestors, 1 with a Class I recall12009: 19 other ancestors2008: 19 other ancestors2006: 22 other ancestors2003: 18 other ancestors2002: 16 other ancestors2001: 22 other ancestors2000: 21 other ancestors1998: 12 other ancestors1997: 7 other ancestors1996: 6 other ancestors1991: 1 other ancestor2005: 31 other ancestors2004: 36 other ancestors1995: 6 other ancestors1994: 2 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors2007: 12 other ancestors1999: 9 other ancestors1978: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2015: 4 descendants cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 5 descendants cleared2024: 10 descendants cleared2019: 3 descendants cleared2020: 5 descendants cleared2021: 6 descendants cleared2018: 2 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) ×3: 3 generations cleared close together, K040536 (2004), K041556 (2004), K043561 (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) · 2012×2: 2 generations cleared close together, K123549 (2013), K131615 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 20 other ancestors2 generations back: 61 other ancestors, 1 with a Class I recall13 generations back: 90 other ancestors4 generations back: 76 other ancestors5 generations back: 32 other ancestors6 generations back: 21 other ancestors7 generations back: 1 other ancestor8 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 12 descendants3 generations forward: 15 descendants4 generations forward: 13 descendants5 generations forward: 12 descendants6 generations forward: 7 descendants7 generations forward: 3 descendants K131615 · Polaris Spinal System · Biomet Spine (Aka Ebi, LLC) · 2013K123549 · Polaris Spinal System - Ballista II Percutaneous Screw Placement System · Biomet Spine (Aka Ebi, LLC) · 2013 · recalledK113593 · 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. · 2001−15−10−50+5
  1. Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations between
  3. 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  4. 2 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  5. 1 generation backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  6. This deviceK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014
  7. Descendant · cites it directly · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  8. Descendant · 2 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  9. Descendant · 3 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
  10. Descendant · cites it directly · 19 of its ownK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled
  11. Descendant · cites it directly · 19 of its ownK151422 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
Show all 16 generations
  1. Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 15 generations backK012254 VBROsteotech, Inc. · 2001
  3. 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 7 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 6 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 5 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 4 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 2 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  16. 1 generation backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  17. This deviceK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2014: 12015: 42016: 12017: 52018: 22019: 32020: 52021: 62022: 62023: 82024: 102025: 82026: 8
2014high 10 (2024) · low 1 (2014)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010

Most influential descendants

Showing 5 of 67 · See all
  • K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · cites it directly30descendants
  • K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 2 generations on26descendants
  • K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 3 generations on21descendants
  • K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · cites it directly19descendants
  • K151422Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · cites it directly19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−15K012254VBROsteotech, Inc.2001—
−14K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−13K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−12K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−11K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−7K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−6K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−4K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
−1K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
0 (this device)K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014—
+1K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.2015—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.2017—
+1K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.20153
+1K151422Reform Pedicle Screw SystemPrecision Spine, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199110
199250
199330
199420
199560
199660
199770
1998120
199990
2000210
2001220
2002160
2003180
2004360
2005310
2006220
2007120
2008190
2009190
2010161
2011110
201240

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201540
201610
201750
201820
201930
202050
202160
202260
202380
2024100
202580
202680
FIG. 1 — Lineage of K133746, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

1 device in this family has a Class I recall. 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? (23)

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
*K091445CD Horizon Spinal System
Summary page 2
…s based on the worst-case construct testing. Substantial Equivalence: The Polaris Spinal System is substantially equivalent to the CD Horizon" Spinal System, Medtronic (K09 1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K0…
Medtronic Sofamor Danek2010—
*K111457CD Horizon Spinal System
Summary page 2
…the worst-case construct testing. Substantial Equivalence: The Polaris Spinal System is substantially equivalent to the CD Horizon" Spinal System, Medtronic (K09 1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the…
Medtronic Sofamor Danek2011—
*K113174CD Horizon Spinal System
Summary page 2
…case construct testing. Substantial Equivalence: The Polaris Spinal System is substantially equivalent to the CD Horizon" Spinal System, Medtronic (K09 1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depu…
Medtronic Sofamor Danek USA, Inc.20111
*K964159CD Spinal SystemSofamor Danek USA,Inc.1997—
*K980184CD Spinal SystemSofamor Danek USA,Inc.1998—
*K000476Modification to CD Spinal System
Summary page 2
…ystem is substantially equivalent to the CD Horizon" Spinal System, Medtronic (K09 1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Sp…
Medtronic Sofamor Danek, Inc.2000—
*K120571Synthes Uss Connector
Summary page 2
…quivalent to the CD Horizon" Spinal System, Medtronic (K09 1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31…
Synthes Spine2012—
*K082572Uss Iliosacral, Uss Polyaxial
Summary page 2
…o the CD Horizon" Spinal System, Medtronic (K09 1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 12…
Synthes Spine2008—
*K022949Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss
Summary page 2
…orizon" Spinal System, Medtronic (K09 1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 10…
Synthes (Usa)2003—
*K003822Isola Closed Dual Rod Connector
Summary page 2
…1445, K 111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI…
Depuyacromed2001—
*K022285Modification to Isola Spinal System
Summary page 2
…111457 & K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K9…
Depuyacromed2002—
*K962984Isola Pediatric Components
Summary page 2
…K 113 174) the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K9…
Acromed Corp.1996—
*K905826Isola Slotted Connect/Angled Slotted Connector
Summary page 2
…the CDTM Spinal System, Sofamor Danek (K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in…
Acromed Corp.1991—
*K0902035.5 Helical Flange Spinal System, Polaris Components
Summary page 2
…K9641I59, K9801I84 &K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for…
Ebi, L.P.2009—
*K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
*K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement System
Summary page 2
…&K000476), Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for use, fundamental t…
Biomet Spine (Aka Ebi, LLC)20132
*K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System
Summary page 2
…, Synthes' USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for use, fundamental technology…
Biomet Spine (Aka Ebi, LLC)2010—
*K0910675.5 Polaris Spinal System
Summary page 2
…USS (K 12057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for use, fundamental technology including…
Biomet Spine2009—
*K090523Polaris Spinal System
Summary page 2
…2057 1, K082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for use, fundamental technology including design,…
Ebi, L.P.2009—
*K061441Ebi 5.5 Helical Flange Spinal System
Summary page 2
…082572 & K022949) the Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for use, fundamental technology including design, materials,…
Ebi, L.P.20062
*K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 2
…e Isola, Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing meth…
Cross Medical Products, Inc.1998—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 2
…Depuy & AcroMed (K003822, K022285, K962984 & K905826) and the Polaris Spinal System (K090203, Kl31615, K 123549, K 100409, K091067, K090523, K06144 1, KI 13593, K974749, K950099) in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, ster…
Buckman Co., Inc.1997—

Also cleared against K091445: 26 other devices →

What descends from it? (67)

See all 67

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

NumberDeviceApplicantDecidedDescendants
K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430
K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.201519
K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519
K151974Polaris Spinal SystemBiomet Spine201516
K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 12, 2015Class IIZ-2152-2015Nonconforming Material/ComponentMultiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 9 months on median.
  • 32 of the 319 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K143248 (Precision Spine, Inc., 2014) has gone furthest, with 30 descendants of its own.
  • 26 other devices also cite its predicate K091445.

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. 2014, 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 for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with…

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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 for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: 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, Scheuermann's disease, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista and Cypher MIS instruments are intended to be used with Ballista/Cypher MIS/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.

For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.

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, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega2I 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 K091445

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https://510kreport.com/device/K133746 · printed Nov 5, 2026

Cite this page

510(k) Report. “K133746: Polaris Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133746

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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