510(k) Report

510(k) · Cleared

Cleared

PERLA® TL Posterior Osteosynthesis System

K213470510(k) TraditionalCleared Jan 21, 202285-day reviewClass II21 CFR 888.3070

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

Spineart · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 21, 2022 as substantially equivalent to K203506 (Spineart, 2021) and 6 other predicates after an 85-day review. Its family tree reaches back 22 generations to 2001. 1 of the 522 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Jan 21, 2022
Review
85 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 22 generations to K003155 (2001). 519 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 1 of the 522 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2021: 1 other ancestor2017: 6 other ancestors2013: 9 other ancestors2009: 28 other ancestors2001: 30 other ancestors2019: 1 other ancestor2015: 8 other ancestors2014: 9 other ancestors2011: 24 other ancestors2010: 30 other ancestors, 1 with a Class I recall12008: 31 other ancestors2007: 20 other ancestors2006: 30 other ancestors2004: 43 other ancestors1995: 10 other ancestors2018: 2 other ancestors2016: 4 other ancestors2012: 15 other ancestors2005: 40 other ancestors2003: 29 other ancestors2002: 28 other ancestors2000: 27 other ancestors1999: 13 other ancestors1998: 19 other ancestors1997: 10 other ancestors1996: 10 other ancestors1991: 1 other ancestor1994: 5 other ancestors1993: 4 other ancestors1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1984: 1 other ancestor1985: 1 other ancestor2023: 1 descendant cleared2026: 1 descendant 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) · 2012×3: 3 generations cleared close together, K123549 (2013), K131615 (2013), K133746 (2014) K143248 · Reform Pedicle Screw System · Precision Spine, Inc. · 2014K150856 · Reform Pedicle Screw System · Precision Spine, Inc. · 2015K173130 · Reform® Midline Cortical Screw System · Precision Spine, Inc. · 2017K193396 · PERLA® TL posterior osteosynthesis system · Spineart · 2020 · recalledK203222 · PERLA TL Posterior Osteosynthesis System · Spineart · 202019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 23 other ancestors3 generations back: 63 other ancestors4 generations back: 81 other ancestors5 generations back: 121 other ancestors, 1 with a Class I recall16 generations back: 113 other ancestors7 generations back: 57 other ancestors8 generations back: 19 other ancestors9 generations back: 12 other ancestors10 generations back: 1 other ancestor11 generations back: 2 other ancestors 1 generation forward: 2 descendants K203222 · PERLA TL Posterior Osteosynthesis System · Spineart · 2020K193396 · PERLA® TL posterior osteosynthesis system · Spineart · 2020 · recalledK173130 · Reform® Midline Cortical Screw System · Precision Spine, Inc. · 2017K150856 · Reform Pedicle Screw System · Precision Spine, Inc. · 2015K143248 · Reform Pedicle Screw System · Precision Spine, Inc. · 2014K133746 · Polaris Spinal System · Biomet Spine (Aka Ebi, LLC) · 2014 · recalledK131615 · 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. · 2001−20−15−10−50
  1. Root · 22 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 18 generations between
  3. 3 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
  4. 2 generations backK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
  5. 1 generation backK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  6. This deviceK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  7. Descendant · cites it directly · 0 of its ownK253966 PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2026
  8. Descendant · cites it directly · 0 of its ownK230774 PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
Show all 22 generations
  1. Root · 22 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 21 generations backK012254 VBROsteotech, Inc. · 2001
  3. 20 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 19 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 18 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 17 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 16 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 15 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 14 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 13 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 12 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 11 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 10 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 9 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 8 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  16. 7 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  17. 6 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  18. 5 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  19. 4 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  20. 3 generations backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
  21. 2 generations backK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
  22. 1 generation backK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  23. This deviceK213470 PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System5 generations back · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA · 2026 · cites it directly0descendants
  • K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−21K012254VBROsteotech, Inc.2001—
−20K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−19K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−18K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−17K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−16K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−15K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−14K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−13K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−12K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−11K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−10K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−9K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−8K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
−7K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
−6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
−5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
−4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.2015—
−3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.2017—
−2K193396PERLA® TL posterior osteosynthesis systemSpineart20202
−1K203222PERLA TL Posterior Osteosynthesis SystemSpineart2020—
0 (this device)K213470PERLA® TL Posterior Osteosynthesis SystemSpineart2022—
+1K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2026—
+1K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199110
199250
199340
199450
1995100
1996100
1997100
1998190
1999130
2000270
2001300
2002280
2003290
2004430
2005400
2006300
2007200
2008310
2009280
2010301
2011240
2012150
201390
201490
201580
201640
201760
201820
201910
202110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202610
FIG. 1 — Lineage of K213470, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K203506PERLA® TL posterior osteosynthesis system
Summary page 4
…Product Line Extension of the PERLA® TL Posterior Osteosynthesis System Basis for submission previously cleared under K193396; K203222; K203506 SPINEART 3 Chemin du Pré Fleuri Submitted by 1228 PLAN LES OUATES…
Spineart20212
*K203222PERLA TL Posterior Osteosynthesis System
Summary page 4
…Product Line Extension of the PERLA® TL Posterior Osteosynthesis System Basis for submission previously cleared under K193396; K203222; K203506 SPINEART 3 Chemin du Pré Fleuri Submitted by 1228 PLAN LE…
Spineart2020—
*K193396PERLA® TL posterior osteosynthesis system
Summary page 4
…ADITIONAL Product Line Extension of the PERLA® TL Posterior Osteosynthesis System Basis for submission previously cleared under K193396; K203222; K203506 SPINEART 3 Chemin du Pré Fleuri Submitted by 122…
Spineart20202
*K172101ROMEO® 2 Posterior Osteosynthesis System
Summary page 4
…PERLA® TL Posterior Osteosynthesis System by Spineart predicate devices (K203222, K193396); ROMEO® 2 Posterior Osteosynthesis System by Spineart (K172101); CD Horizon Spinal System by Medtronic Sofamor Danek USA, Inc (K130646); XIA 3 Spinal System by Stryker Spi…
Spineart2017—
*K130646CD Horizon Spinal System
Summary page 4
…; ROMEO® 2 Posterior Osteosynthesis System by Spineart (K172101); CD Horizon Spinal System by Medtronic Sofamor Danek USA, Inc (K130646); XIA 3 Spinal System by Stryker Spine (K013823, K091291) The PERLA® TL posterior osteosynthesis system is i…
Medtronic Sofamor Danek USA, Inc.2013—
*K013823Xia Spinal System
Summary page 4
…ineart (K172101); CD Horizon Spinal System by Medtronic Sofamor Danek USA, Inc (K130646); XIA 3 Spinal System by Stryker Spine (K013823, K091291) The PERLA® TL posterior osteosynthesis system is intended to provide immobili…
Howmedica Osteonics Corp.2001—
*K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod
Summary page 4
…(K172101); CD Horizon Spinal System by Medtronic Sofamor Danek USA, Inc (K130646); XIA 3 Spinal System by Stryker Spine (K013823, K091291) The PERLA® TL posterior osteosynthesis system is intended to provide immobilization an…
Stryker Spine2009—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260
K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230

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

No FDA recall names this device.

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 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 63 of the 519 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K253966 (Spineart SA, 2026) has gone furthest, with 0 descendants of its own.

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. 2022, 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 PERLA® TL Posterior Osteosynthesis System is intended 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used…

Read the full statement (113 words)

The PERLA® TL Posterior Osteosynthesis System is intended 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Spineart

44 FDA decisions under this applicant name. See the company

  • K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
  • K210472SPINEART Navigation Instrument SystemSpineart · 2021
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  • K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart · 2020

Recent decisions in NKB

The NKB category page

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  • 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/K213470 · printed Nov 4, 2026

Cite this page

510(k) Report. “K213470: PERLA® TL Posterior Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213470

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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