510(k) Report

510(k) · Cleared

Cleared

Reform Pedicle Screw System

K143248510(k) TraditionalCleared Dec 19, 201437-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

Precision Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 19, 2014 as substantially equivalent to K131343 (Spinal USA, 2013) and 8 other predicates after a 37-day review. Its family tree reaches back 17 generations to 2001. 1 of the 380 devices in its family, counting itself, has a Class I recall. 30 later devices descend from it.

Decided
Dec 19, 2014
Review
37 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
9

Its longest line of descent runs back 17 generations to K003155 (2001). 349 ancestors in all, the oldest K781443 (1978). 30 later devices descend from it, 3 citing it directly. 1 of the 380 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 2 other ancestors2012: 5 other ancestors2009: 21 other ancestors2008: 22 other ancestors2007: 15 other ancestors2011: 12 other ancestors2010: 17 other ancestors, 1 with a Class I recall12006: 24 other ancestors2003: 19 other ancestors2002: 17 other ancestors2001: 24 other ancestors2000: 23 other ancestors1999: 10 other ancestors1998: 14 other ancestors1997: 7 other ancestors1996: 6 other ancestors1991: 1 other ancestor2005: 34 other ancestors2004: 36 other ancestors1995: 7 other ancestors1994: 2 other ancestors1993: 4 other ancestors1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2015: 2 descendants cleared2017: 2 descendants cleared2020: 3 descendants cleared2024: 4 descendants cleared2018: 1 descendant cleared2022: 3 descendants cleared2023: 5 descendants cleared2021: 2 descendants cleared2026: 5 descendants cleared2025: 3 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) · 2012×3: 3 generations cleared close together, K123549 (2013), K131615 (2013), K133746 (2014) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 27 other ancestors3 generations back: 73 other ancestors, 1 with a Class I recall14 generations back: 110 other ancestors5 generations back: 64 other ancestors6 generations back: 30 other ancestors7 generations back: 18 other ancestors8 generations back: 1 other ancestor9 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 7 descendants4 generations forward: 8 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant K133746 · 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. · 2001−15−10−50+5
  1. Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 13 generations between
  3. 3 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  4. 2 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  5. 1 generation backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  6. This deviceK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  7. Descendant · cites it directly · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  8. Descendant · 2 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
  9. Descendant · cites it directly · 19 of its ownK151422 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  10. Descendant · 2 generations on · 10 of its ownK200303 Reform Pedicle Screw SystemPrecision Spine · 2020
  11. Descendant · cites it directly · 9 of its ownK172101 ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017
Show all 17 generations
  1. Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 16 generations backK012254 VBROsteotech, Inc. · 2001
  3. 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 8 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 7 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 6 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 5 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 4 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 3 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  16. 2 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  17. 1 generation backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  18. This deviceK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2015: 22017: 22018: 12020: 32021: 22022: 32023: 52024: 42025: 32026: 5
2015high 5 (2023) · low 0 (2016)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System3 generations back · 2010

Most influential descendants

Showing 5 of 30 · See all
  • K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · cites it directly26descendants
  • K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 2 generations on21descendants
  • K151422Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · cites it directly19descendants
  • K200303Reform Pedicle Screw SystemPrecision Spine · 2020 · 2 generations on10descendants
  • K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017 · cites it directly9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−16K012254VBROsteotech, Inc.2001—
−15K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−14K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−13K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−12K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−11K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−8K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−7K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−6K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−4K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
−2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
−1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
0 (this device)K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
+1K150856Reform Pedicle Screw SystemPrecision Spine, Inc.2015—
+2K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.2017—
+1K151422Reform Pedicle Screw SystemPrecision Spine, Inc.2015—
+2K200303Reform Pedicle Screw SystemPrecision Spine2020—
+1K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199110
199250
199340
199420
199570
199660
199770
1998140
1999100
2000230
2001240
2002170
2003190
2004360
2005340
2006240
2007150
2008220
2009210
2010171
2011120
201250
201320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201720
201810
202030
202120
202230
202350
202440
202530
202650
FIG. 1 — Lineage of K143248, 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? (9)

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
*K131343Reform Pedicle Screw System
Summary page 5
…he purpose of this submission is to make modifications to the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438. INDICATIONS FOR USE The Reform Pedicle Screw System is intended to…
Spinal USA2013—
*K130279Reform Pedicle Screw System
Summary page 5
…e of this submission is to make modifications to the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438. INDICATIONS FOR USE The Reform Pedicle Screw System is intended to provide i…
Spinal USA2013—
*K121172Reform Pedicle Screw System
Summary page 5
…submission is to make modifications to the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438. INDICATIONS FOR USE The Reform Pedicle Screw System is intended to provide immobiliza…
Spinal USA2012—
*K092128Modification to: PSS System
Summary page 5
…on is to make modifications to the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438. INDICATIONS FOR USE The Reform Pedicle Screw System is intended to provide immobilization and…
Spinal USA2009—
*K090033Modification to: PSS System
Summary page 5
…make modifications to the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438. INDICATIONS FOR USE The Reform Pedicle Screw System is intended to provide immobilization and stabiliza…
Spinal USA2009—
*K073240PSS System
Summary page 5
…fications to the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438. INDICATIONS FOR USE The Reform Pedicle Screw System is intended to provide immobilization and stabilization of s…
Spinal USA2008—
*K071438PSS System
Summary page 5
…the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438. INDICATIONS FOR USE The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal segment…
Spinal USA2007—
*K133746Polaris Spinal System
Summary page 6
…devices, which are the PSS System (Reform Pedicle Screw System, K131343, K130279, K121172, K092128, K090033, K073240, and K071438) and the Biomet Polaris Spinal System (K133746, K131615). The predicate devices and the subject additions to the PSS (Reform) system are designed for posterior stabilization to…
Biomet Spine (Aka Ebi, LLC)20141
*K131615Polaris Spinal System
Summary page 6
…which are the PSS System (Reform Pedicle Screw System, K131343, K130279, K121172, K092128, K090033, K073240, and K071438) and the Biomet Polaris Spinal System (K133746, K131615). The predicate devices and the subject additions to the PSS (Reform) system are designed for posterior stabilization to provide…
Biomet Spine (Aka Ebi, LLC)2013—

Also cleared against K131343: 2 other devices →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526
K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519
K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179

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 · 3 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 6 companies; a new generation was cleared every 9 months on median.
  • 33 of the 349 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K150856 (Precision Spine, Inc., 2015) has gone furthest, with 26 descendants of its own.
  • 2 other devices also cite its predicate K131343.

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 Reform Pedicle Screw 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion…

Read the full statement (235 words)

The Reform Pedicle Screw 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K131343

2 other devices cite the same predicate.

  • K151422Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  • K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015

More from Precision Spine, Inc.

24 FDA decisions under this applicant name. See the company

  • K250769Dakota LP SystemPrecision Spine, Inc. · 2025
  • K242297Reform Pedicle Screw SystemPrecision Spine, Inc. · 2024
  • K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc. · 2023
  • K220862E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
  • K213118Dakota ALIF SystemPrecision Spine, Inc. · 2022

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/K143248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143248: Reform Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143248

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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