510(k) Report

510(k) · Cleared

Cleared

Reform Pedicle Screw System

K151422510(k) TraditionalCleared Aug 21, 201585-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 Aug 21, 2015 as substantially equivalent to K143248 (Precision Spine, Inc., 2014) and 10 other predicates after an 85-day review. Its family tree reaches back 18 generations to 2001. 1 of the 388 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it.

Decided
Aug 21, 2015
Review
85 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
11

Its longest line of descent runs back 18 generations to K003155 (2001). 368 ancestors in all, the oldest K781443 (1978). 19 later devices descend from it, 2 citing it directly. 1 of the 388 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2014: 2 other ancestors2013: 2 other ancestors2012: 6 other ancestors2009: 23 other ancestors2008: 23 other ancestors2007: 17 other ancestors2011: 15 other ancestors2010: 18 other ancestors, 1 with a Class I recall12006: 24 other ancestors2003: 20 other ancestors2002: 17 other ancestors2001: 27 other ancestors2000: 23 other ancestors1999: 11 other ancestors1998: 14 other ancestors1997: 8 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 ancestor2020: 3 descendants cleared2024: 3 descendants cleared2022: 2 descendants cleared2023: 3 descendants cleared2021: 1 descendant cleared2026: 4 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) · 2012×2: 2 generations cleared close together, K123549 (2013), K131615 (2013) ×2: 2 generations cleared close together, K140123 (2014), K141804 (2014) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 28 other ancestors3 generations back: 77 other ancestors, 1 with a Class I recall14 generations back: 119 other ancestors5 generations back: 68 other ancestors6 generations back: 31 other ancestors7 generations back: 15 other ancestors8 generations back: 1 other ancestor9 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 6 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K141804 · Polaris Spinal System - HA Coated · Biomet Spine, LLC · 2014K140123 · Polaris Spinal System -Translation Screw · 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 · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 14 generations between
  3. 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  4. 2 generations backK140123 Polaris Spinal System -Translation ScrewEbi, LLC · 2014 · Recalled
  5. 1 generation backK141804 Polaris Spinal System - HA CoatedBiomet Spine, LLC · 2014
  6. This deviceK151422 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  7. Descendant · cites it directly · 10 of its ownK200303 Reform Pedicle Screw SystemPrecision Spine · 2020
  8. Descendant · 2 generations on · 7 of its ownK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
  9. Descendant · cites it directly · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
  10. Descendant · 2 generations on · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  11. Descendant · 3 generations on · 3 of its ownK232044 Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023
Show all 18 generations
  1. Root · 18 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 17 generations backK012254 VBROsteotech, Inc. · 2001
  3. 16 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 15 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 14 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 13 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 12 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 11 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 10 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 9 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 8 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 7 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 6 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 5 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 4 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  16. 3 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  17. 2 generations backK140123 Polaris Spinal System -Translation ScrewEbi, LLC · 2014 · Recalled
  18. 1 generation backK141804 Polaris Spinal System - HA CoatedBiomet Spine, LLC · 2014
  19. This deviceK151422 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2020: 32021: 12022: 22023: 32024: 32025: 32026: 4
2020high 4 (2026) · low 1 (2021)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System3 generations back · 2010

Most influential descendants

Showing 5 of 19 · See all
  • K200303Reform Pedicle Screw SystemPrecision Spine · 2020 · cites it directly10descendants
  • K220862E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022 · 2 generations on7descendants
  • K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · cites it directly7descendants
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · 2 generations on4descendants
  • K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−17K012254VBROsteotech, Inc.2001—
−16K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−15K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−14K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−13K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−12K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−11K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−9K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−8K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−7K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−5K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
−3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
−2K140123Polaris Spinal System -Translation ScrewEbi, LLC20141
−1K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC2014—
0 (this device)K151422Reform Pedicle Screw SystemPrecision Spine, Inc.2015—
+1K200303Reform Pedicle Screw SystemPrecision Spine2020—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.2022—
+1K193396PERLA® TL posterior osteosynthesis systemSpineart20202
+2K203222PERLA TL Posterior Osteosynthesis SystemSpineart2020—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199110
199250
199340
199420
199570
199660
199780
1998140
1999110
2000230
2001270
2002170
2003200
2004360
2005340
2006240
2007170
2008230
2009230
2010181
2011150
201260
201320
201420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202030
202110
202220
202330
202430
202530
202640
FIG. 1 — Lineage of K151422, 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? (11)

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
*K143248Reform Pedicle Screw System
Summary page 5
…g. CHANGE FROM PREDICATE: The purpose of this submission is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438.…
Precision Spine, Inc.2014—
*K131343Reform Pedicle Screw System
Summary page 5
…E FROM PREDICATE: The purpose of this submission is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438.…
Spinal USA2013—
*K130279Reform Pedicle Screw System
Summary page 5
…EDICATE: The purpose of this submission is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438.…
Spinal USA2013—
*K121172Reform Pedicle Screw System
Summary page 5
…The purpose of this submission is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438.…
Spinal USA2012—
*K092128Modification to: PSS System
Summary page 5
…ose of this submission is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438. K151422…
Spinal USA2009—
*K090033Modification to: PSS System
Summary page 5
…is submission is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438. K151422 - page 2…
Spinal USA2009—
*K073240PSS System
Summary page 5
…sion is to add hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438. K151422 - page 2 of 3…
Spinal USA2008—
*K071438PSS System
Summary page 5
…d hydroxyapatite (HA) coated pedicle screws to the PSS System (Reform Pedicle Screw System) cleared in K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438. K151422 - page 2 of 3 INDICATIONS F…
Spinal USA2007—
*K141804Polaris Spinal System - HA Coated
Summary page 6
…which are the PSS System (Reform Pedicle Screw System, K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438) and the Biomet Polaris Spinal System (K141804, K133746, K131615). The predicate devices and the subject addition to the PSS (Reform) system is designed for posterior stabiliza…
Biomet Spine, LLC2014—
*K133746Polaris Spinal System
Summary page 6
…e the PSS System (Reform Pedicle Screw System, K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438) and the Biomet Polaris Spinal System (K141804, K133746, K131615). The predicate devices and the subject addition to the PSS (Reform) system is designed for posterior stabilization to p…
Biomet Spine (Aka Ebi, LLC)20141
*K131615Polaris Spinal System
Summary page 6
…System (Reform Pedicle Screw System, K143248, K131343, K130279, K121172, K092128, K090033, K073240, and K071438) and the Biomet Polaris Spinal System (K141804, K133746, K131615). The predicate devices and the subject addition to the PSS (Reform) system is designed for posterior stabilization to provide im…
Biomet Spine (Aka Ebi, LLC)2013—

Also cleared against K143248: 2 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K200303Reform Pedicle Screw SystemPrecision Spine202010
K193396PERLA® TL posterior osteosynthesis systemSpineart20207

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 14 years and passes through 8 companies; a new generation was cleared every 9 months on median.
  • 35 of the 368 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K200303 (Precision Spine, 2020) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K143248.

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. 2015, 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 (239 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; degenerative disc disease (DDD); 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K143248

2 other devices cite the same predicate.

  • K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017
  • 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/K151422 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151422: 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/K151422

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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