510(k) · Cleared
ClearedReform® Midline Cortical Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 19, 2017 as substantially equivalent to K150856 (Precision Spine, Inc., 2015) and 1 other predicate after an 81-day review. Its family tree reaches back 19 generations to 2001. 1 of the 428 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it.
- Decided
- Dec 19, 2017
- Review
- 81 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K003155 (2001). 406 ancestors in all, the oldest K781443 (1978). 21 later devices descend from it, 3 citing it directly. 1 of the 428 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations between
- 3 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 2 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 1 generation backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- This deviceK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
- Descendant · cites it directly · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- Descendant · cites it directly · 4 of its ownK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
- Descendant · 2 generations on · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
- Descendant · 2 generations on · 3 of its ownK232044 Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023
Show all 19 generations
- Root · 19 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 18 generations backK012254 VBROsteotech, Inc. · 2001
- 17 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 15 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 14 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 9 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 7 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 5 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 4 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 3 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 2 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 1 generation backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- This deviceK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
Most influential descendants
Showing 5 of 21 · See all- K220862E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022 · cites it directly7descendants
- K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · cites it directly7descendants
- K210539CoreLink Midline Fixation SystemCorelink, LLC · 2021 · cites it directly4descendants
- K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · 2 generations on4descendants
- K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −18 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −17 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −15 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −14 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −9 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −7 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −5 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −4 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −3 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −2 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| −1 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| 0 (this device) | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| +1 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | — |
| +1 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
| +1 | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | — |
| +2 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | — |
| +2 | K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 10 | 0 |
| 1996 | 10 | 0 |
| 1997 | 9 | 0 |
| 1998 | 19 | 0 |
| 1999 | 12 | 0 |
| 2000 | 26 | 0 |
| 2001 | 26 | 0 |
| 2002 | 24 | 0 |
| 2003 | 23 | 0 |
| 2004 | 36 | 0 |
| 2005 | 34 | 0 |
| 2006 | 25 | 0 |
| 2007 | 15 | 0 |
| 2008 | 26 | 0 |
| 2009 | 22 | 0 |
| 2010 | 21 | 1 |
| 2011 | 15 | 0 |
| 2012 | 10 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150856 | Reform Pedicle Screw SystemSummary page 6…l support mechanism K173130 - Page 2 of 2 Table 5-1: Predicate Devices 510k Trade or Proprietary or Model | Manufacturer Predicate Type Number | Name K150856 | Reform Pedicle Screw System Precision Spine Primary K171082 | JANUS Midline Orthofix Additional PERFORMANCE DATA The Reform®… | 2015 |
| * | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Summary page 6…e 5-1: Predicate Devices 510k Trade or Proprietary or Model | Manufacturer Predicate Type Number | Name K150856 | Reform Pedicle Screw System Precision Spine Primary K171082 | JANUS Midline Orthofix Additional PERFORMANCE DATA The Reform® Midline Cortical Screw System has been tested in the following… | 2017 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 41 of the 406 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220862 (Precision Spine, Inc., 2022) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K150856.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Reform® Midline Cortical Screw System is intended for posterior, non-cervical fixation
as an adjunct to fusion in skeletally mature patients for the following indications: degenerative
disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed
by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation);
spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis;
and/or failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173130: Reform® Midline Cortical 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/K173130
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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