510(k) · Cleared
ClearedReform Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 19, 2020 as substantially equivalent to K150856 (Precision Spine, Inc., 2015) and 2 other predicates after a 103-day review. Its family tree reaches back 19 generations to 2001. 1 of the 409 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- May 19, 2020
- Review
- 103 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K003155 (2001). 398 ancestors in all, the oldest K781443 (1978). 10 later devices descend from it, 2 citing it directly. 1 of the 409 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 deviceK200303 Reform Pedicle Screw SystemPrecision Spine · 2020
- Descendant · cites it directly · 7 of its ownK220862 E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022
- Descendant · 2 generations on · 3 of its ownK232044 Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK240951 Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024
- Descendant · 4 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK242827 A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc. · 2025
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 deviceK200303 Reform Pedicle Screw SystemPrecision Spine · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 5 of 10 · See all- K220862E-GPS Navigated InstrumentsPrecision Spine, Inc. · 2022 · cites it directly7descendants
- K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc. · 2023 · 2 generations on3descendants
- K240951Invictus Robotic Navigation InstrumentsAlphatec Spine · 2024 · 3 generations on2descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 4 generations on1descendant
- K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc. · 2025 · cites it directly1descendant
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) | K200303 | Reform Pedicle Screw System | Precision Spine | 2020 | — |
| +1 | K220862 | E-GPS Navigated Instruments | Precision Spine, Inc. | 2022 | — |
| +2 | K232044 | Invictus Robotic Navigation Instruments | Alphatec Spine, Inc. | 2023 | — |
| +3 | K240951 | Invictus Robotic Navigation Instruments | Alphatec Spine | 2024 | — |
| +4 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +1 | K242827 | A8 INTEGR8™ Porous Pedicle Screws | Allumin8, Inc. | 2025 | — |
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 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 17 | 0 |
| 1999 | 12 | 0 |
| 2000 | 24 | 0 |
| 2001 | 28 | 0 |
| 2002 | 23 | 0 |
| 2003 | 23 | 0 |
| 2004 | 36 | 0 |
| 2005 | 34 | 0 |
| 2006 | 25 | 0 |
| 2007 | 17 | 0 |
| 2008 | 26 | 0 |
| 2009 | 24 | 0 |
| 2010 | 19 | 1 |
| 2011 | 15 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 4…on 888.3070 and 888.3050 Device Panel Orthopedic Primary Predicate Reform Polyaxial Pedicle Screw System - Precision Spine, Inc. (K150856) Device Secondary Predicate Reform HA Coated Pedicle Screw System – Precision Spine, Inc. (K151422) Devices… | 2015 |
| * | K151422 | Reform Pedicle Screw SystemSummary page 4…Reform Polyaxial Pedicle Screw System - Precision Spine, Inc. (K150856) Device Secondary Predicate Reform HA Coated Pedicle Screw System – Precision Spine, Inc. (K151422) Devices Firebird Spinal Fixation System – Orthofix, Inc. (K122901) The Reform System… | 2015 |
| * | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemSummary page 4…condary Predicate Reform HA Coated Pedicle Screw System – Precision Spine, Inc. (K151422) Devices Firebird Spinal Fixation System – Orthofix, Inc. (K122901) The Reform System is a top-loading, multiple component, posterior spinal fixation system… | 2012 |
What descends from it? (10)
2 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 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 38 of the 398 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. 2020, 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 Pedicle Screw System is intended for 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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture…
Read the full statement (185 words)
The Reform Pedicle Screw System is intended for 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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion. The Reform Pedicle Screw System is to be used with autograft and/or allograft.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Reform Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This 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.
https://510kreport.com/device/K200303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200303: Reform Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200303
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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