510(k) · Cleared
ClearedReform® POCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · NKG Posterior Cervical Screw System
Cleared on Nov 22, 2016 as substantially equivalent to K152338 (Medtronic Sofamor Danek USA, Inc., 2015) and 3 other predicates after a 98-day review. Its family tree reaches back 14 generations to 1985. 1 of the 58 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 22, 2016
- Review
- 98 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K853033 (1985). 55 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 58 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 2 generations backK142741 OASYS SystemStryker Corporation · 2015
- 1 generation backK150851 Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
- This deviceK162300 Reform® POCT SystemPrecision Spine, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK172495 Reform® POCT SystemPrecision Spine, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK222107 Black Diamond™ POCT Spinal SystemOsseus Fusion Systems · 2022
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 5 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 4 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 3 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 2 generations backK142741 OASYS SystemStryker Corporation · 2015
- 1 generation backK150851 Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
- This deviceK162300 Reform® POCT SystemPrecision Spine, Inc. · 2016
Class I recalls in this family
- K093670 Modification to: Oasys System4 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −5 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −4 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −3 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −2 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −1 | K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | 2015 | — |
| 0 (this device) | K162300 | Reform® POCT System | Precision Spine, Inc. | 2016 | — |
| +1 | K172495 | Reform® POCT System | Precision Spine, Inc. | 2018 | — |
| +2 | K222107 | Black Diamond™ POCT Spinal System | Osseus Fusion Systems | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2008 | 4 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K152338 | VERTEX (r) Reconstruction SystemSummary page 6…. Table 5-1: Predicate Devices 510k Trade or Proprietary Manufacturer Type Number or Model Name K152338 VERTEX™ Medtronic Primary Reconstruction System K1… | 2015 |
| * | K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSummary page 6…Number or Model Name K152338 VERTEX™ Medtronic Primary Reconstruction System K150851 SureLOK Precision Additional K050979 S4 Spinal System Aesculap®, Inc. Additiona… | 2015 |
| * | K050979 | S4 Spinal SystemSummary page 6…Medtronic Primary Reconstruction System K150851 SureLOK Precision Additional K050979 S4 Spinal System Aesculap®, Inc. Additional K083071 VERTEX™ Medtronic Additiona… | 2005 |
| * | K083071 | Vertex Reconstruction SystemSummary page 6…Reconstruction System K150851 SureLOK Precision Additional K050979 S4 Spinal System Aesculap®, Inc. Additional K083071 VERTEX™ Medtronic Additional Reconstruction TECHNOLOGICAL CHARACTERISTICS The… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172495 | Reform® POCT System | 2018 | 1 |
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.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 55 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172495 (Precision Spine, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K152338.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and…
Read the full statement (142 words)
The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Precision Spine Reform® POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of 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/K162300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162300: Reform® POCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162300
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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