510(k) · Cleared
ClearedProficient™ Posterior Cervical Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · NKG Posterior Cervical Screw System
Cleared on Feb 7, 2017 as substantially equivalent to K142838 (Synthes USA Products, LLC, 2015) after a 138-day review. Its family tree reaches back 3 generations to 1997. 13 later devices descend from it.
- Decided
- Feb 7, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953076 (1997). 4 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 2 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 1 generation backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- This deviceK162639 Proficient™ Posterior Cervical Spine SystemSpine Wave, Inc. · 2017
- Descendant · cites it directly · 12 of its ownK172594 Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK182954 Salvo™ Spine SystemSpine Wave, Inc. · 2018
- Descendant · 3 generations on · 5 of its ownK191045 Salvo™ Spine SystemSpine Wave, Inc. · 2019
- Descendant · 4 generations on · 4 of its ownK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK181440 Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K172594Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2017 · cites it directly12descendants
- K182954Salvo™ Spine SystemSpine Wave, Inc. · 2018 · 2 generations on6descendants
- K191045Salvo™ Spine SystemSpine Wave, Inc. · 2019 · 3 generations on5descendants
- K202476Salvo® Spine SystemSpine Wave, Inc. · 2020 · 4 generations on4descendants
- K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −2 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −1 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| 0 (this device) | K162639 | Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| +1 | K172594 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| +2 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | — |
| +3 | K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019 | — |
| +4 | K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020 | — |
| +2 | K181440 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
Planning a device in NKG? 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? (1)
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 |
|---|---|---|---|
| * | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) SystemSummary page 4…d in this submission is substantially equivalent to the following predicates: Primary Predicate Device Manufacturer 510(k) No. Synapse™ OCT System DePuy Synthes, Inc. | K142838 Reference Predicate Devices Manufacturer 510(k) No. neon’ ™ Ulrich Medical K150650 Zero-P™ VA Synthes Spine, Inc. K112068 Mountai… | 2015 |
| † | K150650 | neon3 | 2015 |
| † | K112068 | Synthes Zero-P Variable Angle (VA) | 2011 |
| † | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | 2015 |
| † | K153631 | Zimmer Virage OCT Spinal Fixation System | 2016 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172594 | Proficient® Posterior Cervical Spine System | 2017 | 12 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K172594 (Spine Wave, Inc., 2017) has gone furthest, with 12 descendants of its own.
- 31 other devices also cite its predicate K142838.
How does its category compare?
All NKG devicesNKG Posterior Cervical 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 · 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 Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases…
Read the full statement (164 words)
The Proficient™ Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C2-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, 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 Proficient™ Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient™ Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient™ transition rods.
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/K162639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162639: Proficient™ Posterior Cervical Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162639
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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