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 Dec 15, 2017 as substantially equivalent to K162639 (Spine Wave, Inc., 2017) and 2 other predicates after a 108-day review. Its family tree reaches back 4 generations to 1997. 12 later devices descend from it.
- Decided
- Dec 15, 2017
- Review
- 108 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953076 (1997). 6 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 3 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 2 generations backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- 1 generation backK151224 Lineum OCT Spine SystemBiomet Spine · 2015 · Recalled
- This deviceK172594 Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK182954 Salvo™ Spine SystemSpine Wave, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK191045 Salvo™ Spine SystemSpine Wave, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK181440 Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK222362 Salvo® Spine SystemSpine Wave, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K182954Salvo™ Spine SystemSpine Wave, Inc. · 2018 · cites it directly6descendants
- K191045Salvo™ Spine SystemSpine Wave, Inc. · 2019 · 2 generations on5descendants
- K202476Salvo® Spine SystemSpine Wave, Inc. · 2020 · 3 generations on4descendants
- K181440Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2018 · cites it directly4descendants
- K222362Salvo® Spine SystemSpine Wave, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −3 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −2 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| −1 | K151224 | Lineum OCT Spine System | Biomet Spine | 2015 | 1 |
| 0 (this device) | K172594 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| +1 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | — |
| +2 | K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019 | — |
| +3 | K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020 | — |
| +1 | K181440 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2018 | — |
| +4 | K222362 | Salvo® Spine System | Spine Wave, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K162639 | Proficient™ Posterior Cervical Spine SystemSummary page 4…Primary Predicate Device Manufacturer 510(k) No. Proficient® Posterior Cervical Spine System Spine Wave, Inc. K162639 Additional Predicate Devices Manufacturer 510(k) No. Lineum OCT Spine System… | 2017 |
| * | K151224 | Lineum OCT Spine SystemSummary page 4…Additional Predicate Devices Manufacturer 510(k) No. Lineum OCT Spine System Biomet K151224 Synapse OCT System Synthes K142838… | 2015 |
| * | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) SystemSummary page 4…Lineum OCT Spine System Biomet K151224 Synapse OCT System Synthes K142838 K172594… | 2015 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K182954 (Spine Wave, Inc., 2018) has gone furthest, with 6 descendants of its own.
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 (C1-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 (165 words)
The Proficient® Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C1-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 as stated in the FDA summary.
https://510kreport.com/device/K172594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172594: 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/K172594
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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