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 Jul 30, 2018 as substantially equivalent to K172594 (Spine Wave, Inc., 2017) after a 59-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.
- Decided
- Jul 30, 2018
- Review
- 59 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953076 (1997). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 4 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 3 generations backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- 2 generations backK151224 Lineum OCT Spine SystemBiomet Spine · 2015 · Recalled
- 1 generation backK172594 Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2017
- This deviceK181440 Proficient® Posterior Cervical Spine SystemSpine Wave, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK203125 Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · cites it directly3descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 2 generations on1descendant
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 3 generations on0descendants
- K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −4 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −3 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| −2 | K151224 | Lineum OCT Spine System | Biomet Spine | 2015 | 1 |
| −1 | K172594 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| 0 (this device) | K181440 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | 2018 | — |
| +1 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +2 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +3 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
| +2 | K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K172594 | Proficient® Posterior Cervical Spine SystemSummary page 4…dicate Device Manufacturer 510(k) No. ® Proficient Posterior Cervical Spine System Spine Wave, Inc. K172594 5. Device Description The modified Proficient® Posterior Cervical Spine System consists of a selection of non-steri… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200936 | Invictus™ CT Spinal Fixation System | 2020 | 3 |
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 21 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K200936 (Alphatec Spine, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K172594.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 (164 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181440: 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/K181440
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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