510(k) · Cleared
Recalled · Class II · 2018Lineum OCT Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · NKG Posterior Cervical Screw System
Cleared on Jun 30, 2015 as substantially equivalent to K142838 (Synthes USA Products, LLC, 2015) after a 54-day review. Its family tree reaches back 3 generations to 1997. 23 later devices descend from it. It has been recalled once.
- Decided
- Jun 30, 2015
- Review
- 54 days
- Class
- Class II
- Product code
- NKG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953076 (1997). 4 ancestors in all. 23 later devices descend from it, 2 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 deviceK151224 Lineum OCT Spine SystemBiomet Spine · 2015
- Descendant · cites it directly · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- 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 · 2 generations on · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · cites it directly13descendants
- 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
- K182182YUKON OCT Spinal SystemK2m · 2018 · 2 generations on5descendants
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) | K151224 | Lineum OCT Spine System | Biomet Spine | 2015 | — |
| +1 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| +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 | — |
| +2 | K182182 | YUKON OCT Spinal System | K2m | 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 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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…Class 2 per 21 CFR 888.3050 Product Code: KWP Primary Predicate: Synapse Occipital-Cervical-Thoracic (OCT) System – K142838 Reference Devices: Integra Atoll – K083073 Nextgen Altius OCT System – K113593… | 2015 |
| † | K083073 | Theken Atoll Cervico-Thoracic System | 2009 |
| † | K113593 | Nextgen Altius Oct System | 2012 |
| † | K080828 | Mountaineer Oct Spinal System | 2008 |
What descends from it? (23)
See all 232 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2018 | Class II | Z-1735-2019 | Process control | Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 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, K171444 (K2m, Inc., 2017) has gone furthest, with 13 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. 2015, 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 Lineum OCT Spine 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 (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic spine; and…
Read the full statement (191 words)
The Lineum OCT Spine 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 (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical/thoracic 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 Lineum OCT Spine 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.
In order to achieve additional levels of fixation, the Lineum OCT Spine System can also be connected to the Biomet Polaris System via transitional rods or using the Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system’s package insert for a list of indications for use for each system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151224: Lineum OCT 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/K151224
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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