510(k) · Cleared
ClearedStreamline OCT Occipito-Cervico-Thoracic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · NKG Posterior Cervical Screw System
Cleared on Aug 22, 2016 as substantially equivalent to K143471 (Medtronic Sofamor Danek USA, Inc., 2015) and 2 other predicates after an 82-day review. Its family tree reaches back 17 generations to 2001. 1 later device descends from it.
- Decided
- Aug 22, 2016
- Review
- 82 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K003155 (2001). 129 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- 2 generations backK133374 Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
- 1 generation backK150254 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · Recalled
- This deviceK161498 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016
- Descendant · cites it directly · 0 of its ownK172139 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2017
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 7 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 5 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 3 generations backK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- 2 generations backK133374 Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
- 1 generation backK150254 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · Recalled
- This deviceK161498 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016
Most influential descendants
Showing 1 of 1 · See all- K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −7 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −5 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −3 | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | Pioneer Surgical Technology, Inc. | 2012 | — |
| −2 | K133374 | Streamline Oct Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014 | — |
| −1 | K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015 | 3 |
| 0 (this device) | K161498 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016 | — |
| +1 | K172139 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 22 | 0 |
| 2005 | 11 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
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 |
|---|---|---|---|
| * | K143471 | VERTEX Reconstruction SystemSummary page 4…; Pre-amendment device (Product Code NKG, KWP) Panel: Panel Code 87 Primary Predicate: Medtronic VERTEX Reconstruction System (K143471) Additional Streamline OCT Spinal System (K150254) Predicates: DePuy Mountaineer OCT Spinal System (K15188… | 2015 |
| * | K150254 | Streamline OCT Occipito-Cervico-Thoracic SystemSummary page 4…G, KWP) Panel: Panel Code 87 Primary Predicate: Medtronic VERTEX Reconstruction System (K143471) Additional Streamline OCT Spinal System (K150254) Predicates: DePuy Mountaineer OCT Spinal System (K151885) Description: The Streamline OCT System consists o… | 2015 |
| * | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemSummary page 4…edtronic VERTEX Reconstruction System (K143471) Additional Streamline OCT Spinal System (K150254) Predicates: DePuy Mountaineer OCT Spinal System (K151885) Description: The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws,… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172139 | Streamline OCT Occipito-Cervico-Thoracic System | 2017 | 0 |
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 15 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 13 of the 129 ancestors have a recall of any class.
- Of its descendants, K172139 (Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), 2017) has gone furthest, with 0 descendants of its own.
- 18 other devices also cite its predicate K143471.
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 Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion when using autograft and/or allograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g.…
Read the full statement (179 words)
The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion when using autograft and/or allograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to 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 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 Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161498: Streamline OCT Occipito-Cervico-Thoracic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161498
Report an extraction error
Are you the manufacturer?
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