510(k) · Cleared
ClearedStreamline MIS Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 26, 2019 as substantially equivalent to K130286 (Pioneer Surgical Technology, Inc., 2013) and 1 other predicate after an 84-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Nov 26, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K901587 (1990). 144 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 9 generations between
- 3 generations backK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · Recalled
- 2 generations backK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
- 1 generation backK140696 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014
- This deviceK192396 Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2019
Show all 13 generations
- Root · 13 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 12 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 11 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 10 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 9 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 8 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 7 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 6 generations backK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- 5 generations backK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 4 generations backK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 3 generations backK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · Recalled
- 2 generations backK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
- 1 generation backK140696 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014
- This deviceK192396 Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −12 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −11 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −10 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −9 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −8 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −7 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −6 | K081331 | Fixxsure Cross Link | Spineworks, LLC | 2008 | — |
| −5 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −4 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −3 | K130286 | Streamline Mis Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2013 | 1 |
| −2 | K131100 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2013 | — |
| −1 | K140696 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2014 | — |
| 0 (this device) | K192396 | Streamline MIS Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 12 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K130286 | Streamline Mis Spinal Fixation SystemSummary page 4…oracolumbosacral pedicle screw system Product Codes: NKB (thoracolumbosacral pedicle screw system) Product Classification: Class II Predicate Device K130286 Streamline MIS Spinal Fixation System Additional Predicate Device K140696 Streamline TL Spinal Fixation System Device Descripti… | 2013 |
| * | K140696 | Streamline TL Spinal Fixation SystemSummary page 4…racolumbosacral pedicle screw system) Product Classification: Class II Predicate Device K130286 Streamline MIS Spinal Fixation System Additional Predicate Device K140696 Streamline TL Spinal Fixation System Device Description Streamline MIS Spinal Fixation System is a temporary, multiple componen… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 144 ancestors have a recall of any class.
- 1 other device also cites its predicate K130286.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)…
Read the full statement (116 words)
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192396: Streamline MIS Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192396
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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