510(k) · Cleared
Recalled · Class II · 2013Streamline 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 Apr 1, 2013 as substantially equivalent to K111502 (Pioneer Surgical Technology, Inc., 2011) and 3 other predicates after a 55-day review. Its family tree reaches back 10 generations to 1990. 7 later devices descend from it. It has been recalled once.
- Decided
- Apr 1, 2013
- Review
- 55 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 10 generations to K901587 (1990). 75 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations between
- 3 generations backK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- 2 generations backK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- This deviceK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK140696 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK192800 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
- Descendant · 4 generations on · 2 of its ownK241892 Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024
- Descendant · 5 generations on · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
Show all 10 generations
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 9 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 8 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 7 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 6 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 5 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 4 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 3 generations backK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- 2 generations backK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- This deviceK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013 · cites it directly6descendants
- K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014 · 2 generations on5descendants
- K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020 · 3 generations on3descendants
- K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024 · 4 generations on2descendants
- K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −9 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −8 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −6 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −5 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −4 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −3 | K081331 | Fixxsure Cross Link | Spineworks, LLC | 2008 | — |
| −2 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −1 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| 0 (this device) | K130286 | Streamline Mis Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2013 | — |
| +1 | K131100 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2013 | — |
| +2 | K140696 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2014 | — |
| +3 | K192800 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020 | — |
| +4 | K241892 | Cortera™ Spinal Fixation System | Xtant Medical Holdings, Inc. | 2024 | — |
| +5 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K111502 | Streamline TL Spinal SystemSummary page 1…Classification: 888.3070 Pedicle Screw Spinal System; Class IllI Product Codes! NKB, MNH, MNI Panel: Panel Code 87 Predicates: KI 111502 Streamline TL Spinal System (SE 8-23-2011) K101790 Quantum Spinal System (SE 3-7-2011)… | 2011 |
| * | K101790 | Quantum Spinal System, Quantum MisSummary page 1…Product Codes! NKB, MNH, MNI Panel: Panel Code 87 Predicates: KI 111502 Streamline TL Spinal System (SE 8-23-2011) K101790 Quantum Spinal System (SE 3-7-2011) K093771 Streamline MIS Cannulated Screw System (SE 8-10-20 10)… | 2011 |
| * | K093771 | Quantum/Streamline TL Mis Spinal SystemSummary page 1…de 87 Predicates: KI 111502 Streamline TL Spinal System (SE 8-23-2011) K101790 Quantum Spinal System (SE 3-7-2011) K093771 Streamline MIS Cannulated Screw System (SE 8-10-20 10) K022949 Synthes USS (SE 3-24-2003) Description:… | 2010 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…K101790 Quantum Spinal System (SE 3-7-2011) K093771 Streamline MIS Cannulated Screw System (SE 8-10-20 10) K022949 Synthes USS (SE 3-24-2003) Description: The Streamline MIS Spinal Fixation System is a multiple component… | 2003 |
What descends from it? (7)
2 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 |
|---|---|---|---|---|
| Jun 14, 2013 | Class II | Z-2616-2014 | Device Design | The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 75 ancestors have a recall of any class.
- Of its descendants, K131100 (Pioneer Surgical Technology, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K111502.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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, T I-S2. Pedicle screw fixationis limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all of 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.…
Read the full statement (114 words)
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T I-S2. Pedicle screw fixationis limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all of 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.
The 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/K130286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130286: 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/K130286
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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