510(k) · Cleared
ClearedStreamline TL Spinal 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 Jun 27, 2013 as substantially equivalent to K111502 (Pioneer Surgical Technology, Inc., 2011) and 2 other predicates after a 69-day review. Its family tree reaches back 11 generations to 1990. 6 later devices descend from it.
- Decided
- Jun 27, 2013
- Review
- 69 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K901587 (1990). 76 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 7 generations between
- 3 generations backK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 2 generations backK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · Recalled
- This deviceK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK140696 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK192800 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
- Descendant · 3 generations on · 2 of its ownK241892 Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024
- Descendant · 4 generations on · 1 of its ownK243946 EffortMed Spinal Fixation SystemEffortmed, LLC · 2025
- Descendant · 5 generations on · 0 of its ownK254247 Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 10 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 9 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 8 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 7 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 6 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 5 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 4 generations backK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- 3 generations backK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 2 generations backK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- 1 generation backK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · Recalled
- This deviceK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014 · cites it directly5descendants
- K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020 · 2 generations on3descendants
- K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024 · 3 generations on2descendants
- K243946EffortMed Spinal Fixation SystemEffortmed, LLC · 2025 · 4 generations on1descendant
- K254247Osteomni Spinal Fixation SystemOsteomni, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −10 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −9 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −8 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −6 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −5 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −4 | K081331 | Fixxsure Cross Link | Spineworks, LLC | 2008 | — |
| −3 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −2 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| −1 | K130286 | Streamline Mis Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2013 | 1 |
| 0 (this device) | K131100 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2013 | — |
| +1 | K140696 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2014 | — |
| +2 | K192800 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020 | — |
| +3 | K241892 | Cortera™ Spinal Fixation System | Xtant Medical Holdings, Inc. | 2024 | — |
| +4 | K243946 | EffortMed Spinal Fixation System | Effortmed, LLC | 2025 | — |
| +5 | K254247 | Osteomni Spinal Fixation System | Osteomni, Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K111502 | Streamline TL Spinal SystemSummary page 1…System 21 CFR 888.3060, Spondylolisthesis Spinal Fixation Device System and 21 CFR ' 888.3070 Pedicle Screw Spinal System, Class [11 NKB, KWQ, MNI, MNH Panel Code 87 K 111502 Streamline TL Spinal System (SE 8-23-2011) - K 130286 Streamline MIS Spinal Fixation System (SE 4-1-2013) K 022949 Synthes USS (S… | 2011 |
| * | K130286 | Streamline Mis Spinal Fixation SystemSummary page 1…ation Device System and 21 CFR ' 888.3070 Pedicle Screw Spinal System, Class [11 NKB, KWQ, MNI, MNH Panel Code 87 K 111502 Streamline TL Spinal System (SE 8-23-2011) - K 130286 Streamline MIS Spinal Fixation System (SE 4-1-2013) K 022949 Synthes USS (SE 3-24-2003) The Streamline TL Spinal System consists… | 2013 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…l System, Class [11 NKB, KWQ, MNI, MNH Panel Code 87 K 111502 Streamline TL Spinal System (SE 8-23-2011) - K 130286 Streamline MIS Spinal Fixation System (SE 4-1-2013) K 022949 Synthes USS (SE 3-24-2003) The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reducti… | 2003 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140696 | Streamline TL Spinal Fixation System | 2014 | 5 |
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 23 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 76 ancestors have a recall of any class.
- Of its descendants, K140696 (Pioneer Surgical Technology, Inc., 2014) has gone furthest, with 5 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 TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8 — L35). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc…
Read the full statement (97 words)
The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8 — L35). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studics), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
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/K131100 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131100: Streamline TL Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131100
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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