510(k) · Cleared
ClearedQuantum/Streamline TL Mis Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Aug 10, 2010 as substantially equivalent to K080026 (Pioneer Surgical Technology, 2008) and 3 other predicates after a 245-day review. Its family tree reaches back 6 generations to 2000. 8 later devices descend from it.
- Decided
- Aug 10, 2010
- Review
- 245 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K992147 (2000). 18 ancestors in all, the oldest K000319 (2000). 8 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 5 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 4 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 3 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 2 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 1 generation backK080026 Quantum-Mis Cannulated SystemPioneer Surgical Technology · 2008
- This deviceK093771 Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010
- Descendant · cites it directly · 7 of its ownK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK140696 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014
- Descendant · 4 generations on · 3 of its ownK192800 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
- Descendant · 5 generations on · 2 of its ownK241892 Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · cites it directly7descendants
- K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013 · 2 generations on6descendants
- K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014 · 3 generations on5descendants
- K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020 · 4 generations on3descendants
- K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −5 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −4 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −3 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −2 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −1 | K080026 | Quantum-Mis Cannulated System | Pioneer Surgical Technology | 2008 | — |
| 0 (this device) | K093771 | Quantum/Streamline TL Mis Spinal System | Pioneer Surgical Technology | 2010 | — |
| +1 | K130286 | Streamline Mis Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2013 | 1 |
| +2 | K131100 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2013 | — |
| +3 | K140696 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2014 | — |
| +4 | K192800 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020 | — |
| +5 | K241892 | Cortera™ Spinal Fixation System | Xtant Medical Holdings, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K080026 | Quantum-Mis Cannulated SystemSummary page 1…Screw Spinal System - §888.3070, Class II. Product Codes: Product codes: MNH, MN!; Panel Code 87 Predicate Device: K080026 - Quantum MIS Cannulated System (SE date - 1/28/08) K072 187 - LowTop Spinal Rod System (SE date - 1… | 2008 |
| * | K072187 | Pioneer Lowtop Spinal Rod SystemSummary page 1…es: Product codes: MNH, MN!; Panel Code 87 Predicate Device: K080026 - Quantum MIS Cannulated System (SE date - 1/28/08) K072 187 - LowTop Spinal Rod System (SE date - 10/1 2/07) K0805 18 - Quantum Spinal System (SE date - 3/20/0… | 2007 |
| * | K080518 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…- Quantum MIS Cannulated System (SE date - 1/28/08) K072 187 - LowTop Spinal Rod System (SE date - 10/1 2/07) K0805 18 - Quantum Spinal System (SE date - 3/20/08) K080504 - LowTop Spinal Rod System (SE date - 3/20/08)… | 2008 |
| * | K080504 | Pioneer Lowtop Spinal Rod SystemSummary page 1…K072 187 - LowTop Spinal Rod System (SE date - 10/1 2/07) K0805 18 - Quantum Spinal System (SE date - 3/20/08) K080504 - LowTop Spinal Rod System (SE date - 3/20/08) Description: The Streamline MIS Cannulated System consists of rod… | 2008 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130286 | Streamline Mis Spinal Fixation System | 2013 | 7 |
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 10 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K130286 (Pioneer Surgical Technology, Inc., 2013) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K080026.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Streamline MIS Cannulated System is intended to provide imniobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis…
Read the full statement (126 words)
The Streamline MIS Cannulated System is intended to provide imniobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093771: Quantum/Streamline TL Mis Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093771
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