510(k) · Cleared
ClearedQuantum-Mis Cannulated System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jan 28, 2008 as substantially equivalent to K041167 (Pioneer Surgical Technology, 2004) and 2 other predicates after a 24-day review. Its family tree reaches back 5 generations to 2000. 12 later devices descend from it.
- Decided
- Jan 28, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K992147 (2000). 15 ancestors in all, the oldest K000319 (2000). 12 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 4 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 3 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 2 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 1 generation backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- This deviceK080026 Quantum-Mis Cannulated SystemPioneer Surgical Technology · 2008
- Descendant · cites it directly · 10 of its ownK101790 Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
- Descendant · cites it directly · 8 of its ownK093771 Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010
- Descendant · 2 generations on · 7 of its ownK130286 Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 6 of its ownK131100 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013
- Descendant · 4 generations on · 5 of its ownK140696 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011 · cites it directly10descendants
- K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010 · cites it directly8descendants
- K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2013 · 2 generations on7descendants
- K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2013 · 3 generations on6descendants
- K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. · 2014 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −4 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −3 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −2 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −1 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| 0 (this device) | K080026 | Quantum-Mis Cannulated System | Pioneer Surgical Technology | 2008 | — |
| +1 | K101790 | Quantum Spinal System, Quantum Mis | Pioneer Surgical Technology | 2011 | — |
| +1 | K093771 | Quantum/Streamline TL Mis Spinal System | Pioneer Surgical Technology | 2010 | — |
| +2 | K130286 | Streamline Mis Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2013 | 1 |
| +3 | K131100 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2013 | — |
| +4 | K140696 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 MNI? 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? (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 |
|---|---|---|---|
| * | K041167 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…deral Regulations, Title 21, Section 888.3070: Pedicle Screw Spinal System. The product codes are MNH, and MNI. The Panel code is 87. Predicate K041167 - Quantum Spinal System Device: K070551 - Quantum Spinal System K072187 - LowTop Spinal Rod System I… | 2004 |
| * | K070551 | Modification to: Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…dicle Screw Spinal System. The product codes are MNH, and MNI. The Panel code is 87. Predicate K041167 - Quantum Spinal System Device: K070551 - Quantum Spinal System K072187 - LowTop Spinal Rod System Intended The Quantum - MIS Cannulated System… | 2007 |
| * | K072187 | Pioneer Lowtop Spinal Rod SystemSummary page 1…roduct codes are MNH, and MNI. The Panel code is 87. Predicate K041167 - Quantum Spinal System Device: K070551 - Quantum Spinal System K072187 - LowTop Spinal Rod System Intended The Quantum - MIS Cannulated System is intended to provide Use: immobili… | 2007 |
What descends from it? (12)
See all 122 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)
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 8 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K101790 (Pioneer Surgical Technology, 2011) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K041167.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantum - MIS Cannulated System is intended to provide immobilization 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…
Read the full statement (127 words)
The Quantum - MIS Cannulated System is intended to provide immobilization 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 L5-S1 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/K080026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080026: Quantum-Mis Cannulated System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080026
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