510(k) · Cleared
ClearedQuantum Spinal System, Quantum Mis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 7, 2011 as substantially equivalent to K080518 (Pioneer Surgical Technology, 2008) and 6 other predicates after a 252-day review. Its family tree reaches back 7 generations to 2004. 10 later devices descend from it.
- Decided
- Mar 7, 2011
- Review
- 252 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K040583 (2004). 46 ancestors in all, the oldest K980288 (1998). 10 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 4 generations backK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK072317 Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · Recalled
- 2 generations backK081080 TSRH Spinal SystemMedtronic Sofamor Danek · 2008
- 1 generation backK091797 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK101790 Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
- 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 · cites it directly · 3 of its ownK192800 Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
- Descendant · 2 generations on · 2 of its ownK241892 Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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 · cites it directly3descendants
- K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −4 | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K072317 | Modification to:TSRH Spinal System | Medtronic Sofamor Danek USA, Inc. | 2007 | 4 |
| −2 | K081080 | TSRH Spinal System | Medtronic Sofamor Danek | 2008 | — |
| −1 | K091797 | TSRH Spinal System | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K101790 | Quantum Spinal System, Quantum Mis | Pioneer Surgical Technology | 2011 | — |
| +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 | — |
| +1 | K192800 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020 | — |
| +2 | K241892 | Cortera™ Spinal Fixation System | Xtant Medical Holdings, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 7 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (7)
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 |
|---|---|---|---|
| * | K080518 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…nal System, Product codes MNH, MNI Class 11, NKB Class Ill. Predicate Devices: Quantum (including MIS) Spinal Implant System Pedicle Screws (K0805 18, K080026, K070973, K070551 and K041 167); Dynesys hydroxyapatite-coated screws (K… | 2008 |
| * | K080026 | Quantum-Mis Cannulated SystemSummary page 1…, Product codes MNH, MNI Class 11, NKB Class Ill. Predicate Devices: Quantum (including MIS) Spinal Implant System Pedicle Screws (K0805 18, K080026, K070973, K070551 and K041 167); Dynesys hydroxyapatite-coated screws (K060638);… | 2008 |
| * | K070973 | Quantum Spinal SystemSummary page 1…Class 11, NKB Class Ill. Predicate Devices: Quantum (including MIS) Spinal Implant System Pedicle Screws (K0805 18, K080026, K070973, K070551 and K041 167); Dynesys hydroxyapatite-coated screws (K060638); and TSRH hydrox… | 2007 |
| * | K070551 | Modification to: Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…Class 11, NKB Class Ill. Predicate Devices: Quantum (including MIS) Spinal Implant System Pedicle Screws (K0805 18, K080026, K070973, K070551 and K041 167); Dynesys hydroxyapatite-coated screws (K060638); and TSRH hydroxyapatite-… | 2007 |
| * | K041167 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…11, NKB Class Ill. Predicate Devices: Quantum (including MIS) Spinal Implant System Pedicle Screws (K0805 18, K080026, K070973, K070551 and K041 167); Dynesys hydroxyapatite-coated screws (K060638); and TSRH hydroxyapatite-coated screws… | 2004 |
| * | K060638 | Dynesys Spinal System with HA Coated ScrewsSummary page 1…l Implant System Pedicle Screws (K0805 18, K080026, K070973, K070551 and K041 167); Dynesys hydroxyapatite-coated screws (K060638); and TSRH hydroxyapatite-coated screws (K091797). Description: The Quantum Spinal System (includin… | 2006 |
| * | K091797 | TSRH Spinal SystemSummary page 1…K070973, K070551 and K041 167); Dynesys hydroxyapatite-coated screws (K060638); and TSRH hydroxyapatite-coated screws (K091797). Description: The Quantum Spinal System (including MIS) consists of a variety of rods, fixed and p… | 2010 |
What descends from it? (10)
3 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 7 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 9 of the 46 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.
- 7 other devices also cite its predicate K080518.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Quantum-MIS Cannulated System is intended to provide immobilization and stabilization of spinal segments iii 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 spondlylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and…
Read the full statement (234 words)
The Quantum-MIS Cannulated System is intended to provide immobilization and stabilization of spinal segments iii 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 spondlylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal turnor, and failed previous fusion (pseudoarthirosis). In additioii, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L-3-S 1) with removal of the implants after the -attainment of a solid fusion.
The Quantum Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw system (TI - S2), posterior hook (TI-L5) sacral/iliac screw fixatioii or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lqrdosis, Scheuermann's Disease), tumnor, stenosis, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101790: Quantum Spinal System, Quantum Mis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101790
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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