510(k) Report

510(k) · Cleared

Cleared

Modification to: Pioneer Surgical Technology Quantum Spinal System

K070551510(k) SpecialCleared Mar 29, 200730-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pioneer Surgical Technology · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 29, 2007 as substantially equivalent to K041167 (Pioneer Surgical Technology, 2004) after a 30-day review. Its family tree reaches back 1 generation to 2004. 193 later devices descend from it.

Decided
Mar 29, 2007
Review
30 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K041167 (2004). 193 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2008: 5 descendants cleared2011: 5 descendants cleared2009: 2 descendants cleared2012: 2 descendants cleared2010: 4 descendants cleared2014: 4 descendants cleared2013: 7 descendants cleared2020: 9 descendants cleared2016: 7 descendants cleared2022: 16 descendants cleared2015: 9 descendants cleared2019: 6 descendants cleared2024: 19 descendants cleared2021: 10 descendants cleared2023: 18 descendants cleared2025: 24 descendants cleared2026: 25 descendants cleared2017: 10 descendants cleared2018: 9 descendants clearedK041167 · Pioneer Surgical Technology Quantum Spinal System · Pioneer Surgical Technology · 2004 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 11 descendants3 generations forward: 12 descendants4 generations forward: 11 descendants5 generations forward: 9 descendants6 generations forward: 16 descendants7 generations forward: 18 descendants8 generations forward: 31 descendants9 generations forward: 23 descendants10 generations forward: 13 descendants11 generations forward: 13 descendants12 generations forward: 16 descendants13 generations forward: 14 descendants14 generations forward: 1 descendant K041167 · Pioneer Surgical Technology Quantum Spinal System · Pioneer Surgical Technology · 2004 · recalled0+5+10
  1. Root · 1 generation backK041167 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2004 · Recalled
  2. This deviceK070551 Modification to: Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2007
  3. Descendant · cites it directly · 178 of its ownK070973 Quantum Spinal SystemPioneer Surgical Technology · 2007
  4. Descendant · 2 generations on · 177 of its ownK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
  5. Descendant · 2 generations on · 174 of its ownK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
  6. Descendant · 3 generations on · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
  7. Descendant · 4 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled

Showing 5 of 193 descendants. See all descendants

Descendants cleared per year

2007: 22008: 52009: 22010: 42011: 52012: 22013: 72014: 42015: 92016: 72017: 102018: 92019: 62020: 92021: 102022: 162023: 182024: 192025: 242026: 25
2007high 25 (2026) · low 2 (2007)2026

Most influential descendants

Showing 5 of 193 · See all
  • K070973Quantum Spinal SystemPioneer Surgical Technology · 2007 · cites it directly178descendants
  • K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007 · 2 generations on177descendants
  • K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008 · 2 generations on174descendants
  • K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · 3 generations on136descendants
  • K110497Pass LP Spinal SystemMedicrea International · 2011 · 4 generations on133descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K041167Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology20041
0 (this device)K070551Modification to: Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2007—
+1K070973Quantum Spinal SystemPioneer Surgical Technology2007—
+2K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology2007—
+2K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology2008—
+3K100297Pass LP Spinal SystemMedicrea Technologies2010—
+4K110497Pass LP Spinal SystemMedicrea International20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200850
200920
201040
201150
201220
201370
201440
201590
201670
2017100
201890
201960
202090
2021100
2022160
2023180
2024190
2025240
2026250
FIG. 1 — Lineage of K070551, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K041167Pioneer Surgical Technology Quantum Spinal System
Summary page 1
…, Spondylolisthesis Spinal Fixation Device System and Pedicle Screw Spinal System, Class III. Predicate Device: K041167 - Quantum Spinal System (SE date - July 23, 2004) Intended Use: The Quantum Spinal System components are…
Pioneer Surgical Technology20041

Also cleared against K041167: 5 other devices →

What descends from it? (193)

See all 193

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070973Quantum Spinal SystemPioneer Surgical Technology2007178
K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology200892
K091266Theken Coral Spinal SystemTheken Spine, LLC200915
K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology200812
K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110

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?

  • Its one ancestor has a recall.
  • Of its descendants, K070973 (Pioneer Surgical Technology, 2007) has gone furthest, with 178 descendants of its own.
  • 5 other devices also cite its predicate K041167.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (Ti - S2) 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…

Read the full statement (97 words)

The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (Ti - S2) 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 lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K041167

5 other devices cite the same predicate.

  • K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
  • K090222Pioneer Lumbar Plate SystemPioneer Surgical Technology · 2009
  • K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2008
  • K080026Quantum-Mis Cannulated SystemPioneer Surgical Technology · 2008
  • K070973Quantum Spinal SystemPioneer Surgical Technology · 2007

More from Pioneer Surgical Technology

50 FDA decisions under this applicant name. See the company

  • K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011
  • K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
  • K101525Pioneer Spinous Process Fusion PlatePioneer Surgical Technology · 2010
  • K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010
  • K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K070551 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070551: Modification to: Pioneer Surgical Technology Quantum 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/K070551

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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