510(k) Report

510(k) · Cleared

Cleared

SurgTech Thoracolumbosacral (TLS) Posterior Fixation System

K163363510(k) TraditionalCleared Apr 5, 2017126-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

Surgtech, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 5, 2017 as substantially equivalent to K152457 (Medtronic Sofamor Danek USA, Inc., 2015) and 3 other predicates after a 126-day review. Its family tree reaches back 14 generations to 2004.

Decided
Apr 5, 2017
Review
126 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
4

Its longest line of descent runs back 14 generations to K040583 (2004). 86 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 2 other ancestors2005: 9 other ancestors2002: 6 other ancestors2014: 2 other ancestors2000: 5 other ancestors1999: 2 other ancestors1998: 3 other ancestors2011: 1 other ancestor2004: 15 other ancestors2003: 6 other ancestors1997: 1 other ancestor1996: 2 other ancestors1994: 1 other ancestor2010: 1 other ancestor2008: 2 other ancestors2006: 5 other ancestors2007: 2 other ancestors2001: 6 other ancestors1984: 1 other ancestor×3: 3 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004) ×4: 4 generations cleared close together, K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K142847 · CD HORIZON Spinal System · Medtronic Sofamor Danck USA, Inc. · 2014K152457 · CD HORIZON Spinal System · Medtronic Sofamor Danek USA, Inc. · 20151980199020002010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 8 other ancestors4 generations back: 18 other ancestors5 generations back: 16 other ancestors6 generations back: 13 other ancestors7 generations back: 10 other ancestors K152457 · CD HORIZON Spinal System · Medtronic Sofamor Danek USA, Inc. · 2015K142847 · CD HORIZON Spinal System · Medtronic Sofamor Danck USA, Inc. · 2014K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 10 generations between
  3. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  4. 2 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
  5. 1 generation backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
  6. This deviceK163363 SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc. · 2017
Show all 14 generations
  1. Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 2 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
  14. 1 generation backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
  15. This deviceK163363 SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−13K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−11K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−10K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−9K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−7K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−6K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−5K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−2K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014—
−1K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015—
0 (this device)K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199410
199620
199710
199830
199920
200050
200160
200260
200360
2004150
200590
200650
200720
200820
200920
201010
201110
201420
FIG. 1 — Lineage of K163363, 2004–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K152457CD HORIZON Spinal System
Summary page 4
…lloys (Ti-6Al-4V ELI per ASTM F136 and Ti-6Al-7Nb per ASTM F1295). Primary Predicate: CD Horizon® Spinal System (Medtronic Sofamor Danek – K152457) Additional Predicates: Matrix Spine System (Synthes Spine – K092929), Moss Miami™ Spinal System (DePu…
Medtronic Sofamor Danek USA, Inc.2015—
*K092929Synthes Matrix System
Summary page 4
…7Nb per ASTM F1295). Primary Predicate: CD Horizon® Spinal System (Medtronic Sofamor Danek – K152457) Additional Predicates: Matrix Spine System (Synthes Spine – K092929), Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623) and Optima™ Spinal System…
Synthes (Usa)20091
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 4
…ofamor Danek – K152457) Additional Predicates: Matrix Spine System (Synthes Spine – K092929), Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623) and Optima™ Spinal System (U&I Corporation – K051971) Performance Data: Mechanical testing of wo…
Depuyacromed2002—
*K051971Optima Spinal System
Summary page 4
…pine – K092929), Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623) and Optima™ Spinal System (U&I Corporation – K051971) Performance Data: Mechanical testing of worst case SurgTech TLS System constructs included stati…
U&I Corp.2005—

Also cleared against K152457: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 5 companies; a new generation was cleared every 5 months on median.
  • 12 of the 86 ancestors have a recall of any class.
  • 7 other devices also cite its predicate K152457.

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. 2017, 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 SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K152457

7 other devices cite the same predicate.

  • K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd. · 2024
  • K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC · 2022
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
  • K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
  • K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION…Medtronic Sofamor Danek USA, Inc. · 2016

More from Surgtech, Inc.

6 FDA decisions under this applicant name. See the company

  • K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc. · 2019
  • K173455SurgTech Bipolar Head SystemSurgtech, Inc. · 2018
  • K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017
  • K152200SurgTech Interbody SystemSurgtech, Inc. · 2016

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/K163363 · printed Nov 4, 2026

Cite this page

510(k) Report. “K163363: SurgTech Thoracolumbosacral (TLS) Posterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163363

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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