510(k) Report

510(k) · Cleared

Cleared

F1 MPS Modular Pedicle Screw System

K160926510(k) TraditionalCleared Jun 28, 201685-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

Degen Medical · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 28, 2016 as substantially equivalent to K142531 (Degen Medical, 2015) and 12 other predicates after an 85-day review. Its family tree reaches back 14 generations to 2004. 1 later device descends from it.

Decided
Jun 28, 2016
Review
85 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
13

Its longest line of descent runs back 14 generations to K040583 (2004). 96 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 3 other ancestors2006: 7 other ancestors2003: 7 other ancestors2001: 7 other ancestors1999: 2 other ancestors1998: 6 other ancestors1996: 5 other ancestors1994: 1 other ancestor2004: 17 other ancestors1997: 1 other ancestor1995: 3 other ancestors2011: 1 other ancestor2002: 5 other ancestors2000: 4 other ancestors2010: 1 other ancestor2009: 1 other ancestor2008: 2 other ancestors2005: 8 other ancestors1984: 1 other ancestor2018: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), 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) K130646 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K142531 · F1-Modular Pedicle Screw System · Degen Medical · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 9 other ancestors3 generations back: 2 other ancestors4 generations back: 9 other ancestors5 generations back: 12 other ancestors6 generations back: 15 other ancestors7 generations back: 13 other ancestors8 generations back: 10 other ancestors 1 generation forward: 1 descendant K142531 · F1-Modular Pedicle Screw System · Degen Medical · 2015K130646 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K113174 · 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 backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  5. 1 generation backK142531 F1-Modular Pedicle Screw SystemDegen Medical · 2015
  6. This deviceK160926 F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016
  7. Descendant · cites it directly · 0 of its ownK173814 DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical · 2018
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 backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  14. 1 generation backK142531 F1-Modular Pedicle Screw SystemDegen Medical · 2015
  15. This deviceK160926 F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical · 2018 · cites it directly0descendants
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
−2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−1K142531F1-Modular Pedicle Screw SystemDegen Medical2015—
0 (this device)K160926F1 MPS Modular Pedicle Screw SystemDegen Medical2016—
+1K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199410
199530
199650
199710
199860
199920
200040
200170
200250
200370
2004170
200580
200670
200730
200820
200910
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K160926, 2004–2018Source: 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? (13)

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
*K142531F1-Modular Pedicle Screw System
Summary page 5
…system Code – NKB 21 CFR 888.3070 : Class III Classification MNH, MNI, OSH 21 CFR 888.3070 : Class II Primary Predicate K142531 DeGen Medical F1 MPS Modular Pedicle Screw System Device Additional K061520, K071860 DePuy Spine Viper S…
Degen Medical2015—
*K061520Viper Spine System
Summary page 5
…1 CFR 888.3070 : Class II Primary Predicate K142531 DeGen Medical F1 MPS Modular Pedicle Screw System Device Additional K061520, K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector…
Depuy Spine, Inc.2006—
*K071860Modification to: Viper Spine System
Summary page 5
….3070 : Class II Primary Predicate K142531 DeGen Medical F1 MPS Modular Pedicle Screw System Device Additional K061520, K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K93…
Depuy Spine, Inc.2007—
*K062196SFX Snap-Fit Cross Connector
Summary page 5
…42531 DeGen Medical F1 MPS Modular Pedicle Screw System Device Additional K061520, K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K0…
Depuy Spine, Inc.2006—
*K933881Depuy Motech Moss-Miami Spinal System
Summary page 5
…ice Additional K061520, K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System ==…
Depuy, Inc.1994—
*K953915Moss Miami Spinal System (Anterior Use)
Summary page 5
…Additional K061520, K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System === Page 6…
Depuy, Inc.1996—
*K982320Depuy Motech Moss Miami Spinal System
Summary page 5
…ional K061520, K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System…
Depuy, Inc.1998—
*K982511Depuy Motech Moss Miami Spinal Systems
Summary page 5
…K061520, K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System…
Depuy, Inc.1998—
*K982011Depuy Motech Moss Miami Spinal System
Summary page 5
…K071860 DePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System…
DePuy Orthopaedics, Inc.1998—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 5
…ePuy Spine Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System…
Depuy, Inc.1998—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 5
…e Viper Spine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System…
Depuyacromed1999—
*K011182Modified Moss Miami 4.35MM Diameter Polyaxial Screws
Summary page 5
…pine System Predicates K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System…
Depuyacromed2001—
*K030383Modification to Moss Miami Spinal System Polyaxial Screws
Summary page 5
…K062196 DePuy Spine SFX Snap-Fit Cross Connector K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383 DePuy Moss Miami Spinal System…
Depuyacromed2003—

Also cleared against K142531: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180

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 12 years and passes through 4 companies; a new generation was cleared every 5 months on median.
  • 11 of the 96 ancestors have a recall of any class.
  • Of its descendants, K173814 (Degen Medical, 2018) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K142531.

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. 2016, 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 F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondylolisthesis…

Read the full statement (195 words)

The F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; Fracture; Dislocation; Spinal stenosis; Scoliosis or kyphotic deformities; Spinal Tumor; Schuermann’s disease; Failed previous fusion.

The F1 MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The F1 MPS is also intended to stabilize the posterior non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

Indications for use as stated in the FDA summary.

Also cleared against K142531

1 other device cites the same predicate.

  • K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical · 2018

More from Degen Medical

16 FDA decisions under this applicant name. See the company

  • K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2025
  • K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical · 2025
  • K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2025
  • K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical · 2024
  • K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023

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/K160926 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160926: F1 MPS Modular Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160926

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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