510(k) Report

510(k) · Cleared

Cleared

Securis Spinal Fixation

K113361510(k) TraditionalCleared Apr 3, 2012141-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

Cumtom Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 3, 2012 as substantially equivalent to K933881 (Depuy, Inc., 1994) and 10 other predicates after a 141-day review. Its family tree reaches back 6 generations to 1999.

Decided
Apr 3, 2012
Review
141 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
11

Its longest line of descent runs back 6 generations to K990745 (1999). 34 ancestors in all, the oldest K926453 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2007: 2 other ancestors2005: 2 other ancestors2003: 3 other ancestors2002: 2 other ancestors1998: 1 other ancestor1997: 3 other ancestors1996: 1 other ancestor1994: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2000: 5 other ancestors1999: 1 other ancestor2001: 2 other ancestors1995: 1 other ancestor1993: 1 other ancestorK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999K992739 · Click'x · Synthes Spine · 2000 · recalledK052123 · Synthes Pangea System · Synthes (Usa) · 2005K082914 · Clampfix · Synthes Spine · 2008K090605 · Clampfix · Synthes (Usa) · 2009K103287 · Synthes 6.0 Cocr and CPT TI-3 Rods · Synthes Spine · 201119901995200020052010
Other ancestors, by generation 1 generation back: 10 other ancestors2 generations back: 10 other ancestors3 generations back: 8 other ancestors K103287 · Synthes 6.0 Cocr and CPT TI-3 Rods · Synthes Spine · 2011K090605 · Clampfix · Synthes (Usa) · 2009K082914 · Clampfix · Synthes Spine · 2008K052123 · Synthes Pangea System · Synthes (Usa) · 2005K992739 · Click'x · Synthes Spine · 2000 · recalledK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999−50
  1. Root · 6 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 5 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
  3. 4 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
  4. 3 generations backK082914 ClampfixSynthes Spine · 2008
  5. 2 generations backK090605 ClampfixSynthes (Usa) · 2009
  6. 1 generation backK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
  7. This deviceK113361 Securis Spinal FixationCumtom Spine · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K990745Modification to Synthes Universal Spinal SystemSynthes Spine1999—
−5K992739Click'xSynthes Spine20001
−4K052123Synthes Pangea SystemSynthes (Usa)2005—
−3K082914ClampfixSynthes Spine2008—
−2K090605ClampfixSynthes (Usa)2009—
−1K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine2011—
0 (this device)K113361Securis Spinal FixationCumtom Spine2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510
199610
199730
199810
199910
200050
200120
200220
200330
200520
200720
200810
200910
201110
FIG. 1 — Lineage of K113361, 1999–2012Source: 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? (11)

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
*K933881Depuy Motech Moss-Miami Spinal System
Summary page 1
…Classification: Class III Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, MNI, MNH Predicate Devices Moss® Miami Spinal System (K(933881, K955348, K964024, K(983583, K(02 2623), Optima® Spinal System (K(031585), Synthes; Pangea System (1(103287), Custom Spine…
Depuy, Inc.1994—
*K955348Titanium Moss Miami Spinal System
Summary page 1
…ication: Class III Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, MNI, MNH Predicate Devices Moss® Miami Spinal System (K(933881, K955348, K964024, K(983583, K(02 2623), Optima® Spinal System (K(031585), Synthes; Pangea System (1(103287), Custom Spine ISS…
Depuy, Inc.1996—
*K964024Depuy Motech Titanium Moss Miami Spinal System
Summary page 1
…Class III Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, MNI, MNH Predicate Devices Moss® Miami Spinal System (K(933881, K955348, K964024, K(983583, K(02 2623), Optima® Spinal System (K(031585), Synthes; Pangea System (1(103287), Custom Spine ISSYS LP (K(…
Depuy, Inc.1997—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, MNI, MNH Predicate Devices Moss® Miami Spinal System (K(933881, K955348, K964024, K(983583, K(02 2623), Optima® Spinal System (K(031585), Synthes; Pangea System (1(103287), Custom Spine ISSYS LP (K(070821, K…
Depuy, Inc.1998—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002—
*K031585U&I, Optima, Spinal System
Summary page 1
…e Product Codes: NKB, MNI, MNH Predicate Devices Moss® Miami Spinal System (K(933881, K955348, K964024, K(983583, K(02 2623), Optima® Spinal System (K(031585), Synthes; Pangea System (1(103287), Custom Spine ISSYS LP (K(070821, K 072866, K(110099), ISSYS (043522). Device Des…
U&I Corp., America20035
*K103287Synthes 6.0 Cocr and CPT TI-3 Rods
Summary page 1
…Predicate Devices Moss® Miami Spinal System (K(933881, K955348, K964024, K(983583, K(02 2623), Optima® Spinal System (K(031585), Synthes; Pangea System (1(103287), Custom Spine ISSYS LP (K(070821, K 072866, K(110099), ISSYS (043522). Device Description The subject Securis…
Synthes Spine2011—
*K070281Issys LP Spinal Fixation System
Our reading of the summary gave K070821, FDA’s number for Powdered Natural Rubber Latex Examination Gloves (Protein… (Medtexx Manufacturing Sdn. Bhd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ISSYS LP”.
Custom Spine, Inc.20071
*K072866Issys LP Spinal Fixation System
Summary page 1
…stem (K(933881, K955348, K964024, K(983583, K(02 2623), Optima® Spinal System (K(031585), Synthes; Pangea System (1(103287), Custom Spine ISSYS LP (K(070821, K 072866, K(110099), ISSYS (043522). Device Description The subject Securis Spinal Fixation System consist of screws of variou…
Custom Spine, Inc.20071
*K111099Issys LP Spinal Fixation System
Our reading of the summary gave K110099, FDA’s number for Proclear Toric XR Soft (Hydrophilic) Contact Lens… (CooperVision, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ISSYS LP”.
Custom Spine, Inc.20111
*K043522Issys Pedicle Screw System
Summary page 2
…System is similar in technology (interconnections between the polyaxial head and bone screw) as the previously cleared ISSYS LP ((K070821, K 072866, K110099) and ISSYS (K043522) Polyaxial Screw Systems. SERVICES Pu…
Custom Spine, Inc.2005—

Also cleared against K933881: 14 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 3 companies; a new generation was cleared every 1.2 years on median.
  • 8 of the 34 ancestors have a recall of any class.
  • 14 other devices also cite its predicate K933881.

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. 2012, 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 SECURIS Spinal Fixation System is intended for the immobilization and stabilization of the thoraco-lumbar-sacral spine (Ti-Si) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined by discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and previously failed fusion (pseudoarthrosis).

Indications for use as stated in the FDA summary.

Also cleared against K933881

14 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K160926F1 MPS Modular Pedicle Screw SystemDegen Medical · 2016
  • K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
  • K111099Issys LP Spinal Fixation SystemCustom Spine, Inc. · 20111 recall
  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010
  • K090648Viper 2 SystemDepuy Spine, Inc. · 2009

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/K113361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113361: Securis Spinal Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113361

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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