510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Tilock Pedicle Screw System

K100757510(k) TraditionalCleared Jul 1, 2010106-day reviewClass II21 CFR 888.3070Recalls 1

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

Genesys Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 1, 2010 as substantially equivalent to K984578 (Interpore Cross Intl., 1999) and 5 other predicates after a 106-day review. Its family tree reaches back 5 generations to 1996. 9 later devices descend from it. It has been recalled once.

Decided
Jul 1, 2010
Review
106 days
Class
Class II
Product code
NKB
Recalls
1
Predicates
6

Its longest line of descent runs back 5 generations to K955348 (1996). 28 ancestors in all, the oldest K884263 (1988). 9 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 3 other ancestors1999: 2 other ancestors1998: 5 other ancestors2003: 2 other ancestors2001: 2 other ancestors1997: 1 other ancestor1996: 2 other ancestors1995: 4 other ancestors1990: 1 other ancestor1988: 1 other ancestor2011: 1 descendant cleared2017: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants clearedK955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 1996K062196 · SFX Snap-Fit Cross Connector · Depuy Spine, Inc. · 2006K071495 · Expedium 4.5MM Spine System · Depuy Spine, A Johnson & Johnson Company · 2007×2: 2 generations cleared close together, K073364 (2008), K081252 (2008) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 10 other ancestors3 generations back: 7 other ancestors4 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K081252 · Expedium 4.5MM Spine System · Depuy Spine, Inc. · 2008K073364 · Expedium 4.5MM Spine System · Depuy Spine, Inc. · 2008K071495 · Expedium 4.5MM Spine System · Depuy Spine, A Johnson & Johnson Company · 2007K062196 · SFX Snap-Fit Cross Connector · Depuy Spine, Inc. · 2006K955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 1996−50
  1. Root · 5 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
  2. 4 generations backK062196 SFX Snap-Fit Cross ConnectorDepuy Spine, Inc. · 2006
  3. 3 generations backK071495 Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007
  4. 2 generations backK073364 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
  5. 1 generation backK081252 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
  6. This deviceK100757 Tilock Pedicle Screw SystemGenesys Spine · 2010
  7. Descendant · cites it directly · 8 of its ownK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
  8. Descendant · cites it directly · 7 of its ownK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
  9. Descendant · cites it directly · 4 of its ownK171838 TiLock2 Spinal SystemGenesys Spine · 2017
  10. Descendant · 2 generations on · 2 of its ownK201427 Trivergent Spinal Fixation SystemBenvenue Medical, Inc. · 2020
  11. Descendant · 3 generations on · 1 of its ownK253169 Duet™ Spinal Fixation SystemBox Spine, LLC · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011: 12015: 12016: 12017: 22020: 12025: 12026: 2
2011high 2 (2017) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all
  • K103671Genesys Spine Tilock SystemGenesys Spine · 2011 · cites it directly8descendants
  • K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015 · cites it directly7descendants
  • K171838TiLock2 Spinal SystemGenesys Spine · 2017 · cites it directly4descendants
  • K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc. · 2020 · 2 generations on2descendants
  • K253169Duet™ Spinal Fixation SystemBox Spine, LLC · 2026 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K955348Titanium Moss Miami Spinal SystemDepuy, Inc.1996—
−4K062196SFX Snap-Fit Cross ConnectorDepuy Spine, Inc.2006—
−3K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company2007—
−2K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008—
−1K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008—
0 (this device)K100757Tilock Pedicle Screw SystemGenesys Spine2010—
+1K103671Genesys Spine Tilock SystemGenesys Spine2011—
+1K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine2015—
+1K171838TiLock2 Spinal SystemGenesys Spine2017—
+2K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.2020—
+3K253169Duet™ Spinal Fixation SystemBox Spine, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199540
199620
199710
199850
199920
200120
200320
200430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201510
201610
201720
202010
202510
202620
FIG. 1 — Lineage of K100757, 1996–2026Source: 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
Get a 510(k) Report

What was it cleared against? (6)

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
*K984578Synergy D2 Spinal Implants
Summary page 2
…CAL CHARACTERISTICS The Genesys Spine TiLock System was determined to be substantially equivalent to the following predicate systems: Interpore Cross Synergy Polyaxial (K984578) DePuy Spine Expedium (K081252, K041 801) DePuy Spine Moss Miami (K955348) DePuy Spine VSP Spine System (K984350) US Surgical Rog…
Interpore Cross Intl.1999—
*K081252Expedium 4.5MM Spine System
Summary page 2
…s Spine TiLock System was determined to be substantially equivalent to the following predicate systems: Interpore Cross Synergy Polyaxial (K984578) DePuy Spine Expedium (K081252, K041 801) DePuy Spine Moss Miami (K955348) DePuy Spine VSP Spine System (K984350) US Surgical Rogozinski Spinal Rod System (K983…
Depuy Spine, Inc.2008—
*K041801Expedium Mis Spine System
Summary page 2
…iLock System was determined to be substantially equivalent to the following predicate systems: Interpore Cross Synergy Polyaxial (K984578) DePuy Spine Expedium (K081252, K041 801) DePuy Spine Moss Miami (K955348) DePuy Spine VSP Spine System (K984350) US Surgical Rogozinski Spinal Rod System (K983904) The…
Depuy Spine, Inc.2004—
*K955348Titanium Moss Miami Spinal System
Summary page 2
…substantially equivalent to the following predicate systems: Interpore Cross Synergy Polyaxial (K984578) DePuy Spine Expedium (K081252, K041 801) DePuy Spine Moss Miami (K955348) DePuy Spine VSP Spine System (K984350) US Surgical Rogozinski Spinal Rod System (K983904) The subject and predicate device shar…
Depuy, Inc.1996—
*K984350VSP System
Summary page 2
…ng predicate systems: Interpore Cross Synergy Polyaxial (K984578) DePuy Spine Expedium (K081252, K041 801) DePuy Spine Moss Miami (K955348) DePuy Spine VSP Spine System (K984350) US Surgical Rogozinski Spinal Rod System (K983904) The subject and predicate device share the same intended use and material of…
Depuy Motech Acromed1999—
*K983904Rogozinski Spinal Rod System
Summary page 2
…xial (K984578) DePuy Spine Expedium (K081252, K041 801) DePuy Spine Moss Miami (K955348) DePuy Spine VSP Spine System (K984350) US Surgical Rogozinski Spinal Rod System (K983904) The subject and predicate device share the same intended use and material of manufacture. The subject and predicate device have…
United States Surgical, A Division of Tyco Healthc1998—

Also cleared against K984578: 4 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K103671Genesys Spine Tilock SystemGenesys Spine20118
K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157
K171838TiLock2 Spinal SystemGenesys Spine20174
K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161
K172469TiLock Modular Spinal SystemGenesys Spine20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 2, 2014Class IIZ-2677-2014Nonconforming Material/ComponentThe recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 10 months on median.
  • None of the 28 ancestors has a recall.
  • Of its descendants, K103671 (Genesys Spine, 2011) has gone furthest, with 8 descendants of its own.
  • 4 other devices also cite its predicate K984578.

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. 2010, 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 TiLock Pedicle Screw System is intended 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 disc disease (DDD) (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, kyph~osis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K984578

4 other devices cite the same predicate.

  • K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A. · 2016
  • K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
  • K142576Spinal SystemEisertech, LLC · 20151 recall
  • K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc. · 2013

More from Genesys Spine

31 FDA decisions under this applicant name. See the company

  • K252322SIros-X SystemGenesys Spine · 2025
  • K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine · 2025
  • K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine · 2024
  • K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023
  • K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2022

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/K100757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100757: Tilock Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100757

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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