510(k) Report

510(k) · Cleared

Cleared

Eminent Spine 3D Titanium Pedicle Screw System

K241663510(k) TraditionalCleared Apr 28, 2025325-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

Eminent Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 28, 2025 as substantially equivalent to K100377 (Eminent Spine, 2010) and 6 other predicates after a 325-day review. Its family tree reaches back 5 generations to 1990.

Decided
Apr 28, 2025
Review
325 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K901587 (1990). 26 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 1 other ancestorK901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 1990K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997×2: 2 generations cleared close together, K973836 (1998), K974749 (1998) K100377 · Diamondback Spinal System · Eminent Spine · 20101990200020102020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 17 other ancestors K100377 · Diamondback Spinal System · Eminent Spine · 2010K974749 · Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems · Cross Medical Products, Inc. · 1998K973836 · Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System · Cross Medical Products, Inc. · 1998K950099 · Synergy (TM) TI Posterior Spinal System · Buckman Co., Inc. · 1997K901587 · TSRH Sacral L-Connector · Danek Medical, Inc. · 1990−50
  1. Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. 2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. 1 generation backK100377 Diamondback Spinal SystemEminent Spine · 2010
  6. This deviceK241663 Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K901587TSRH Sacral L-ConnectorDanek Medical, Inc.1990—
−4K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
−3K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
−2K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
−1K100377Diamondback Spinal SystemEminent Spine2010—
0 (this device)K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199250
199320
199420
199520
199610
199710
199810
199910
200010
200110
200210
200310
200410
FIG. 1 — Lineage of K241663, 1990–2025Source: 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? (7)

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
*K100377Diamondback Spinal System
Summary page 5
…evice Classification: Class II Reviewing Panel: Orthopedic Product Code: NKB Primary Predicate Device: Diamondback Spinal System (K100377) Additional Predicate Devices: Synergy CLS (Interpore Cross International (K950099/K974749) Moss Mi…
Eminent Spine2010—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 5
…uct Code: NKB Primary Predicate Device: Diamondback Spinal System (K100377) Additional Predicate Devices: Synergy CLS (Interpore Cross International (K950099/K974749) Moss Miami System (DuPuy, AcroMed, Inc. (K992168/K022623) CD…
Buckman Co., Inc.1997—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 5
…: NKB Primary Predicate Device: Diamondback Spinal System (K100377) Additional Predicate Devices: Synergy CLS (Interpore Cross International (K950099/K974749) Moss Miami System (DuPuy, AcroMed, Inc. (K992168/K022623) CD Horizon…
Cross Medical Products, Inc.1998—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 5
…100377) Additional Predicate Devices: Synergy CLS (Interpore Cross International (K950099/K974749) Moss Miami System (DuPuy, AcroMed, Inc. (K992168/K022623) CD Horizon (Medtronic Sofamor Danek (K031655/K041460) Device Description: The Eminent Spi…
Depuyacromed1999—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 5
…Additional Predicate Devices: Synergy CLS (Interpore Cross International (K950099/K974749) Moss Miami System (DuPuy, AcroMed, Inc. (K992168/K022623) CD Horizon (Medtronic Sofamor Danek (K031655/K041460) Device Description: The Eminent Spine 3D Ti…
Depuyacromed2002—
*K031655CD Horizon Spinal System
Summary page 5
…50099/K974749) Moss Miami System (DuPuy, AcroMed, Inc. (K992168/K022623) CD Horizon (Medtronic Sofamor Danek (K031655/K041460) Device Description: The Eminent Spine 3D Titanium Pedicle Screw System consists of rods, polyaxial screws with set caps…
Medtronic Sofamor Danek USA, Inc.20031
*K041460CD Horizon Spinal System
Summary page 5
…74749) Moss Miami System (DuPuy, AcroMed, Inc. (K992168/K022623) CD Horizon (Medtronic Sofamor Danek (K031655/K041460) Device Description: The Eminent Spine 3D Titanium Pedicle Screw System consists of rods, polyaxial screws with set caps, and cr…
Medtronic Sofamor Danek USA, Inc.2004—

Also cleared against K100377: 3 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 35 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
  • 1 of the 26 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K100377.

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. 2025, 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 Eminent Spine 3D Titanium Pedicle Screw System is designed to provide immobilization and stabilization to the thoracic, lumbar and sacral spinal segments as an adjunct to fusion. The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 or 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K100377

3 other devices cite the same predicate.

  • K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine · 2024
  • K111301Instinct Java SystemZimmer Spine · 20111 recall
  • K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG · 20111 recall

More from Eminent Spine

11 FDA decisions under this applicant name. See the company

  • K250894Eminent Spine Posterior SI SystemEminent Spine · 2025
  • K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine · 2024
  • K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine · 2023
  • K221936Standalone ALIF Interbody Fusion SystemEminent Spine · 2022
  • K143365Eminent Foot Plate SystemEminent Spine · 2015

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/K241663 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241663: Eminent Spine 3D Titanium 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/K241663

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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