510(k) Report

510(k) · Cleared

Cleared

Athena Pedicle Screw System

K110046510(k) TraditionalCleared Dec 7, 2011335-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

Royal Oak Medical Devices · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 7, 2011 as substantially equivalent to K950099 (Buckman Co., Inc., 1997) and 5 other predicates after a 335-day review. Its family tree reaches back 4 generations to 1990.

Decided
Dec 7, 2011
Review
335 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K901587 (1990). 28 ancestors in all, the oldest K884263 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1995: 4 other ancestors2000: 1 other ancestor1997: 2 other ancestors1996: 1 other ancestor1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1988: 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) 198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 20 other ancestors K974749 · 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. · 19900
  1. Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
  2. 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  3. 2 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  4. 1 generation backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  5. This deviceK110046 Athena Pedicle Screw SystemRoyal Oak Medical Devices · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K901587TSRH Sacral L-ConnectorDanek Medical, Inc.1990—
−3K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc.1997—
−2K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
−1K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
0 (this device)K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199020
199250
199320
199420
199540
199610
199720
199820
199910
200010
200210
FIG. 1 — Lineage of K110046, 1990–2011Source: 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? (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
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 2
…substantially equivalent to the Interpore Cross Synergy Polyaxial System (K950099/K974749), Rogozinski System (K930298/K953904) and Depuy Spine Moss…
Buckman Co., Inc.1997—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 2
…ntially equivalent to the Interpore Cross Synergy Polyaxial System (K950099/K974749), Rogozinski System (K930298/K953904) and Depuy Spine Moss…
Cross Medical Products, Inc.1998—
*K930298Rogozinski Spinal Rod System Screw
Summary page 2
…Cross Synergy Polyaxial System (K950099/K974749), Rogozinski System (K930298/K953904) and Depuy Spine Moss Miami System (K992168/K022623) DEVICE DESCRIPTION T…
Smith & Nephew Richards, Inc.1995—
*K983904Rogozinski Spinal Rod System
Our reading of the summary gave K953904, FDA’s number for Sarns 9000 Universal Roller Pump (3M Health Care, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Rogozinski System”.
United States Surgical, A Division of Tyco Healthc1998—
*K992168Moss Miami 6.35MM Polyaxial Screw
Summary page 2
…49), Rogozinski System (K930298/K953904) and Depuy Spine Moss Miami System (K992168/K022623) DEVICE DESCRIPTION The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and le…
Depuyacromed1999—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 2
…ozinski System (K930298/K953904) and Depuy Spine Moss Miami System (K992168/K022623) DEVICE DESCRIPTION The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, s…
Depuyacromed2002—

Also cleared against K950099: 34 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 21 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
  • None of the 28 ancestors has a recall.
  • 34 other devices also cite its predicate K950099.

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. 2011, 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 Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation 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 (ODD) (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 (ie., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrcsis; and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K950099

34 other devices cite the same predicate.

  • K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine · 2025
  • K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  • K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC · 2017
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
  • K143683APEX-DL Spine SystemSpinecraft, LLC · 2015
  • K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC · 20151 recall

More from Royal Oak Medical Devices

2 FDA decisions under this applicant name. See the company

  • K110177Helena SystemRoyal Oak Medical Devices · 2011

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/K110046 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110046: Athena Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110046

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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