510(k) Report

510(k) · Cleared

Cleared

DYNAMIS™ Navigation System

K252962510(k) TraditionalCleared Jan 12, 2026118-day reviewClass II21 CFR 882.4560

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

Promethean Restorative, LLC · OLO Orthopedic Stereotaxic Instrument

Cleared on Jan 12, 2026 as substantially equivalent to K181606 (Precision Spine, Inc., 2019) and 3 other predicates after a 118-day review. Its family tree reaches back 22 generations to 2004.

Decided
Jan 12, 2026
Review
118 days
Class
Class II
Product code
OLO
Recalls
None
Predicates
4

Its longest line of descent runs back 22 generations to K040583 (2004). 195 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2025: 1 other ancestor2019: 2 other ancestors2014: 4 other ancestors2023: 1 other ancestor2021: 1 other ancestor2020: 2 other ancestors2018: 3 other ancestors2016: 3 other ancestors2013: 5 other ancestors2011: 3 other ancestors2006: 10 other ancestors2015: 4 other ancestors2012: 2 other ancestors2008: 5 other ancestors2005: 16 other ancestors2004: 22 other ancestors2003: 8 other ancestors2002: 8 other ancestors2000: 11 other ancestors1999: 3 other ancestors2017: 3 other ancestors2010: 4 other ancestors2009: 2 other ancestors2001: 10 other ancestors1997: 5 other ancestors1994: 4 other ancestors2007: 4 other ancestors1998: 6 other ancestors1996: 2 other ancestors1995: 7 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 2 other ancestors1989: 1 other ancestor1986: 2 other ancestors1984: 2 other ancestors1985: 1 other ancestor1990: 1 other ancestorReference device: K251075 · DYNAMIS™ Implant System · Promethean Restorative, LLC · 2025×7: 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) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017×2: 2 generations cleared close together, K191148 (2019), K193011 (2020) K201362 · CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement · Medtronic · 2020K210637 · CD Horizon™ Spinal System · Medtronic · 202119801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 27 other ancestors4 generations back: 37 other ancestors5 generations back: 40 other ancestors6 generations back: 28 other ancestors7 generations back: 21 other ancestors8 generations back: 7 other ancestors K210637 · CD Horizon™ Spinal System · Medtronic · 2021K201362 · CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement · Medtronic · 2020K193011 · CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 2020K191148 · Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set · Medtronic Sofamor Danek USA, Inc. · 2019K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · 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 · 2004−20−15−10−50
  1. Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations between
  3. 3 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
  4. 2 generations backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
  5. 1 generation backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
  6. This deviceK252962 DYNAMIS™ Navigation SystemPromethean Restorative, LLC · 2026
Show all 22 generations
  1. Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 9 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 8 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 7 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 6 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 5 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 4 generations backK191148 Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc. · 2019
  20. 3 generations backK193011 CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. · 2020
  21. 2 generations backK201362 CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System…Medtronic · 2020
  22. 1 generation backK210637 CD Horizon™ Spinal SystemMedtronic · 2021
  23. This deviceK252962 DYNAMIS™ Navigation SystemPromethean Restorative, LLC · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−21K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−19K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−18K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−17K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−16K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−15K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−14K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−13K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−12K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−11K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−10K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−9K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−4K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™…Medtronic Sofamor Danek USA, Inc.2019—
−3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.2020—
−2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™…Medtronic2020—
−1K210637CD Horizon™ Spinal SystemMedtronic2021—
0 (this device)K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198510
198620
198710
198820
198910
199010
199220
199440
199570
199620
199750
199860
199930
2000110
2001100
200280
200380
2004220
2005160
2006100
200740
200850
200920
201040
201130
201220
201350
201440
201540
201630
201730
201830
201920
202020
202110
202310
202510
FIG. 1 — Lineage of K252962, 2004–2026Source: 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 OLO? 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 OLO device

  1. #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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? (4)

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
*K181606Precision Spine Navigation Instrumentation
Summary page 5
…21 CFR §882.4560 Class: II Product Code: OLO Primary Predicate: Precision Spine Navigation System (K181606) Additional Predicates: Medtronic Navigated Reusable Instruments for use with StealthStation™…
Precision Spine, Inc.2019—
*K210637CD Horizon™ Spinal System
Summary page 5
…81606) Additional Predicates: Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ Powerease™ Systems (K210637) Navigated CD Horizon Solera Screwdriver/Taps (K140454) Innovasis…
Medtronic2021—
*K140454Navigated CD Horizon Solera Screwdriver/Taps
Summary page 5
…with StealthStation™ and IPC™ Powerease™ Systems (K210637) Navigated CD Horizon Solera Screwdriver/Taps (K140454) Innovasis Navigation Instruments (K250182) Reference Device: DYNAMIS™ Implant Syst…
Medtronic Sofamor Danek USA, Inc.20141
*K250182Innovasis Navigation Instruments
Summary page 5
…ystems (K210637) Navigated CD Horizon Solera Screwdriver/Taps (K140454) Innovasis Navigation Instruments (K250182) Reference Device: DYNAMIS™ Implant System (K251075) Device Description: The DYNAMIS™ Navigation System consists o…
Innovasis, Inc.20251
†K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC2025—

Also cleared against K181606: 2 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 22 years and passes through 5 companies; a new generation was cleared every 7 months on median.
  • 28 of the 195 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K181606.

How does its category compare?

All OLO devices

OLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · OLO

40in 2025

2009: 112010: 92011: 112012: 72013: 72014: 102015: 102016: 142017: 332018: 242019: 352020: 342021: 282022: 402023: 452024: 442025: 402026 (partial year): 42
2007high 45 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLO

119in 2025

2009: 126 days median2010: 113 days median2011: 138 days median2012: 129 days median2013: 137 days median2014: 119 days median2015: 176 days median2016: 120 days median2017: 91 days median2018: 97 days median2019: 95 days median2020: 89 days median2021: 91 days median2022: 89 days median2023: 90 days median2024: 90 days median2025: 119 days median2026 (partial year): 109 days median
2007high 176 (2015) · low 89 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OLO

1in 2025

2010: 12011: 12012: 12014: 32015: 22016: 32017: 22018: 12019: 12020: 62022: 52023: 7, 1 Class I2024: 42025: 12026 (partial year): 6
2007high 7 (2023) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OLO

3,306in 2025

2008: 12009: 42010: 42011: 102012: 602013: 362014: 2452015: 4662016: 7502017: 1,0762018: 1,2302019: 1,5852020: 2,7462021: 1,6962022: 1,5682023: 1,4932024: 2,3532025: 3,306
2007high 3,306 (2025) · low 0 (2007)2025

MAUDE reports naming product code OLO, 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
20070—00
20080—01
20091112604
2010911314
201111138110
20127129160
20137137036
2014101193245
2015101762466
2016141203750
2017339121,076
2018249711,230
2019359511,585
2020348962,746
2021289101,696
2022408951,568
202345907 (1)1,493
2024449042,353
20254011913,306
2026421096—

What is it indicated for?

The DYNAMIS™ Navigation System is intended to be used in the preparation and placement of the DYNAMIS™ Implant System during sacroiliac joint fusion surgery and fracture fixation of the pelvis to assist the surgeon in guiding instrument placement and implant positioning, in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis, or vertebra, can be identified relative to the…

Read the full statement (109 words)

The DYNAMIS™ Navigation System is intended to be used in the preparation and placement of the DYNAMIS™ Implant System during sacroiliac joint fusion surgery and fracture fixation of the pelvis to assist the surgeon in guiding instrument placement and implant positioning, in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis, or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image based model of the anatomy.

The DYNAMIS™ Navigation System is intended to be used with the Medtronic StealthStation S8 System, Software Version 2.1.

Indications for use as stated in the FDA summary.

Also cleared against K181606

2 other devices cite the same predicate.

  • K240963Spinal SystemTeslake, Inc. · 2024
  • K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc. · 2023

More from Promethean Restorative, LLC

3 FDA decisions under this applicant name. See the company

  • K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC · 2025
  • K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC · 2025

Recent decisions in OLO

The OLO category page

  • K2604037D Surgical System (10-0001)7D Surgical ULC · 2026
  • K263234TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
  • K263154CarboClear® Cervical Navigated InstrumentsCarboFix Orhtopedics, Ltd. · 2026
  • K262257Spine Planning (3.0); Spine & Trauma Navigation; Alignment System SpineBrainlab SE · 2026
  • K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026

https://510kreport.com/device/K252962 · printed Nov 5, 2026

Cite this page

510(k) Report. “K252962: DYNAMIS™ Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252962

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