510(k) · Cleared

Cleared

Revolution Femoral Intramedullary Nail System, Model Dgooxx

K091309510(k) TraditionalCleared Nov 5, 2009185-day reviewClass II21 CFR 888.3020

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

Dgimed Ortho, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Nov 5, 2009 as substantially equivalent to K893377 (Richards Medical Co., Inc., 1989) and 2 other predicates after a 185-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.

Decided: Nov 5, 2009
Review: 185 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K893377 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK893377 Russell-Taylor Intramedullary Knee Fusion NailsRichards Medical Co., Inc. · 1989
This deviceK091309 Revolution Femoral Intramedullary Nail System, Model DgooxxDgimed Ortho, Inc. · 2009
Descendant · cites it directly · 0 of its ownK100312 Distalock Femoral Intramedullary Nail SystemDgimed Ortho, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all

K100312Distalock Femoral Intramedullary Nail SystemDgimed Ortho, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K893377	Russell-Taylor Intramedullary Knee Fusion Nails	Richards Medical Co., Inc.	1989	—
0 (this device)	K091309	Revolution Femoral Intramedullary Nail System, Model Dgooxx	Dgimed Ortho, Inc.	2009	—
+1	K100312	Distalock Femoral Intramedullary Nail System	Dgimed Ortho, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K091309, 1989–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HSB? 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 HSB device

#1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K893377	Russell-Taylor Intramedullary Knee Fusion Nails Summary page 1 …ate Devices Device Manufacturer 510(k) Status Russell-Taylor Femoral Nail Smith & Nephew K893377 Cannulated Retrograde/Antegrade Synthes K033618 Fernoral Nail EXPERT System T2 Femoral Nailing Syst…	Richards Medical Co., Inc.	1989	—
*	K033618	Synthes (Usa) Retrograde/Antegrade Femoral Nail System Summary page 1 …510(k) Status Russell-Taylor Femoral Nail Smith & Nephew K893377 Cannulated Retrograde/Antegrade Synthes K033618 Fernoral Nail EXPERT System T2 Femoral Nailing System Stryker Corp. K912930 6.1 Device Descript…	Synthes (Usa)	2004	1
*	K912930	Interlocking Femoral Nailing System Summary page 1 …ated Retrograde/Antegrade Synthes K033618 Fernoral Nail EXPERT System T2 Femoral Nailing System Stryker Corp. K912930 6.1 Device Description The Revolution Femnoral Intramedullary Nail System permits an antegrade intramedullary approach for f…	Stryker Corp.	1992	—

Also cleared against K893377: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100312	Distalock Femoral Intramedullary Nail System	Dgimed Ortho, Inc.	2010	0

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K100312 (Dgimed Ortho, Inc., 2010) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K893377.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2007high 81 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSB

2,911in 2025

2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

What is it indicated for?

The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple traumna patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or imalunions and nonunions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091309 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091309: Revolution Femoral Intramedullary Nail System, Model Dgooxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091309

Report an extraction error

Are you the manufacturer?

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