510(k) · Cleared

Cleared

Ace Aim TTC Fusion Nail

K003797510(k) SpecialCleared Dec 15, 20007-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

DePuy Orthopaedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 15, 2000 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 53 later devices descend from it.

Decided: Dec 15, 2000
Review: 7 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 0

53 later devices descend from it, 4 citing it directly.

This deviceK003797 Ace Aim TTC Fusion NailDePuy Orthopaedics, Inc. · 2000
Descendant · cites it directly · 41 of its ownK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
Descendant · 2 generations on · 25 of its ownK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
Descendant · 2 generations on · 24 of its ownK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
Descendant · 3 generations on · 22 of its ownK171376 DynaNail TTC Fusion SystemMedShape, Inc. · 2017
Descendant · 2 generations on · 15 of its ownK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2001high 7 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 53 · See all

K023115Ace VersanailDePuy Orthopaedics, Inc. · 2002 · cites it directly41descendants
K101934Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222…Medshape Solutions · 2011 · 2 generations on25descendants
K113828Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012 · 2 generations on24descendants
K171376DynaNail TTC Fusion SystemMedShape, Inc. · 2017 · 3 generations on22descendants
K050882Newdeal Ankle NailNew Deal, S.A. · 2005 · 2 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003797	Ace Aim TTC Fusion Nail	DePuy Orthopaedics, Inc.	2000	—
+1	K023115	Ace Versanail	DePuy Orthopaedics, Inc.	2002	—
+2	K101934	Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models…	Medshape Solutions	2011	—
+2	K113828	Dynanail Ankle Arthrodesis Nail	MedShape, Inc.	2012	—
+3	K171376	DynaNail TTC Fusion System	MedShape, Inc.	2017	—
+2	K050882	Newdeal Ankle Nail	New Deal, S.A.	2005	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2005	1	0
2008	1	0
2009	1	0
2011	2	0
2012	3	0
2013	3	0
2014	1	0
2015	2	0
2017	1	0
2018	3	0
2019	4	0
2020	5	0
2021	3	0
2022	2	0
2023	3	0
2024	3	0
2025	6	0
2026	7	0

FIG. 1 — Lineage of K003797, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K023115	Ace Versanail	DePuy Orthopaedics, Inc.	2002	41
K012190	Aos Modular Femoral Nail	Advanced Orthopaedic Solutions, Inc.	2001	10
K121575	Oxford Ankle Fusion Nail (Afn) System	Ortho Solutions Limited	2012	1
K111663	Trauma Internal Fixation Systems	DePuy Orthopaedics, Inc.	2012	1

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?

Of its descendants, K023115 (DePuy Orthopaedics, Inc., 2002) has gone furthest, with 41 descendants of its own.

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.

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	—

https://510kreport.com/device/K003797 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003797: Ace Aim TTC Fusion Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003797

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026