510(k) · Cleared

Cleared

Dyna Locking Ankle Nail

K120419510(k) TraditionalCleared May 21, 2012101-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

U&I Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 21, 2012 as substantially equivalent to K860756 (Howmedica Corp., 1986) and 2 other predicates after a 101-day review. Its family tree reaches back 2 generations to 1998. 9 later devices descend from it.

Decided: May 21, 2012
Review: 101 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K982953 (1998). 4 ancestors in all, the oldest K860756 (1986). 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
1 generation backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
This deviceK120419 Dyna Locking Ankle NailU&I Corp. · 2012
Descendant · cites it directly · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
Descendant · cites it directly · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
Descendant · 2 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
Descendant · 2 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
Descendant · 3 generations on · 2 of its ownK210869 Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2019high 2 (2019) · low 0 (2022)2026

Most influential descendants

Showing 5 of 9 · See all

K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · cites it directly8descendants
K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · cites it directly6descendants
K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on6descendants
K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 2 generations on5descendants
K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2021 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K982953	Titanium Intramedullary Nails-Various Styles	Biomet, Inc.	1998	4
−1	K021786	Titanium Ankle Arthrodesis Nail	Biomet, Inc.	2002	1
0 (this device)	K120419	Dyna Locking Ankle Nail	U&I Corp.	2012	—
+1	K182307	Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…	Paragon 28, Inc.	2019	—
+1	K192163	TTC Phantom® Intramedullary Nail System	Paragon 28, Inc.	2020	—
+2	K191782	TTC Phantom Intramedullary Nail System	Paragon 28, Inc.	2019	—
+2	K201227	Phantom® Hindfoot TTC/TC Nail System	Paragon 28, Inc.	2020	—
+3	K210869	Phantom Hindfoot TTC/TC Nail System	Paragon 28, Inc.	2021	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	2	0
2020	2	0
2021	1	0
2023	1	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K120419, 1998–2026Source: 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
*	K860756	Grosse and Kempf Locking Nail System, Non-Slot Rod Summary page 1 …ion Name: Intramedullary Fixation Rod (HSB), per 21 CFR 885.3020 Product Code: HSB Predicate Devices: Grosse & Kempf Locking Nail System (K860756) T2 Ankle Arthrodesis Nail (KO5i 590) Titanium Ankle Arthrodesis Nail (K0…	Howmedica Corp.	1986	—
*	K051590	T2 Ankle Arthrodesis Nail Summary page 2 …joint Substantial Equivalence: The Dyna Locking Ankle NaITM is substantially equivalent to Grosse and Kempf Locking Nail System (K860756), T2 Ankle Arthrodesis Nail (K051590), Titanium Ankle Arthrodesis Nail (K021786) in design, performance, function and intended use. 1. Comparison Technological C…	Howmedica Osteonics Corp.	2005	8
*	K021786	Titanium Ankle Arthrodesis Nail Summary page 1 …rosse & Kempf Locking Nail System (K860756) T2 Ankle Arthrodesis Nail (KO5i 590) Titanium Ankle Arthrodesis Nail (K021 786) Description of Device: The Dyna Locking Ankle Na/TM consists of Ankle Nail, Locking Screw, Set Screw, and End Cap. The Ankle n…	Biomet, Inc.	2002	1

Also cleared against K860756: 3 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K182307	Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System	Paragon 28, Inc.	2019	8
K192163	TTC Phantom® Intramedullary Nail System	Paragon 28, Inc.	2020	6

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 14 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
3 of the 4 ancestors have a recall of any class.
Of its descendants, K182307 (Paragon 28, Inc., 2019) has gone furthest, with 8 descendants of its own.
3 other devices also cite its predicate K860756.

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. 2012, 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 Dyna Locking Ankle Nailm is used in various indications as follows.

* Post-traumatic and degenerative arthritis involving both ankle and subtalar joints

* Rheumatoid arthritis

* Revision of failed ankle arthrodesis with subtalar involvement of with an insufficient talar body

* Revision of failed total ankle arthroplasty with subtalar intrusion

* Talar deficiency conditions requiring tibiocalcaneal arthrodesis

* Avascular necrosis of the talus

* Neuroarthropathy or neuropathic ankle deformity

* Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease

* Severe pilon fractures with trauma to the subtalar joint

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120419 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120419: Dyna Locking Ankle Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120419

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