510(k) · Cleared

Cleared

Orthofix Ankle Hindfoot Nailing System

K141571510(k) TraditionalCleared Nov 12, 2014153-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

Orthofix Srl · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Nov 12, 2014 as substantially equivalent to K091976 (Biomet Trauma, 2009) after a 153-day review. Its family tree reaches back 1 generation to 2009.

Decided: Nov 12, 2014
Review: 153 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K091976 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK091976 Biomet Phoenix Ankle Nail and Ankle Arthrodesis NailBiomet Trauma · 2009 · Recalled
This deviceK141571 Orthofix Ankle Hindfoot Nailing SystemOrthofix Srl · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K091976	Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail	Biomet Trauma	2009	2
0 (this device)	K141571	Orthofix Ankle Hindfoot Nailing System	Orthofix Srl	2014	—

FIG. 1 — Lineage of K141571, 2009–2014Source: 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

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What was it cleared against? (1)

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
*	K091976	Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail Summary page 5 …s Classification: Class II – 21 CFR § 888.3020 – Intramedullary Fixation Rod Predicate Device: Biomet Phoenix Ankle Arthrodesis Nail System – K091976 Device Description: The Orthofix Ankle Hindfoot Nailing System comprises a variety of im…	Biomet Trauma	2009	2

Also cleared against K091976: 5 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?

Its one ancestor has a recall.
5 other devices also cite its predicate K091976.

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. 2014, 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 Orthofix Ankle Hindfoot Nailing System is intended to facilitate tibiotalocalcaneal arthrodesis (fusion). Specific indications include:

1. Avascular necrosis of the talus

2. Failed total ankle arthroplasty

3. Trauma (malunited tibial pilon fracture)

4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease

5. Revision ankle arthrodesis

6. Neuroarthropathy

7. Rheumatoid arthritis

8. Osteoarthritis

9. Pseudoarthrosis

10. Post-traumatic arthrosis

11. Previously infected arthrosis

12. Charcot foot

13. Severe endstage degenerative arthritis

14. Severe defects after tumor resection

15. Pantalar arthrodesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141571 · printed Nov 5, 2026

Cite this page

510(k) Report. “K141571: Orthofix Ankle Hindfoot Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141571

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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