510(k) · Cleared

Cleared

CalcaNail Orthopedic Arthrodesis Nail

K150471510(k) TraditionalCleared May 22, 201588-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

Fournitures Hospitalieres Industrie · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 22, 2015 as substantially equivalent to K991407 (Synthes (Usa), 1999) and 2 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1998.

Decided: May 22, 2015
Review: 88 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K982953 (1998). 21 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
3 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
2 generations backK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
1 generation backK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
This deviceK150471 CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K982953	Titanium Intramedullary Nails-Various Styles	Biomet, Inc.	1998	4
−3	K021786	Titanium Ankle Arthrodesis Nail	Biomet, Inc.	2002	1
−2	K050882	Newdeal Ankle Nail	New Deal, S.A.	2005	5
−1	K091788	Panta Nail (Dia. 10MM), Panta Nail XL	Newdeal Sas	2009	2
0 (this device)	K150471	CalcaNail Orthopedic Arthrodesis Nail	Fournitures Hospitalieres Industrie	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1993	2	0
1994	1	0
1996	1	0
1997	1	0
1998	3	0
1999	3	0
2000	1	0
2001	1	0
2002	1	0
2004	1	0
2007	1	0

FIG. 1 — Lineage of K150471, 1998–2015Source: 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? (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
*	K991407	Synthes Locking Calcaneal Plates Summary page 5 …d devices: FOURNITURES HOSPITALIERES INDUSTRIE CalcaNail Orthopedic Arthrodesis Nail Page 5 -1 K150471 (page 2 of 3) o Synthes Calcaneal Locking Plate K991407 o FHI Cannulated Screws K070617 o NewDeal Panta Nail K091788 This statement is based on the similarity of the subject device to…	Synthes (Usa)	1999	—
*	K070617	Cannulated Screw Summary page 5 …IERES INDUSTRIE CalcaNail Orthopedic Arthrodesis Nail Page 5 -1 K150471 (page 2 of 3) o Synthes Calcaneal Locking Plate K991407 o FHI Cannulated Screws K070617 o NewDeal Panta Nail K091788 This statement is based on the similarity of the subject device to the predicate devices in one or…	Fournitures Hospitalieres Industrie	2007	—
*	K091788	Panta Nail (Dia. 10MM), Panta Nail XL Summary page 5 …hopedic Arthrodesis Nail Page 5 -1 K150471 (page 2 of 3) o Synthes Calcaneal Locking Plate K991407 o FHI Cannulated Screws K070617 o NewDeal Panta Nail K091788 This statement is based on the similarity of the subject device to the predicate devices in one or more of intended use, materia…	Newdeal Sas	2009	2

Also cleared against K991407: 15 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 17 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
6 of the 21 ancestors have a recall of any class.
15 other devices also cite its predicate K991407.

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. 2015, 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 CalcaNail Orthopedic Arthrodesis Nail is intended for subtalar arthrodesis in the treatment of patients with:

- Comminuted fractures of the calcaneus

- Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae

- Osteoarthritis of the posterior subtalar joint, or

- Valgus flatfoot deformities

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K150471 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150471: CalcaNail Orthopedic Arthrodesis Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150471

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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