510(k) Report

510(k) · Cleared

Cleared

CalcaNail Orthopedic Nail

K150463510(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.

Other ancestors, by year cleared 2007: 1 other ancestor1999: 3 other ancestors2004: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1998: 3 other ancestors1997: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor1994: 1 other ancestor1993: 2 other ancestors1979: 1 other ancestorK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalledK021786 · Titanium Ankle Arthrodesis Nail · Biomet, Inc. · 2002 · recalledK050882 · Newdeal Ankle Nail · New Deal, S.A. · 2005 · recalledK091788 · Panta Nail (Dia. 10MM), Panta Nail XL · Newdeal Sas · 2009 · recalled1980199020002010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 8 other ancestors K091788 · Panta Nail (Dia. 10MM), Panta Nail XL · Newdeal Sas · 2009 · recalledK050882 · Newdeal Ankle Nail · New Deal, S.A. · 2005 · recalledK021786 · Titanium Ankle Arthrodesis Nail · Biomet, Inc. · 2002 · recalledK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalled0
  1. Root · 4 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
  2. 3 generations backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
  3. 2 generations backK050882 Newdeal Ankle NailNew Deal, S.A. · 2005 · Recalled
  4. 1 generation backK091788 Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas · 2009 · Recalled
  5. This deviceK150463 CalcaNail Orthopedic NailFournitures Hospitalieres Industrie · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K982953Titanium Intramedullary Nails-Various StylesBiomet, Inc.19984
−3K021786Titanium Ankle Arthrodesis NailBiomet, Inc.20021
−2K050882Newdeal Ankle NailNew Deal, S.A.20055
−1K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas20092
0 (this device)K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199320
199410
199610
199710
199830
199930
200010
200110
200210
200410
200710
FIG. 1 — Lineage of K150463, 1998–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

TypeNumberDeviceApplicantDecidedRecalls
*K991407Synthes Locking Calcaneal Plates
Summary page 5
…he components of the CalcaNail Orthopedic Nail are substantially equivalent to the following legally marketed devices: o Synthes calcaneal locking plate K991407 o FHI cannulated screws K070617 o NewDeal Panta Nail K091788 This statement is based on the similarity…
Synthes (Usa)1999—
*K070617Cannulated Screw
Summary page 5
…Nail are substantially equivalent to the following legally marketed devices: 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 de…
Fournitures Hospitalieres Industrie2007—
*K091788Panta Nail (Dia. 10MM), Panta Nail XL
Summary page 5
…e following legally marketed devices: 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…
Newdeal Sas20092

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

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
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

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

Indications for use as stated in the FDA summary.

Also cleared against K991407

15 other devices cite the same predicate.

  • K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH · 2026
  • K182818LOQTEQ VA Calcaneus Plate 3.5Aap Implantate AG · 2019
  • K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes · 2019
  • K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017
  • K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015

More from Fournitures Hospitalieres Industrie

24 FDA decisions under this applicant name. See the company

  • K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
  • K163148BePOD® Foot ScrewsFournitures Hospitalieres Industrie · 2017
  • K163710BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie · 2017
  • K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
  • K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K150463 · printed Nov 3, 2026

Cite this page

510(k) Report. “K150463: CalcaNail Orthopedic Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150463

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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