510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail

K091976510(k) TraditionalCleared Aug 17, 200947-day reviewClass II21 CFR 888.3020Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomet Trauma · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Aug 17, 2009 after a 47-day review. The FDA summary names no predicate by number. 23 later devices descend from it. It has been recalled 2 times.

Decided
Aug 17, 2009
Review
47 days
Class
Class II
Product code
HSB
Recalls
2
Predicates
0

23 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2024: 2 descendants cleared2014: 1 descendant cleared2012: 2 descendants cleared2010: 1 descendant cleared2017: 3 descendants cleared2025: 2 descendants cleared2015: 1 descendant cleared2019: 2 descendants cleared2026: 2 descendants cleared2016: 1 descendant cleared2023: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK091976 Biomet Phoenix Ankle Nail and Ankle Arthrodesis NailBiomet Trauma · 2009
  2. Descendant · cites it directly · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  3. Descendant · 2 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  4. Descendant · 3 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
  5. Descendant · 3 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
  6. Descendant · 4 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2010: 12012: 22013: 22014: 12015: 12016: 12017: 32019: 22020: 22021: 12023: 12024: 22025: 22026: 2
2010high 3 (2017) · low 0 (2011)2026

Most influential descendants

Showing 5 of 23 · See all
  • K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · cites it directly14descendants
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on8descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 3 generations on6descendants
  • K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on6descendants
  • K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K091976Biomet Phoenix Ankle Nail and Ankle Arthrodesis NailBiomet Trauma2009—
+1K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.2013—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.2019—
+4K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201220
201320
201410
201510
201610
201730
201920
202020
202110
202310
202420
202520
202620
FIG. 1 — Lineage of K091976, 2009–2026Source: 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314
K231343Redemption Duo Hindfoot Nail SystemVilex, LLC20241
K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited20121
K100925Ascension Ankle Fusion Nail SystemAscension Orthopedics, Inc.20101
K141571Orthofix Ankle Hindfoot Nailing SystemOrthofix Srl20140
K102577Force Medical IM Nail SystemForce Medical, Inc.20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 12, 2018Class IIZ-1236-2018Device DesignCertain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.
Apr 1, 2016Class IIZ-1819-2016Equipment maintenanceInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K123810 (CarboFix Orthopedics, Ltd., 2013) has gone furthest, with 14 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. 2009, 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 Biomet Phoenix Ankle Nail System and the Biomet® Ankle Arthrodesis Nail are indicated for 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.…

Read the full statement (94 words)

The Biomet Phoenix Ankle Nail System and the Biomet® Ankle Arthrodesis Nail are indicated for 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.

More from Biomet Trauma

7 FDA decisions under this applicant name. See the company

  • K092078Optilock Periarticular PlatingBiomet Trauma · 2009
  • K082874Biodrive Cannulated Screw SystemBiomet Trauma · 2009
  • K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 20081 recall
  • K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008
  • K071325Biomet Variable Locking Plate SystemBiomet Trauma · 2007

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/K091976 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091976: Biomet Phoenix Ankle Nail and Ankle 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/K091976

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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