510(k) · Cleared
ClearedBiomet Phoenix Ankle Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Trauma · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 27, 2008 as substantially equivalent to K070955 (Biomet Orthopedics, Inc., 2007) and 3 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1998. 18 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K982953 (1998). 5 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
- 1 generation backK021786 Titanium Ankle Arthrodesis NailBiomet, Inc. · 2002 · Recalled
- This deviceK081243 Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008
- Descendant · cites it directly · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- Descendant · 2 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- Descendant · 3 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
- Descendant · 3 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- Descendant · 4 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · 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
| 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) | K081243 | Biomet Phoenix Ankle Nail System | Biomet Trauma | 2008 | — |
| +1 | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| +2 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
| +3 | K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020 | — |
| +3 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| +4 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K070955 | Acid Etched Lag ScrewsSummary page 1…Rod, Fixation, Intramedullary and Accessories (21 CFR 888.3020) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Acid Etched Lag Screws K070955 Biomet Trauma Tibial Locking Nail System K063570 Biomet Trauma Ankle Arthrodesis Nail… | 2007 |
| * | K063570 | Biomet Tibial Locking Nail SystemSummary page 1…y Marketed Devices To Which Substantial Equivalence Is Claimed: Acid Etched Lag Screws K070955 Biomet Trauma Tibial Locking Nail System K063570 Biomet Trauma Ankle Arthrodesis Nail K021786 Biomet, Inc. UltiMax Ankle Fusion Rod… | 2007 |
| * | K021786 | Titanium Ankle Arthrodesis NailSummary page 1…ched Lag Screws K070955 Biomet Trauma Tibial Locking Nail System K063570 Biomet Trauma Ankle Arthrodesis Nail K021786 Biomet, Inc. UltiMax Ankle Fusion Rod K991790 Encore Orthopedics, Inc. Device Description:… | 2002 |
| * | K991790 | Ultimax Ankle Fusion Rod SystemSummary page 1…Locking Nail System K063570 Biomet Trauma Ankle Arthrodesis Nail K021786 Biomet, Inc. UltiMax Ankle Fusion Rod K991790 Encore Orthopedics, Inc. Device Description: The Biomet PhoeniXTm Nail System isan intramedullary nail system comp… | 1999 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K123810 (CarboFix Orthopedics, Ltd., 2013) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K070955.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 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 Biomet Phoenix TM Ankle Nail System is 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081243: Biomet Phoenix Ankle Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081243
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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