510(k) · Cleared
ClearedPiccolo Composite Ankle Arthrodesis Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 14, 2013 as substantially equivalent to K102369 (N.M.B. Medical Applications, Ltd., 2011) and 4 other predicates after a 185-day review. Its family tree reaches back 12 generations to 1984. 14 later devices descend from it.
- Decided
- Jun 14, 2013
- Review
- 185 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K841189 (1984). 87 ancestors in all, the oldest K791619 (1979). 14 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 2 generations backK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- 1 generation backK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- This deviceK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- Descendant · cites it directly · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
- Descendant · 2 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK201227 Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 5 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 4 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 3 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 2 generations backK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- 1 generation backK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- This deviceK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · cites it directly8descendants
- K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 2 generations on6descendants
- K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on6descendants
- K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2020 · 3 generations on5descendants
- K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −5 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −4 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −3 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −2 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| −1 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
| 0 (this device) | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| +1 | K182307 | Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary… | Paragon 28, Inc. | 2019 | — |
| +2 | K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | 2020 | — |
| +2 | K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 | — |
| +3 | K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 | — |
| +1 | K132774 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K102369 | Piccolo Composite Nailing SystemSummary page 1…Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices * Piccolo Composite Nailing System — Tibia and Femur (CarboFix Orthopedics Ltd.; K102369, K111056) Page 10of 3 K123810 CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System — Ankle Arthrodesis… | 2011 |
| * | K111056 | Piccolo Composite Nailing SystemSummary page 1…ullary and Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices * Piccolo Composite Nailing System — Tibia and Femur (CarboFix Orthopedics Ltd.; K102369, K111056) Page 10of 3 K123810 CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System — Ankle Arthrodesis * Phoeni… | 2011 |
| * | K081243 | Biomet Phoenix Ankle Nail SystemSummary page 2…f 3 K123810 CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System — Ankle Arthrodesis * Phoenix Ankle Arthrodesis Nailing System (Biomet Trauma; K081243, K091976) = Valor® Ankle Fusion Nail System (Wright Medical Technology, Inc.; KO90857) Intended Use/Indications for Use Piccolo… | 2008 |
| * | K091976 | Biomet Phoenix Ankle Nail and Ankle Arthrodesis NailSummary page 2…Page 2 === K123810 CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System — Ankle Arthrodesis * Phoenix Ankle Arthrodesis Nailing System (Biomet Trauma; K081243, K091976) = Valor® Ankle Fusion Nail System (Wright Medical Technology, Inc.; KO90857) Intended Use/Indications for Use Piccolo Composit… | 2009 |
| * | K090857 | Valor Ankle Fusion Nail System | 2009 |
What descends from it? (14)
See all 144 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 29 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 25 of the 87 ancestors have a recall of any class.
- Of its descendants, K182307 (Paragon 28, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K102369.
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. 2013, 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 Piccolo Composite Ankle Arthrodesis Nails are indicated for tibiotalocalcaneal arthrodesis (fusion).
Specific indications include:
Avascular necrosis of the talus
Failed total ankle arthroplasty
Trauma (malunited tibial pilon fracture)
Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
Revision ankle arthrodesis
Neuroarthropathy
Rheumatoid arthritis
Osteoarthritis
Pseudoarthrosis
Post-traumatic arthrosis
Previously infected arthrosis
Charcot foot
Severe endstage degenerative arthritis
Severe defects after tumor resection
Pantalar arthrodesis
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/K123810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123810: Piccolo Composite Ankle Arthrodesis Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123810
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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