510(k) · Cleared
Recalled · Class II · 2016Piccolo Composite 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 May 3, 2011 as substantially equivalent to K091425 (N.M.B. Medical Applications, Ltd., 2010) and 11 other predicates after a 15-day review. Its family tree reaches back 11 generations to 1984. 15 later devices descend from it. It has been recalled once.
- Decided
- May 3, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 12
Its longest line of descent runs back 11 generations to K841189 (1984). 78 ancestors in all, the oldest K791619 (1979). 15 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 2 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 1 generation backK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- This deviceK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011
- 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
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 4 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 3 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 2 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 1 generation backK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- This deviceK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · 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 |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −4 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −3 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −2 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −1 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| 0 (this device) | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | — |
| +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 |
|---|---|---|
| 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 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 11 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 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? (12)
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 |
|---|---|---|---|
| * | K091425 | Quantum M Composite Nailing SystemSummary page 1…Fixation, Jntramedullary and. Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices * Piccolo CompositeTM Nailing System (CarboFix Orthopedics Ltd.); K091425, K 100497, K1023 69) * T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more) CarboFix… | 2010 |
| * | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System)Summary page 1…amedullary and. Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices * Piccolo CompositeTM Nailing System (CarboFix Orthopedics Ltd.); K091425, K 100497, K1023 69) * T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more) CarboFix Orthopedics Ltd.… | 2010 |
| * | K102369 | Piccolo Composite Nailing SystemSummary page 1…and. Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices * Piccolo CompositeTM Nailing System (CarboFix Orthopedics Ltd.); K091425, K 100497, K1023 69) * T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more) CarboFix Orthopedics Ltd. Piccolo C… | 2011 |
| * | K003018 | Titan Tibial NailSummary page 1…vices * Piccolo CompositeTM Nailing System (CarboFix Orthopedics Ltd.); K091425, K 100497, K1023 69) * T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more) CarboFix Orthopedics Ltd. Piccolo CompositeTm Nailing System - Tibia &Femur M T2 Femoral Nail (Stryker… | 2000 |
| * | K010801 | T2 Femoral Nail | 2001 |
| * | K914453 | Universal Tibial Nail and Unreamed Tibial NailSummary page 2…iling System - Tibia &Femur M T2 Femoral Nail (Stryker (Howmedica Osteonics Corp.); KOlO0801 and more) * UTN Solid Tibial Nail/CTN Cannulated Tibial Nail (Synthes; K914453, K962047) * Expert R/AFN Retrograde/Antegrade Femoral Nail (Synthes; K033618) * Fixion® Interlocking Intramedullary Nai… | 1992 |
| * | K962047 | Titanium Cannulated Tibial Nail (TI CTN)Summary page 2…tem - Tibia &Femur M T2 Femoral Nail (Stryker (Howmedica Osteonics Corp.); KOlO0801 and more) * UTN Solid Tibial Nail/CTN Cannulated Tibial Nail (Synthes; K914453, K962047) * Expert R/AFN Retrograde/Antegrade Femoral Nail (Synthes; K033618) * Fixion® Interlocking Intramedullary Nailing Syst… | 1996 |
| * | K033618 | Synthes (Usa) Retrograde/Antegrade Femoral Nail SystemSummary page 2…); KOlO0801 and more) * UTN Solid Tibial Nail/CTN Cannulated Tibial Nail (Synthes; K914453, K962047) * Expert R/AFN Retrograde/Antegrade Femoral Nail (Synthes; K033618) * Fixion® Interlocking Intramedullary Nailing System (CarboFix Orthopedics Ltd.); K002783, K013449, K032588) *… | 2004 |
| * | K002783 | Fixion Interlocking Nail (Fixion IL Nail)Summary page 2…7) * Expert R/AFN Retrograde/Antegrade Femoral Nail (Synthes; K033618) * Fixion® Interlocking Intramedullary Nailing System (CarboFix Orthopedics Ltd.); K002783, K013449, K032588) * M/DN® Intramedullary Fixation System (Zimmer; K965098) Intended Usc/indications for Use Piccolo Compo… | 2000 |
| * | K013449 | Modification to Fixion Interlocking Intramedullary Nailing SystemSummary page 2…Expert R/AFN Retrograde/Antegrade Femoral Nail (Synthes; K033618) * Fixion® Interlocking Intramedullary Nailing System (CarboFix Orthopedics Ltd.); K002783, K013449, K032588) * M/DN® Intramedullary Fixation System (Zimmer; K965098) Intended Usc/indications for Use Piccolo Composite Tibi… | 2001 |
| * | K032588 | Modification to Fixion Intramedullary Nailing System (Fixion IM)Summary page 2…/AFN Retrograde/Antegrade Femoral Nail (Synthes; K033618) * Fixion® Interlocking Intramedullary Nailing System (CarboFix Orthopedics Ltd.); K002783, K013449, K032588) * M/DN® Intramedullary Fixation System (Zimmer; K965098) Intended Usc/indications for Use Piccolo Composite Tibial and Fe… | 2003 |
| * | K965098 | Intramedullary Nail SystemSummary page 2…Fixion® Interlocking Intramedullary Nailing System (CarboFix Orthopedics Ltd.); K002783, K013449, K032588) * M/DN® Intramedullary Fixation System (Zimmer; K965098) Intended Usc/indications for Use Piccolo Composite Tibial and Femoral Nails Indications for the Piccolo Composite Tibial and F… | 1997 |
What descends from it? (15)
See all 154 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2016 | Class II | Z-1991-2016 | Other | Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 19 of the 78 ancestors have a recall of any class.
- Of its descendants, K123810 (CarboFix Orthopedics, Ltd., 2013) has gone furthest, with 14 descendants of its own.
- 6 other devices also cite its predicate K091425.
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. 2011, 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?
Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111056: Piccolo Composite 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/K111056
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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