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 Jan 6, 2016 as substantially equivalent to K151010 (CarboFix Orthopedics, Ltd., 2015) and 3 other predicates after a 27-day review. Its family tree reaches back 15 generations to 1984. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 6, 2016
- Review
- 27 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 15 generations to K841189 (1984). 158 ancestors in all, the oldest K791619 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- 2 generations backK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- 1 generation backK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · Recalled
- This deviceK153536 Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK173652 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 8 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 7 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 6 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 5 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 4 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
- 3 generations backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- 2 generations backK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- 1 generation backK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · Recalled
- This deviceK153536 Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −8 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −7 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −6 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −5 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| −4 | K120409 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2012 | — |
| −3 | K130061 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2013 | — |
| −2 | K132774 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| −1 | K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2015 | 1 |
| 0 (this device) | K153536 | Piccolo Composite® Nailing System | CarboFix Orthopedics, Ltd. | 2016 | — |
| +1 | K173652 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2017 | — |
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 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 10 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 13 | 0 |
| 2001 | 18 | 0 |
| 2002 | 10 | 0 |
| 2003 | 13 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K151010 | Piccolo Composite Nailing SystemSummary page 5…of 3 CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System – Proximal Femur Predicate Devices ƒ Piccolo Composite® Nailing System (CarboFix Orthopedics Ltd.; K151010, K102369, K111056) ƒ Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more) Intended Use/I… | 2015 |
| * | K102369 | Piccolo Composite Nailing SystemSummary page 5…Orthopedics Ltd. Piccolo Composite® Nailing System – Proximal Femur Predicate Devices ƒ Piccolo Composite® Nailing System (CarboFix Orthopedics Ltd.; K151010, K102369, K111056) ƒ Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more) Intended Use/Indications for… | 2011 |
| * | K111056 | Piccolo Composite Nailing SystemSummary page 5…cs Ltd. Piccolo Composite® Nailing System – Proximal Femur Predicate Devices ƒ Piccolo Composite® Nailing System (CarboFix Orthopedics Ltd.; K151010, K102369, K111056) ƒ Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more) Intended Use/Indications for Use Picco… | 2011 |
| * | K043431 | GAMMA3 Nail SystemSummary page 5…ices ƒ Piccolo Composite® Nailing System (CarboFix Orthopedics Ltd.; K151010, K102369, K111056) ƒ Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more) Intended Use/Indications for Use Piccolo Composite Proximal Femur Nails The Piccolo Composite Proximal Femur Na… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173652 | Piccolo Composite Nailing System | 2017 | 0 |
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 32 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 43 of the 158 ancestors have a recall of any class.
- Of its descendants, K173652 (CarboFix Orthopedics, Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151010.
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. 2016, 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?
Piccolo Composite Proximal Femur Nails
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153536: 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/K153536
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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