510(k) · Cleared
ClearedPiccolo 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 Dec 28, 2017 as substantially equivalent to K153536 (CarboFix Orthopedics, Ltd., 2016) and 2 other predicates after a 30-day review. Its family tree reaches back 16 generations to 1984.
- Decided
- Dec 28, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 159 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- 2 generations backK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · Recalled
- 1 generation backK153536 Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · Recalled
- This deviceK173652 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 9 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 8 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 7 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 6 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 5 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
- 4 generations backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- 3 generations backK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- 2 generations backK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · Recalled
- 1 generation backK153536 Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · Recalled
- This deviceK173652 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −9 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −8 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −7 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −6 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| −5 | K120409 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2012 | — |
| −4 | K130061 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2013 | — |
| −3 | K132774 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| −2 | K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2015 | 1 |
| −1 | K153536 | Piccolo Composite® Nailing System | CarboFix Orthopedics, Ltd. | 2016 | 1 |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K153536 | Piccolo Composite® Nailing SystemSummary page 5…iccolo Composite® Nailing System — Proximal Femur Predicate Devices Primary Predicate: * Piccolo Composite® Proximal Femur Nailing System (CarboFix Orthopedics Ltd.; K153536,K151010) Additional Predicate: » Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more) Intended Use/Indi… | 2016 |
| * | K151010 | Piccolo Composite Nailing SystemSummary page 5…omposite® Nailing System — Proximal Femur Predicate Devices Primary Predicate: * Piccolo Composite® Proximal Femur Nailing System (CarboFix Orthopedics Ltd.; K153536,K151010) Additional Predicate: » Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more) Intended Use/Indications… | 2015 |
| * | K043431 | GAMMA3 Nail SystemSummary page 5…Composite® Proximal Femur Nailing System (CarboFix Orthopedics Ltd.; K153536,K151010) Additional Predicate: » Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more) Intended Use/Indications for Use The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stabl… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 44 of the 159 ancestors have a recall of any class.
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. 2017, 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173652: 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/K173652
Report an extraction error
Are you the manufacturer?
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