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 Oct 3, 2013 as substantially equivalent to K091425 (N.M.B. Medical Applications, Ltd., 2010) and 5 other predicates after a 28-day review. Its family tree reaches back 13 generations to 1984. 3 later devices descend from it.
- Decided
- Oct 3, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K841189 (1984). 151 ancestors in all, the oldest K791619 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 2 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
- 1 generation backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- This deviceK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK153536 Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK173652 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 6 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 5 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 4 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 3 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 2 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
- 1 generation backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- This deviceK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015 · cites it directly2descendants
- K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · 2 generations on1descendant
- K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −6 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −5 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −4 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −3 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| −2 | K120409 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2012 | — |
| −1 | K130061 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2013 | — |
| 0 (this device) | K132774 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| +1 | K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2015 | 1 |
| +2 | K153536 | Piccolo Composite® Nailing System | CarboFix Orthopedics, Ltd. | 2016 | 1 |
| +2 | 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 | 16 | 0 |
| 2002 | 10 | 0 |
| 2003 | 12 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (6)
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 2…KI132774 CarboFix Orthopedics Ltd. Piccolo Composit' Nailing System Predicate Devices " Piccolo Composit" Nailing Systems (CarboFix Orthopedics Ltd.; K09 1425, K100497, K102369, KI 11056, K123810) * Piccolo Composit&c' Plate Systems (CarboFix Orthopedics Ltd.; K130061. and… | 2010 |
| * | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System)Summary page 2…x Orthopedics Ltd. Piccolo Composit' Nailing System Predicate Devices " Piccolo Composit" Nailing Systems (CarboFix Orthopedics Ltd.; K09 1425, K100497, K102369, KI 11056, K123810) * Piccolo Composit&c' Plate Systems (CarboFix Orthopedics Ltd.; K130061. and more) Inten… | 2010 |
| * | K102369 | Piccolo Composite Nailing SystemSummary page 2…dics Ltd. Piccolo Composit' Nailing System Predicate Devices " Piccolo Composit" Nailing Systems (CarboFix Orthopedics Ltd.; K09 1425, K100497, K102369, KI 11056, K123810) * Piccolo Composit&c' Plate Systems (CarboFix Orthopedics Ltd.; K130061. and more) Intended Use/i… | 2011 |
| * | K111056 | Piccolo Composite Nailing System | 2011 |
| * | K123810 | Piccolo Composite Ankle Arthrodesis Nailing SystemSummary page 2…omposit' Nailing System Predicate Devices " Piccolo Composit" Nailing Systems (CarboFix Orthopedics Ltd.; K09 1425, K100497, K102369, KI 11056, K123810) * Piccolo Composit&c' Plate Systems (CarboFix Orthopedics Ltd.; K130061. and more) Intended Use/indications for Use… | 2013 |
| * | K130061 | Piccolo Composite Plate SystemSummary page 2…ling Systems (CarboFix Orthopedics Ltd.; K09 1425, K100497, K102369, KI 11056, K123810) * Piccolo Composit&c' Plate Systems (CarboFix Orthopedics Ltd.; K130061. and more) Intended Use/indications for Use Piccolo Conmposite Humeral. Proximal Humerus. Tibial and Femoral Nails Indica… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151010 | Piccolo Composite Nailing System | 2015 | 2 |
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 9 months on median.
- 38 of the 151 ancestors have a recall of any class.
- Of its descendants, K151010 (CarboFix Orthopedics, Ltd., 2015) has gone furthest, with 2 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. 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?
Piccolo Composite Humeral. Proximal Humerus. Tibial and Femoral Nails Indications 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 nails are indicated for fixation of fractures that occur in and between the proximal and distal third of…
Read the full statement (135 words)
Piccolo Composite Humeral. Proximal Humerus. Tibial and Femoral Nails
Indications 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 nails are indicated for fixation of fractures that occur in and
between the proximal and distal third of the long bones being treated.
Piccolo Composite Ankle Arthrodesis Nails
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
artbrosis; Previously infected arthrosis; Charcot foot; Severe endstage degenerative
arthritis; Severe defects after tumor resection; Pantalar arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132774: 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/K132774
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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