510(k) · Cleared
ClearedPiccolo Composite Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · HRS Plate, Fixation, Bone
Cleared on Nov 26, 2012 as substantially equivalent to K102597 (N.M.B. Medical Applications, Ltd., 2011) and 5 other predicates after a 291-day review. Its family tree reaches back 11 generations to 1984. 11 later devices descend from it.
- Decided
- Nov 26, 2012
- Review
- 291 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K841189 (1984). 125 ancestors in all, the oldest K791619 (1979). 11 later devices descend from it, 6 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 backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- This deviceK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
- Descendant · cites it directly · 10 of its ownK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK160002 Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK143496 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK170401 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
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 backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- This deviceK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013 · cites it directly10descendants
- K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd. · 2016 · cites it directly4descendants
- K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015 · cites it directly4descendants
- K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017 · cites it directly3descendants
- K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on3descendants
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 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| 0 (this device) | K120409 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2012 | — |
| +1 | K130061 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2013 | — |
| +1 | K160002 | Piccolo Composite (R) Distal Volar Radius Plate System | CarboFix Orthopedics, Ltd. | 2016 | — |
| +1 | K143496 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2015 | — |
| +1 | K170401 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2017 | — |
| +2 | 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 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 9 | 0 |
| 2003 | 12 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K102597 | Piccolo Composite Plate SystemSummary page 2…edics, Ltd. Piccolo CompositeTM Plate System - Distal Fibula & One-Third Tubular Predicate Devices * Piccolo CompositeTM Plate System (CarboFix Orthopedics Ltd.; K102597) * Synthes 2.7 mmI3.5 mm LCP Distal Fibula Plates (Synthes; K073460) N Synthes One Third Tubular LCP Plate (Synthes; KOI… | 2011 |
| * | K073460 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 2…ubular Predicate Devices * Piccolo CompositeTM Plate System (CarboFix Orthopedics Ltd.; K102597) * Synthes 2.7 mmI3.5 mm LCP Distal Fibula Plates (Synthes; K073460) N Synthes One Third Tubular LCP Plate (Synthes; KOI 1335) a VariAXM Distal Fibula Plate and Fibula Straight Plates (Stryk… | 2008 |
| * | K011335 | Synths One-Third Tubular DCL Plate | 2001 |
| * | K081284 | Variax Distal Fibula PlateSummary page 2…) N Synthes One Third Tubular LCP Plate (Synthes; KOI 1335) a VariAXM Distal Fibula Plate and Fibula Straight Plates (Stryker (Howmedica Osteonics Corp.); K081284) a SPS Small Fragment Set (Stryker (Howmedica Osteonics Corp.); K000636) N Mini Variable System (Orthoelix Surgical Design… | 2008 |
| * | K000636 | Stryker Trauma Plating SystemSummary page 2…Distal Fibula Plate and Fibula Straight Plates (Stryker (Howmedica Osteonics Corp.); K081284) a SPS Small Fragment Set (Stryker (Howmedica Osteonics Corp.); K000636) N Mini Variable System (Orthoelix Surgical Designs, Inc.; K I 1104 1) Indications for Use Piccolo Composite TmDistal Fibula… | 2000 |
| * | K111041 | Mini Variable System | 2011 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130061 | Piccolo Composite Plate System | 2013 | 10 |
| K160002 | Piccolo Composite (R) Distal Volar Radius Plate System | 2016 | 4 |
| K143496 | Piccolo Composite Plate System | 2015 | 4 |
| K170401 | Piccolo Composite® Plate System | 2017 | 3 |
| K182015 | Piccolo Composite® Plate System | 2018 | 1 |
| K201917 | Piccolo Composite Proximal Tibia Plate System | 2020 | 0 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 125 ancestors have a recall of any class.
- Of its descendants, K130061 (CarboFix Orthopedics, Ltd., 2013) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K102597.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
Piccolo Composite Distal Fibula Plate System The Piccolo Composite Distal Fibula Plates are indicated for fractures, osteotomnies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone. Piccolo Composite One-Third Tubular Plate System The Piccolo Composite One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and…
Read the full statement (121 words)
Piccolo Composite Distal Fibula Plate System
The Piccolo Composite Distal Fibula Plates are indicated for fractures, osteotomnies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.
Piccolo Composite One-Third Tubular Plate System
The Piccolo Composite One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.
Piccolo Composite Proximal Humerus Plate System
The Piccolo Composite Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
Piccolo Composite Distal Volar Radius Plate System
The Piccolo Composite Distal Volar Radius Plate is indicated for fractures and osteotomnies of the distal volar radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120409: Piccolo Composite Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120409
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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