510(k) · Cleared
ClearedPiccolo Composite (R) Distal Volar Radius 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 Mar 9, 2016 as substantially equivalent to K102597 (N.M.B. Medical Applications, Ltd., 2011) and 3 other predicates after a 65-day review. Its family tree reaches back 13 generations to 1984. 4 later devices descend from it.
- Decided
- Mar 9, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K841189 (1984). 128 ancestors in all, the oldest K791619 (1979). 4 later devices descend from it, 2 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 deviceK160002 Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK170401 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK182015 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK213698 CoLink PCR Plating SystemIn2bones USA, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK201917 Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd. · 2020
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 deviceK160002 Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017 · cites it directly3descendants
- K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018 · cites it directly1descendant
- K213698CoLink PCR Plating SystemIn2bones USA, LLC · 2022 · 2 generations on0descendants
- K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd. · 2020 · 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) | K160002 | Piccolo Composite (R) Distal Volar Radius Plate System | CarboFix Orthopedics, Ltd. | 2016 | — |
| +1 | K170401 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2017 | — |
| +1 | K182015 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +2 | K213698 | CoLink PCR Plating System | In2bones USA, LLC | 2022 | — |
| +2 | K201917 | Piccolo Composite Proximal Tibia Plate System | CarboFix Orthopedics, Ltd. | 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 | 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 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (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 |
|---|---|---|---|
| * | K102597 | Piccolo Composite Plate SystemSummary page 4…bone fixation appliances and accessories (21 CFR §888.3030; Product Code HRS, KTT) Predicate Devices ƒ Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061) K160002 Page 2 of 2 CarboFix Orthopedics Ltd.… | 2011 |
| * | K120409 | Piccolo Composite Plate SystemSummary page 4…ation appliances and accessories (21 CFR §888.3030; Product Code HRS, KTT) Predicate Devices ƒ Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061) K160002 Page 2 of 2 CarboFix Orthopedics Ltd. Piccolo C… | 2012 |
| * | K130061 | Piccolo Composite Plate SystemSummary page 4…s and accessories (21 CFR §888.3030; Product Code HRS, KTT) Predicate Devices ƒ Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061) K160002 Page 2 of 2 CarboFix Orthopedics Ltd. Piccolo Composite® Dista… | 2013 |
| * | K083694 | Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius PlatesSummary page 5…ge 2 of 2 CarboFix Orthopedics Ltd. Piccolo Composite® Distal Volar Radius Plate System ƒ Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate (Synthes; K083694) Intended Use/Indications for Use The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteoto… | 2009 |
What descends from it? (4)
2 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)
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 32 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 128 ancestors have a recall of any class.
- Of its descendants, K170401 (CarboFix Orthopedics, Ltd., 2017) has gone furthest, with 3 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. 2016, 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?
The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160002: Piccolo Composite (R) Distal Volar Radius 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/K160002
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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