510(k) · Cleared
ClearedPiccolo Composite Proximal Tibia 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 Oct 8, 2020 as substantially equivalent to K120689 (Synthes (USA) Products, LLC, 2012) and 8 other predicates after a 90-day review. Its family tree reaches back 16 generations to 1984.
- Decided
- Oct 8, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 16 generations to K841189 (1984). 218 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 backK143496 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015
- 2 generations backK170401 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017
- 1 generation backK182015 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018
- This deviceK201917 Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd. · 2020
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 backK143496 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015
- 2 generations backK170401 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017
- 1 generation backK182015 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018
- This deviceK201917 Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd. · 2020
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 | K143496 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2015 | — |
| −2 | K170401 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2017 | — |
| −1 | K182015 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2018 | — |
| 0 (this device) | 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 | 2 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 19 | 0 |
| 2001 | 19 | 0 |
| 2002 | 10 | 0 |
| 2003 | 15 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 12 | 0 |
| 2009 | 12 | 0 |
| 2010 | 10 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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? (9)
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 |
|---|---|---|---|
| * | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSummary page 5…Ltd. Piccolo Composite® Plate System – Proximal Tibia Predicate Devices Primary 3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc.; K120689) Additional 3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc.; K030597, K032269, K050646, and m… | 2012 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 5…VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc.; K120689) Additional 3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc.; K030597, K032269, K050646, and more) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate Sys… | 2003 |
| * | K032269 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 5…oximal Tibia Plate System (DePuy Synthes, Inc.; K120689) Additional 3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc.; K030597, K032269, K050646, and more) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate System (Carb… | 2003 |
| * | K050646 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 5…bia Plate System (DePuy Synthes, Inc.; K120689) Additional 3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc.; K030597, K032269, K050646, and more) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate System (CarboFix Orth… | 2005 |
| * | K090877 | Proximal Tibia Locking Plate Standard and Large, 3.5MM Low Profile and Multidirectional…Summary page 5…3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc.; K030597, K032269, K050646, and more) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, K182015, and more) Indic… | 2009 |
| * | K102597 | Piccolo Composite Plate SystemSummary page 5…K030597, K032269, K050646, and more) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, K182015, and more) Indications for Use The Piccolo Composite Proximal Tibia Plate System is intended… | 2011 |
| * | K120409 | Piccolo Composite Plate SystemSummary page 5…K032269, K050646, and more) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, K182015, and more) Indications for Use The Piccolo Composite Proximal Tibia Plate System is intended to treat… | 2012 |
| * | K130061 | Piccolo Composite Plate SystemSummary page 5…, and more) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, K182015, and more) Indications for Use The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the… | 2013 |
| * | K182015 | Piccolo Composite® Plate SystemSummary page 5…e) A.L.P.S Proximal Tibial Plating System (Biomet; K090877) Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, K182015, and more) Indications for Use The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal… | 2018 |
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 36 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 47 of the 218 ancestors have a recall of any class.
- 7 other devices also cite its predicate K120689.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused. For Lateral Plates — non-unions, malunions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. For Medial Plates — intended to buttress…
Read the full statement (121 words)
The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
For Lateral Plates — non-unions, malunions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
For Medial Plates — intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
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/K201917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201917: Piccolo Composite Proximal Tibia 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/K201917
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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