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 May 12, 2017 as substantially equivalent to K102597 (N.M.B. Medical Applications, Ltd., 2011) and 7 other predicates after a 92-day review. Its family tree reaches back 14 generations to 1984. 3 later devices descend from it.
- Decided
- May 12, 2017
- Review
- 92 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 14 generations to K841189 (1984). 169 ancestors in all, the oldest K791619 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
- 2 generations backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- 1 generation backK143496 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015
- This deviceK170401 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK182015 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · cites it directly · 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 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 7 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 6 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 5 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- 4 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- 3 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
- 2 generations backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
- 1 generation backK143496 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2015
- This deviceK170401 Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd. · 2018 · cites it directly1descendant
- K213698CoLink PCR Plating SystemIn2bones USA, LLC · 2022 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −7 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −6 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −5 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −4 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| −3 | K120409 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2012 | — |
| −2 | K130061 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2013 | — |
| −1 | K143496 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2015 | — |
| 0 (this device) | K170401 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2017 | — |
| +1 | K182015 | Piccolo Composite® Plate System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +1 | 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 | 2 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 15 | 0 |
| 2001 | 18 | 0 |
| 2002 | 10 | 0 |
| 2003 | 12 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (8)
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 5…3 CarboFix Orthopedics, Ltd. Piccolo Composite® Plate System — MTP Predicate Devices Primary Predicate: * Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, 143496, 160002) Additional Predicates: * 24mm/2.7mm Variable Angle LCP Forefoot/Midfoot System — First MTP Fu… | 2011 |
| * | K120409 | Piccolo Composite Plate SystemSummary page 5…Fix Orthopedics, Ltd. Piccolo Composite® Plate System — MTP Predicate Devices Primary Predicate: * Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, 143496, 160002) Additional Predicates: * 24mm/2.7mm Variable Angle LCP Forefoot/Midfoot System — First MTP Fusion (Syn… | 2012 |
| * | K130061 | Piccolo Composite Plate SystemSummary page 5…pedics, Ltd. Piccolo Composite® Plate System — MTP Predicate Devices Primary Predicate: * Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, 143496, 160002) Additional Predicates: * 24mm/2.7mm Variable Angle LCP Forefoot/Midfoot System — First MTP Fusion (Synthes; K10… | 2013 |
| * | K143496 | Piccolo Composite Plate SystemSummary page 5…td. Piccolo Composite® Plate System — MTP Predicate Devices Primary Predicate: * Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, 143496, 160002) Additional Predicates: * 24mm/2.7mm Variable Angle LCP Forefoot/Midfoot System — First MTP Fusion (Synthes; K100776) =… | 2015 |
| * | K160002 | Piccolo Composite (R) Distal Volar Radius Plate SystemSummary page 5…olo Composite® Plate System — MTP Predicate Devices Primary Predicate: * Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, 143496, 160002) Additional Predicates: * 24mm/2.7mm Variable Angle LCP Forefoot/Midfoot System — First MTP Fusion (Synthes; K100776) = MaxLock… | 2016 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 5…Orthopedics Ltd.; K102597, K120409, K130061, 143496, 160002) Additional Predicates: * 24mm/2.7mm Variable Angle LCP Forefoot/Midfoot System — First MTP Fusion (Synthes; K100776) = MaxLock Extreme MTP Plate Systems (Tornier (OrthoHelix Surgical Designs Inc.); K101962, K100618, and more) Indications for Us… | 2010 |
| * | K101962 | Mini Maxlock Extreme Plating SystemSummary page 5…m/2.7mm Variable Angle LCP Forefoot/Midfoot System — First MTP Fusion (Synthes; K100776) = MaxLock Extreme MTP Plate Systems (Tornier (OrthoHelix Surgical Designs Inc.); K101962, K100618, and more) Indications for Use The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies,… | 2010 |
| * | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle TechnologySummary page 5…ariable Angle LCP Forefoot/Midfoot System — First MTP Fusion (Synthes; K100776) = MaxLock Extreme MTP Plate Systems (Tornier (OrthoHelix Surgical Designs Inc.); K101962, K100618, and more) Indications for Use The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions,… | 2010 |
What descends from it? (3)
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 33 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 36 of the 169 ancestors have a recall of any class.
- Of its descendants, K182015 (CarboFix Orthopedics, Ltd., 2018) has gone furthest, with 1 descendant 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. 2017, 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 foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.
The MTP plates are indicated for treatment of deformations, fractures, nonunions and replantations of the 1st metatarso-phalangeal joint and 1st metatarsal bone.
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/K170401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170401: 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/K170401
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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