510(k) · Cleared
ClearedPiccolo Composite Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N.M.B. Medical Applications, Ltd. · HRS Plate, Fixation, Bone
Cleared on Feb 24, 2011 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 7 other predicates after a 167-day review. Its family tree reaches back 10 generations to 1984. 15 later devices descend from it.
- Decided
- Feb 24, 2011
- Review
- 167 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 10 generations to K841189 (1984). 87 ancestors in all, the oldest K791619 (1979). 15 later devices descend from it, 8 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 2 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 1 generation backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- This deviceK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- Descendant · cites it directly · 11 of its ownK120409 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
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 4 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 3 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 2 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- 1 generation backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- This deviceK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012 · cites it directly11descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −4 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −3 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −2 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| −1 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| 0 (this device) | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| +1 | 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 | — |
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 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 1…CFR §888.3030; Class 11; Product Code HRS). Predicate Devices Intended Use/Designffechnolopv/Oneration * Synthes 4.5 mm Locking Compression Plate System (Synthes; K082807) " Synthes LCP Proximal Humerus Plate (Synthes; K01 1815) N.M.R. MEDICAL APPLICATIONS LTD..… | 2008 |
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 1…ces Intended Use/Designffechnolopv/Oneration * Synthes 4.5 mm Locking Compression Plate System (Synthes; K082807) " Synthes LCP Proximal Humerus Plate (Synthes; K01 1815) N.M.R. MEDICAL APPLICATIONS LTD.. PICCOLO COMPOSITE TM PLATE SYSTEM "… | 2001 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 2…=== N.M.R. MEDICAL APPLICATIONS LTD.. PICCOLO COMPOSITE TM PLATE SYSTEM " Synthes LCP Proximal Humerus Plate, Long (Synthes; K04 1860) " DVR Anatomic Plating System (DePuy Orthopaedics, Inc. (previously Hand Innovations, Inc.); e.g., K… | 2004 |
| * | K002775 | Distal Volar Radius Fracture Repair SystemSummary page 2…al Humerus Plate, Long (Synthes; K04 1860) " DVR Anatomic Plating System (DePuy Orthopaedics, Inc. (previously Hand Innovations, Inc.); e.g., K002775, K0903 74) The above mentioned predicate plates are manufactured from titanium, titanium alloy and/or stainless steel. Materia… | 2000 |
| * | K090374 | Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…Summary page 2…s Plate, Long (Synthes; K04 1860) " DVR Anatomic Plating System (DePuy Orthopaedics, Inc. (previously Hand Innovations, Inc.); e.g., K002775, K0903 74) The above mentioned predicate plates are manufactured from titanium, titanium alloy and/or stainless steel. Material *… | 2009 |
| * | K091425 | Quantum M Composite Nailing SystemSummary page 2…eel. Material * Piccolo Composite TMNailing System (formerly named Quantum IM Composite Nailing System) (N.M.B. Medical Applications Ltd.; K09 1425, K100497) " Fixion®'DHS System (N.M.B. Medical Applications Ltd.; K03 140 1) The material of the Piccolo Composite P… | 2010 |
| * | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System)Summary page 2…terial * Piccolo Composite TMNailing System (formerly named Quantum IM Composite Nailing System) (N.M.B. Medical Applications Ltd.; K09 1425, K100497) " Fixion®'DHS System (N.M.B. Medical Applications Ltd.; K03 140 1) The material of the Piccolo Composite Plate (CER… | 2010 |
| * | K031401 | Fixion Dynamic Hip Screw System (Fixion DHS)Summary page 2…um IM Composite Nailing System) (N.M.B. Medical Applications Ltd.; K09 1425, K100497) " Fixion®'DHS System (N.M.B. Medical Applications Ltd.; K03 140 1) The material of the Piccolo Composite Plate (CER-PEEK) was previously cleared for use in intramnedullary rods (K09 1425, K 1004… | 2003 |
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120409 | Piccolo Composite Plate System | 2012 | 11 |
| 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 |
| K160995 | NEOVIEW Plating System | 2016 | 2 |
| 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 27 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 14 of the 87 ancestors have a recall of any class.
- Of its descendants, K120409 (CarboFix Orthopedics, Ltd., 2012) has gone furthest, with 11 descendants of its own.
- 42 other devices also cite its predicate K082807.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
The Piccolo Composite Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
The Piccolo Composite Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102597: Piccolo Composite Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102597
Report an extraction error
Are you the manufacturer?
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