510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Piccolo Composite Nailing System

K151010510(k) TraditionalCleared Jul 28, 2015104-day reviewClass II21 CFR 888.3020Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

CarboFix Orthopedics, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jul 28, 2015 as substantially equivalent to K091425 (N.M.B. Medical Applications, Ltd., 2010) and 9 other predicates after a 104-day review. Its family tree reaches back 14 generations to 1984. 2 later devices descend from it. It has been recalled once.

Decided
Jul 28, 2015
Review
104 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
10

Its longest line of descent runs back 14 generations to K841189 (1984). 157 ancestors in all, the oldest K791619 (1979). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2011: 3 other ancestors2005: 5 other ancestors2001: 18 other ancestors2009: 4 other ancestors2008: 8 other ancestors2006: 4 other ancestors2004: 8 other ancestors2003: 13 other ancestors2002: 10 other ancestors2000: 13 other ancestors1998: 7 other ancestors1997: 6 other ancestors1996: 10 other ancestors1994: 4 other ancestors1993: 3 other ancestors1992: 4 other ancestors2007: 2 other ancestors1999: 8 other ancestors1995: 2 other ancestors1990: 2 other ancestors1989: 1 other ancestor1986: 1 other ancestor1981: 1 other ancestor1979: 1 other ancestor2010: 3 other ancestors1991: 1 other ancestor2016: 1 descendant cleared2017: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K043316 (2005) K052533 · Kimba Spinal Implant · Signus Medizintechnik GmbH · 2005×2: 2 generations cleared close together, K091425 (2010), K100497 (2010) K102597 · Piccolo Composite Plate System · N.M.B. Medical Applications, Ltd. · 2011×2: 2 generations cleared close together, K120409 (2012), K130061 (2013) K132774 · Piccolo Composite Nailing System · CarboFix Orthopedics, Ltd. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 27 other ancestors3 generations back: 28 other ancestors4 generations back: 30 other ancestors5 generations back: 13 other ancestors6 generations back: 10 other ancestors7 generations back: 4 other ancestors8 generations back: 4 other ancestors9 generations back: 7 other ancestors10 generations back: 8 other ancestors11 generations back: 4 other ancestors12 generations back: 1 other ancestor 1 generation forward: 2 descendants K132774 · Piccolo Composite Nailing System · CarboFix Orthopedics, Ltd. · 2013K130061 · Piccolo Composite Plate System · CarboFix Orthopedics, Ltd. · 2013K120409 · Piccolo Composite Plate System · CarboFix Orthopedics, Ltd. · 2012K102597 · Piccolo Composite Plate System · N.M.B. Medical Applications, Ltd. · 2011K100497 · Quantum IM Composite Nailing System (Quantum Nailing System) · N.M.B. Medical Applications, Ltd. · 2010K091425 · Quantum M Composite Nailing System · N.M.B. Medical Applications, Ltd. · 2010K052533 · Kimba Spinal Implant · Signus Medizintechnik GmbH · 2005K043316 · Rabea Spinal Implant · Signus Medizintechnik GmbH · 2005K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations between
  3. 3 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
  4. 2 generations backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
  5. 1 generation backK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  6. This deviceK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015
  7. Descendant · cites it directly · 1 of its ownK153536 Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · Recalled
  8. Descendant · cites it directly · 0 of its ownK173652 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017
Show all 14 generations
  1. Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 8 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
  8. 7 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
  9. 6 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
  10. 5 generations backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  11. 4 generations backK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
  12. 3 generations backK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
  13. 2 generations backK130061 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2013
  14. 1 generation backK132774 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  15. This deviceK151010 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd. · 2016 · cites it directly1descendant
  • K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−13K990148Stackable Cage SystemDepuy Motech Acromed1999—
−12K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−11K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−10K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−9K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−8K043316Rabea Spinal ImplantSignus Medizintechnik GmbH2005—
−7K052533Kimba Spinal ImplantSignus Medizintechnik GmbH2005—
−6K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.2010—
−5K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.2010—
−4K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.2011—
−3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.2012—
−2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.2013—
−1K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2013—
0 (this device)K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2015—
+1K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.20161
+1K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198110
198610
198910
199020
199110
199240
199330
199440
199520
1996100
199760
199870
199980
2000130
2001180
2002100
2003130
200480
200550
200640
200720
200880
200940
201030
201130
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
FIG. 1 — Lineage of K151010, 1984–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K091425Quantum M Composite Nailing System
Summary page 4
…Rod, Fixation, Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices ƒ Piccolo Composite Nailing System (CarboFix Orthopedics Ltd.; K091425, K100497, K102369, K111056, K123810, K132774);…
N.M.B. Medical Applications, Ltd.2010—
*K100497Quantum IM Composite Nailing System (Quantum Nailing System)
Summary page 4
…Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices ƒ Piccolo Composite Nailing System (CarboFix Orthopedics Ltd.; K091425, K100497, K102369, K111056, K123810, K132774);…
N.M.B. Medical Applications, Ltd.2010—
*K102369Piccolo Composite Nailing System
Summary page 4
…llary and Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices ƒ Piccolo Composite Nailing System (CarboFix Orthopedics Ltd.; K091425, K100497, K102369, K111056, K123810, K132774); K15101…
N.M.B. Medical Applications, Ltd.20111
*K111056Piccolo Composite Nailing System
Summary page 4
…Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices ƒ Piccolo Composite Nailing System (CarboFix Orthopedics Ltd.; K091425, K100497, K102369, K111056, K123810, K132774); K151010 page 2…
CarboFix Orthopedics, Ltd.20111
*K123810Piccolo Composite Ankle Arthrodesis Nailing System
Summary page 4
…ies (21 CFR §888.3020; Product Code HSB) Predicate Devices ƒ Piccolo Composite Nailing System (CarboFix Orthopedics Ltd.; K091425, K100497, K102369, K111056, K123810, K132774); K151010 page 2 of 3 Ca…
CarboFix Orthopedics, Ltd.2013—
*K132774Piccolo Composite Nailing System
Summary page 4
…FR §888.3020; Product Code HSB) Predicate Devices ƒ Piccolo Composite Nailing System (CarboFix Orthopedics Ltd.; K091425, K100497, K102369, K111056, K123810, K132774); K151010 page 2 of 3 CarboFix Or…
CarboFix Orthopedics, Ltd.2013—
*K043431GAMMA3 Nail System
Summary page 5
…K151010 page 2 of 3 CarboFix Orthopedics, Ltd. Piccolo Composite® Nailing System – Proximal Femur ƒ Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more); ƒ Trochanteric Fixation Nail (TFN) (Synthes; K011857 and more). ƒ Fixion® Interlocking Proximal Femur In…
Howmedica Osteonics Corp.2005—
*K011857Synthes (Usa) Trochanteric Fixation Nail (TFN) System
Summary page 5
…ailing System – Proximal Femur ƒ Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more); ƒ Trochanteric Fixation Nail (TFN) (Synthes; K011857 and more). ƒ Fixion® Interlocking Proximal Femur Intramedullary Nailing System (CarboFix; K010988, K012967 and more).…
Synthes (Usa)20017
*K010988Fixion Interlocking Proximal Femoral Nailing System
Summary page 5
…more); ƒ Trochanteric Fixation Nail (TFN) (Synthes; K011857 and more). ƒ Fixion® Interlocking Proximal Femur Intramedullary Nailing System (CarboFix; K010988, K012967 and more). Intended Use/Indications for Use Piccolo Composite Proximal Femur Nails The Piccolo Composite Proximal Femu…
Disc-O-Tech Medical Technologies, Ltd.20011
*K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System
Summary page 5
…e); ƒ Trochanteric Fixation Nail (TFN) (Synthes; K011857 and more). ƒ Fixion® Interlocking Proximal Femur Intramedullary Nailing System (CarboFix; K010988, K012967 and more). Intended Use/Indications for Use Piccolo Composite Proximal Femur Nails The Piccolo Composite Proximal Femur Nails a…
Disco-O-Tech Medical Technologies, Ltd.20011

Also cleared against K091425: 6 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.20161
K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 10, 2016Class IIZ-1991-2016OtherFirm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
  • 42 of the 157 ancestors have a recall of any class.
  • Of its descendants, K153536 (CarboFix Orthopedics, Ltd., 2016) has gone furthest, with 1 descendant of its own.
  • 6 other devices also cite its predicate K091425.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.

Indications for use as stated in the FDA summary.

Also cleared against K091425

6 other devices cite the same predicate.

  • K131636Polarus ConnectAcumed, LLC · 2013
  • K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  • K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 20111 recall
  • K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 20111 recall
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010

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Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K151010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151010: Piccolo Composite Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151010

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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