510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Piccolo Composite Nailing System

K102369510(k) TraditionalCleared Jan 31, 2011164-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

N.M.B. Medical Applications, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jan 31, 2011 as substantially equivalent to K091425 (N.M.B. Medical Applications, Ltd., 2010) and 12 other predicates after a 164-day review. Its family tree reaches back 10 generations to 1984. 16 later devices descend from it. It has been recalled once.

Decided
Jan 31, 2011
Review
164 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
13

Its longest line of descent runs back 10 generations to K841189 (1984). 74 ancestors in all, the oldest K791619 (1979). 16 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 7 other ancestors2001: 11 other ancestors2000: 5 other ancestors1998: 2 other ancestors1996: 4 other ancestors1993: 3 other ancestors1992: 3 other ancestors2008: 1 other ancestor2005: 1 other ancestor2004: 3 other ancestors2002: 6 other ancestors1999: 4 other ancestors1997: 4 other ancestors1994: 1 other ancestor1990: 2 other ancestors1995: 1 other ancestor1989: 1 other ancestor1981: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1991: 1 other ancestor2013: 2 descendants cleared2015: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2019: 2 descendants cleared2017: 2 descendants cleared2023: 1 descendant cleared2020: 2 descendants cleared2025: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant cleared2026: 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 21 other ancestors3 generations back: 18 other ancestors4 generations back: 11 other ancestors5 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants K100497 · 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+5
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
  4. 2 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
  5. 1 generation backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  6. This deviceK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011
  7. Descendant · cites it directly · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
  8. Descendant · cites it directly · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  9. Descendant · 2 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  10. Descendant · 3 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020
  11. Descendant · 3 generations on · 6 of its ownK191782 TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019
Show all 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 4 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
  8. 3 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
  9. 2 generations backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
  10. 1 generation backK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  11. This deviceK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2011: 12013: 22015: 12016: 12017: 22019: 22020: 22021: 12023: 12024: 12025: 12026: 1
2011high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 16 · See all
  • K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · cites it directly15descendants
  • K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · cites it directly14descendants
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 2 generations on8descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 3 generations on6descendants
  • K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−6K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−5K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−4K043316Rabea Spinal ImplantSignus Medizintechnik GmbH2005—
−3K052533Kimba Spinal ImplantSignus Medizintechnik GmbH2005—
−2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.2010—
−1K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.2010—
0 (this device)K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011—
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20111
+1K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.2013—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198110
198610
198910
199020
199110
199230
199330
199410
199510
199640
199740
199820
199940
200050
2001110
200260
200370
200430
200510
200610
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201510
201610
201720
201920
202020
202110
202310
202410
202510
202610
FIG. 1 — Lineage of K102369, 1984–2026Source: 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? (13)

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 1
…Fixation, Intramedullaiy and Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices * Piccolo Composite Nailing System (N.M.B. Medical Applications, Ltd.; K091425, K100497); " Intramedullary Nail (Smith &Nephew, Inc.; K983942, K061019); " T2 Tibial Nail (Stryker (Howmedica Osteonics Cor…
N.M.B. Medical Applications, Ltd.2010—
*K100497Quantum IM Composite Nailing System (Quantum Nailing System)
Summary page 1
…tramedullaiy and Accessories (21 CFR §888.3020; Product Code HSB) Predicate Devices * Piccolo Composite Nailing System (N.M.B. Medical Applications, Ltd.; K091425, K100497); " Intramedullary Nail (Smith &Nephew, Inc.; K983942, K061019); " T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018…
N.M.B. Medical Applications, Ltd.2010—
*K983942Intramedullary Nail System, Locking Screw, Nail Cap
Summary page 1
…Code HSB) Predicate Devices * Piccolo Composite Nailing System (N.M.B. Medical Applications, Ltd.; K091425, K100497); " Intramedullary Nail (Smith &Nephew, Inc.; K983942, K061019); " T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more);…
Smith & Nephew, Inc.1998—
*K061019Trigen Meta-Nail Retrograde Femoral and Tibial Nails
Summary page 1
…) Predicate Devices * Piccolo Composite Nailing System (N.M.B. Medical Applications, Ltd.; K091425, K100497); " Intramedullary Nail (Smith &Nephew, Inc.; K983942, K061019); " T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more);…
Smith & Nephew, Inc.20061
*K003018Titan Tibial Nail
Summary page 1
…Medical Applications, Ltd.; K091425, K100497); " Intramedullary Nail (Smith &Nephew, Inc.; K983942, K061019); " T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more); K\Q2-34,ct (?I…
Howmedica Osteonics Corp.200022
*K010801T2 Femoral Nail
Summary page 2
…K\Q2-34,ct (?IS) N.MAR Medical Applications, Ltd. Piccolo Composite" 4 Nailing System - Tibia & Femur a T2 Femoral Nail (Stryker (Howinedica Osteonics Corp.); K010801 and more). 0 UrN Solid Tibial NaiIICTN Cannulated Tibial Nail (Synthes; K(914453,1K962047). N UFN Unreamned Femoral NaiI/CFN Ca…
Howmedica Osteonics Corp.20012
*K914453Universal Tibial Nail and Unreamed Tibial Nail
Summary page 2
…g System - Tibia & Femur a T2 Femoral Nail (Stryker (Howinedica Osteonics Corp.); K010801 and more). 0 UrN Solid Tibial NaiIICTN Cannulated Tibial Nail (Synthes; K(914453,1K962047). N UFN Unreamned Femoral NaiI/CFN Cannulated Femoral Nail (Synthes; K(923580, K954 85 6) N Fixion Interlocking Int…
Synthes (Usa)1992—
*K962047Titanium Cannulated Tibial Nail (TI CTN)
Summary page 2
…- Tibia & Femur a T2 Femoral Nail (Stryker (Howinedica Osteonics Corp.); K010801 and more). 0 UrN Solid Tibial NaiIICTN Cannulated Tibial Nail (Synthes; K(914453,1K962047). N UFN Unreamned Femoral NaiI/CFN Cannulated Femoral Nail (Synthes; K(923580, K954 85 6) N Fixion Interlocking Intramedulla…
Synthes (Usa)1996—
*K923580Synthes TI-6AI-7NB Unreamed Femoral Nail
Summary page 2
…010801 and more). 0 UrN Solid Tibial NaiIICTN Cannulated Tibial Nail (Synthes; K(914453,1K962047). N UFN Unreamned Femoral NaiI/CFN Cannulated Femoral Nail (Synthes; K(923580, K954 85 6) N Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd.; K002783, KO013449,…
Synthes (Usa)1993—
*K954856Cannulated Femoral Nail
Summary page 2
…more). 0 UrN Solid Tibial NaiIICTN Cannulated Tibial Nail (Synthes; K(914453,1K962047). N UFN Unreamned Femoral NaiI/CFN Cannulated Femoral Nail (Synthes; K(923580, K954 85 6) N Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd.; K002783, KO013449, K032588) Int…
Synthes (Usa)1996—
*K002783Fixion Interlocking Nail (Fixion IL Nail)
Summary page 2
…Femoral NaiI/CFN Cannulated Femoral Nail (Synthes; K(923580, K954 85 6) N Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd.; K002783, KO013449, K032588) Intended Use(ndknations for Use Piccolo Conmosite Tibia! and Femoral Nails Indications for the Piccolo Comp…
Disco-O-Tech Medical Technologies, Ltd.2000—
*K013449Modification to Fixion Interlocking Intramedullary Nailing System
Summary page 2
…I/CFN Cannulated Femoral Nail (Synthes; K(923580, K954 85 6) N Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd.; K002783, KO013449, K032588) Intended Use(ndknations for Use Piccolo Conmosite Tibia! and Femoral Nails Indications for the Piccolo Composite Tibi…
Disc-O-Tech Medical Technologies, Ltd.2001—
*K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)
Summary page 2
…nnulated Femoral Nail (Synthes; K(923580, K954 85 6) N Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd.; K002783, KO013449, K032588) Intended Use(ndknations for Use Piccolo Conmosite Tibia! and Femoral Nails Indications for the Piccolo Composite Tibial and Fe…
Disco-O-Tech Medical Technologies, Ltd.2003—

Also cleared against K091425: 6 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201115
K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314
K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133
K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20152
K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.20161

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 27 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
  • 15 of the 74 ancestors have a recall of any class.
  • Of its descendants, K111056 (CarboFix Orthopedics, Ltd., 2011) has gone furthest, with 15 descendants 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. 2011, 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?

Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

Indications for use as stated in the FDA summary.

Also cleared against K091425

6 other devices cite the same predicate.

  • K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 20151 recall
  • 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
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010

More from N.M.B. Medical Applications, Ltd.

4 FDA decisions under this applicant name. See the company

  • K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
  • K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
  • K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010

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/K102369 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102369: Piccolo Composite Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102369

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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