510(k) · Cleared
ClearedQuantum IM Composite Nailing System (Quantum Nailing System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
N.M.B. Medical Applications, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 21, 2010 as substantially equivalent to K091425 (N.M.B. Medical Applications, Ltd., 2010) and 4 other predicates after a 119-day review. Its family tree reaches back 9 generations to 1984. 29 later devices descend from it.
- Decided
- Jun 21, 2010
- Review
- 119 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K841189 (1984). 63 ancestors in all, the oldest K791619 (1979). 29 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 2 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 1 generation backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- This deviceK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- Descendant · cites it directly · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 15 of its ownK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
- Descendant · 2 generations on · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
- Descendant · 2 generations on · 11 of its ownK120409 Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 2 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 1 generation backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- This deviceK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly16descendants
- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · cites it directly15descendants
- K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly15descendants
- K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on14descendants
- K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd. · 2012 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −2 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −1 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| 0 (this device) | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +1 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| +1 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
| +1 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
| +2 | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | CarboFix Orthopedics, Ltd. | 2013 | — |
| +2 | K120409 | Piccolo Composite Plate System | CarboFix Orthopedics, Ltd. | 2012 | — |
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 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K091425 | Quantum M Composite Nailing SystemSummary page 2…N.M.B. Medical Applications Ltd. Piccolo Composite Nailing System Predicate Devices * Quantum IM Composite Nailing System (N.M.B. Medical Applications, Ltd.; K09 1425); * TriGen Straight Humeral Nail System (Smith & Nephew, Inc.; K032722); *T2 Nailing System / T2 Proximal Humnera'l Nail (H… | 2010 |
| * | K032722 | Trigen Straight Humeral Nail SystemSummary page 2…ate Devices * Quantum IM Composite Nailing System (N.M.B. Medical Applications, Ltd.; K09 1425); * TriGen Straight Humeral Nail System (Smith & Nephew, Inc.; K032722); *T2 Nailing System / T2 Proximal Humnera'l Nail (Howmedica Osteonics Corp.; K032523, K042396, K043404); Intended Use… | 2003 |
| * | K032523 | T2 Nailing SystemSummary page 2…K09 1425); * TriGen Straight Humeral Nail System (Smith & Nephew, Inc.; K032722); *T2 Nailing System / T2 Proximal Humnera'l Nail (Howmedica Osteonics Corp.; K032523, K042396, K043404); Intended Use/Indications for Use Piccolo Composite Humneral and Proximal Humerus Nails Indications for the… | 2003 |
| * | K042396 | T2 Proximal Humeral NailSummary page 2…; * TriGen Straight Humeral Nail System (Smith & Nephew, Inc.; K032722); *T2 Nailing System / T2 Proximal Humnera'l Nail (Howmedica Osteonics Corp.; K032523, K042396, K043404); Intended Use/Indications for Use Piccolo Composite Humneral and Proximal Humerus Nails Indications for the Piccolo C… | 2004 |
| * | K043404 | Modification to T2 Proximal Humeral NailSummary page 2…iGen Straight Humeral Nail System (Smith & Nephew, Inc.; K032722); *T2 Nailing System / T2 Proximal Humnera'l Nail (Howmedica Osteonics Corp.; K032523, K042396, K043404); Intended Use/Indications for Use Piccolo Composite Humneral and Proximal Humerus Nails Indications for the Piccolo Composite… | 2004 |
What descends from it? (29)
See all 295 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 26 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 10 of the 63 ancestors have a recall of any class.
- Of its descendants, K102369 (N.M.B. Medical Applications, Ltd., 2011) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K091425.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
Piccolo Composite Humeral and Proximal Humerus Nails
Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100497: Quantum IM Composite Nailing System (Quantum 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/K100497
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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