510(k) · Cleared
ClearedQuantum M Composite 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 Jan 21, 2010 as substantially equivalent to K933518 (Synthes (Usa), 1994) and 8 other predicates after a 253-day review. Its family tree reaches back 8 generations to 1984. 31 later devices descend from it.
- Decided
- Jan 21, 2010
- Review
- 253 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K841189 (1984). 56 ancestors in all, the oldest K791619 (1979). 31 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 2 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 1 generation backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- This deviceK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- Descendant · cites it directly · 29 of its ownK100497 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
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · cites it directly29descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −2 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −1 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| 0 (this device) | 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 | — |
| +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 | — |
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 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 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? (9)
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 |
|---|---|---|---|
| * | K933518 | Synthes Unreamed Humeral Nail (Urhn)Summary page 2…Ltd.L. Quantum TM Composite Nailing System ~ 09 ILf ZC) Predicate Devices Intended.Use/DsigynfJechmology/Operafion *UHN Humeral Nailing System (Syntbes; K9335 18) *Fixion' Interlocking Intrarnedullary Nailing System (N.M.B. Medical Applications, Ltd.; K(002783, K013449, K0… | 1994 |
| * | K002783 | Fixion Interlocking Nail (Fixion IL Nail)Summary page 2…erafion *UHN Humeral Nailing System (Syntbes; K9335 18) *Fixion' Interlocking Intrarnedullary Nailing System (N.M.B. Medical Applications, Ltd.; K(002783, K013449, K032588) * ntranrdullary Nail System (Smith & Nephew, Inc.; K983942) *KIMBATh Spinal Implant (SIGNUS Medizi… | 2000 |
| * | K013449 | Modification to Fixion Interlocking Intramedullary Nailing SystemSummary page 2…*UHN Humeral Nailing System (Syntbes; K9335 18) *Fixion' Interlocking Intrarnedullary Nailing System (N.M.B. Medical Applications, Ltd.; K(002783, K013449, K032588) * ntranrdullary Nail System (Smith & Nephew, Inc.; K983942) *KIMBATh Spinal Implant (SIGNUS Medizintechnik… | 2001 |
| * | K032588 | Modification to Fixion Intramedullary Nailing System (Fixion IM)Summary page 2…Humeral Nailing System (Syntbes; K9335 18) *Fixion' Interlocking Intrarnedullary Nailing System (N.M.B. Medical Applications, Ltd.; K(002783, K013449, K032588) * ntranrdullary Nail System (Smith & Nephew, Inc.; K983942) *KIMBATh Spinal Implant (SIGNUS Medizintechnik GimbH;, K… | 2003 |
| * | K983942 | Intramedullary Nail System, Locking Screw, Nail CapSummary page 2…nterlocking Intrarnedullary Nailing System (N.M.B. Medical Applications, Ltd.; K(002783, K013449, K032588) * ntranrdullary Nail System (Smith & Nephew, Inc.; K983942) *KIMBATh Spinal Implant (SIGNUS Medizintechnik GimbH;, K052533) *Spine~-TechTM Cement Restrictor (Centerpulsc, Spine… | 1998 |
| * | K052533 | Kimba Spinal ImplantSummary page 2…, Ltd.; K(002783, K013449, K032588) * ntranrdullary Nail System (Smith & Nephew, Inc.; K983942) *KIMBATh Spinal Implant (SIGNUS Medizintechnik GimbH;, K052533) *Spine~-TechTM Cement Restrictor (Centerpulsc, Spine-Tech Division; K0226 15) *Stackable Cage System (DePuy Spine, Inc… | 2005 |
| * | K022615 | Centerpulse, Spine-Tech Division Cement RestrictorSummary page 2…& Nephew, Inc.; K983942) *KIMBATh Spinal Implant (SIGNUS Medizintechnik GimbH;, K052533) *Spine~-TechTM Cement Restrictor (Centerpulsc, Spine-Tech Division; K0226 15) *Stackable Cage System (DePuy Spine, Inc.; K073 649) *Fixione DHS1 System (N.M.B. Medical Applications, Ltd.; K03 1401… | 2002 |
| * | K073649 | Bengal Stackable Cage SystemSummary page 2…SIGNUS Medizintechnik GimbH;, K052533) *Spine~-TechTM Cement Restrictor (Centerpulsc, Spine-Tech Division; K0226 15) *Stackable Cage System (DePuy Spine, Inc.; K073 649) *Fixione DHS1 System (N.M.B. Medical Applications, Ltd.; K03 1401) Intended Use/Indications for Use Indications for the… | 2008 |
| * | K031401 | Fixion Dynamic Hip Screw System (Fixion DHS)Summary page 2…ctor (Centerpulsc, Spine-Tech Division; K0226 15) *Stackable Cage System (DePuy Spine, Inc.; K073 649) *Fixione DHS1 System (N.M.B. Medical Applications, Ltd.; K03 1401) Intended Use/Indications for Use Indications for the Quantum TM Composite Humeral Nail include simple humerial fractures; s… | 2003 |
What descends from it? (31)
See all 317 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | 2010 | 29 |
| K102369 | Piccolo Composite Nailing System | 2011 | 16 |
| K111056 | Piccolo Composite Nailing System | 2011 | 15 |
| K102597 | Piccolo Composite Plate System | 2011 | 15 |
| K132774 | Piccolo Composite Nailing System | 2013 | 3 |
| K151010 | Piccolo Composite Nailing System | 2015 | 2 |
| K131636 | Polarus Connect | 2013 | 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 26 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 56 ancestors have a recall of any class.
- Of its descendants, K100497 (N.M.B. Medical Applications, Ltd., 2010) has gone furthest, with 29 descendants of its own.
- 5 other devices also cite its predicate K933518.
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?
Indications for the Quantum IM Composite Humeral 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 Quantum IM Composite Humeral Nail is 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/K091425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091425: Quantum M 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/K091425
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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