510(k) · Cleared
ClearedModification to Fixion Intramedullary Nailing System (Fixion IM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disco-O-Tech Medical Technologies, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Sep 12, 2003 as substantially equivalent to K990717 (Disco-O-Tech Medical Technologies, Ltd., 1999) and 11 other predicates after a 21-day review. Its family tree reaches back 5 generations to 1997. 32 later devices descend from it.
- Decided
- Sep 12, 2003
- Review
- 21 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 5 generations to K970097 (1997). 24 ancestors in all, the oldest K803106 (1981). 32 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 4 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 3 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 2 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- 1 generation backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- This deviceK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · cites it directly · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- Descendant · 2 generations on · 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 · 2 generations on · 15 of its ownK102597 Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd. · 2011
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · cites it directly31descendants
- K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 2 generations on29descendants
- 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 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −4 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −3 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −2 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| −1 | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| 0 (this device) | K032588 | Modification to Fixion Intramedullary Nailing System (Fixion IM) | Disco-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +1 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +2 | 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 |
| +2 | K102597 | Piccolo Composite Plate System | N.M.B. Medical Applications, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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? (12)
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 |
|---|---|---|---|
| * | K990717 | Fixion Intramedullary Nailing SystemSummary page 1…ailing System; Classification Name Intramedullary Fixation Rod 21 CFR 0 888.3020 Class I1 Predicate Devices 1. Fixion Intramedullary Nailing System (K9907 17, KO032 12, KO032 15, KO 10901, KO2 1324, K023437) by Disc-0-Tech. 2. Fixion Interlocking 1 ntramedullary Nailing Syste… | 1999 |
| * | K003212 | Fixion Intramedullary Nailing System (Fixion IM Nail) | 2000 |
| * | K003215 | Modification of Fixion Intramedullary Nailing System (Fixion IM Nail) | 2000 |
| * | K010901 | Fixion Intramedullary Nailing System (Fixion Imn) Model B | 2001 |
| * | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | 2002 |
| * | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Summary page 1…Fixation Rod 21 CFR 0 888.3020 Class I1 Predicate Devices 1. Fixion Intramedullary Nailing System (K9907 17, KO032 12, KO032 15, KO 10901, KO2 1324, K023437) by Disc-0-Tech. 2. Fixion Interlocking 1 ntramedullary Nailing System (K002783, KO1 3449, K023437) Page 16 of 27 === Pa… | 2002 |
| * | K002783 | Fixion Interlocking Nail (Fixion IL Nail)Summary page 1…tramedullary Nailing System (K9907 17, KO032 12, KO032 15, KO 10901, KO2 1324, K023437) by Disc-0-Tech. 2. Fixion Interlocking 1 ntramedullary Nailing System (K002783, KO1 3449, K023437) Page 16 of 27 Disc-0-Tech Medical Technologies, Ltd. Fixion Intramedullary Naili… | 2000 |
| * | K013449 | Modification to Fixion Interlocking Intramedullary Nailing System | 2001 |
| * | K010988 | Fixion Interlocking Proximal Femoral Nailing System | 2001 |
| * | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System | 2001 |
| * | K914453 | Universal Tibial Nail and Unreamed Tibial NailSummary page 2…Fixion Interlocking Proximal Femoral Intramedullary Nailing System (KO10988, KO 12967, K023437)i by Disc-0-Tech. 4. Unreamed Tibial Nail (K914453), by Synthes. 5. Universal Femoral Nail (K914371), by Synthes. Performance Standards The following s… | 1992 |
| * | K914371 | Universal Femoral NailSummary page 2…System (KO10988, KO 12967, K023437)i by Disc-0-Tech. 4. Unreamed Tibial Nail (K914453), by Synthes. 5. Universal Femoral Nail (K914371), by Synthes. Performance Standards The following standards were used: 1. The Fixion Intrameldullary Nail… | 1992 |
What descends from it? (32)
See all 323 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 6 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K091425 (N.M.B. Medical Applications, Ltd., 2010) has gone furthest, with 31 descendants of its own.
- 4 other devices also cite its predicate K990717.
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.
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?
These devices are indicated for the following: Femur: - fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; - proximal femoral fi-actures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these kactures; - use in osteotomy, rionunions and malunions, bone reconstruction…
Read the full statement (150 words)
These devices are indicated for the following:
Femur:
- fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures;
- proximal femoral fi-actures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these kactures;
- use in osteotomy, rionunions and malunions, bone reconstruction following tumor resection, grafting arid pathological fractures, and revision procedures in the femur;
- mid shaft fractures -1 the femur ( 5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures;
- fixation of short distal or proximal fragments
Tibia:
- diaphyseal shaft fractures in the tibia;
- comminuted shaft fi-actures;
- fixation of short distill or proximal fragments
Humerus:
- diaphyseal shaft fractures in the humerus;
- comminuted shaft hctures;
- fixation of short distal or proximal fragments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032588: Modification to Fixion Intramedullary Nailing System (Fixion IM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032588
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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