510(k) · Cleared
ClearedFixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail
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 Nov 14, 2002 as substantially equivalent to K010988 (Disc-O-Tech Medical Technologies, Ltd., 2001) and 9 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1997. 53 later devices descend from it.
- Decided
- Nov 14, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K970097 (1997). 23 ancestors in all, the oldest K803106 (1981). 53 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 3 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 2 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
- 1 generation backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
- This deviceK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
- Descendant · cites it directly · 32 of its ownK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · cites it directly · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · 2 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- Descendant · 3 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- Descendant · 2 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003 · cites it directly32descendants
- K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003 · cites it directly32descendants
- K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · 2 generations on31descendants
- K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 3 generations on29descendants
- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −3 | K010988 | Fixion Interlocking Proximal Femoral Nailing System | Disc-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −2 | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing… | Disco-O-Tech Medical Technologies, Ltd. | 2001 | 1 |
| −1 | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | 2002 | 1 |
| 0 (this device) | K023437 | Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF… | Disco-O-Tech Medical Technologies, Ltd. | 2002 | — |
| +1 | K032588 | Modification to Fixion Intramedullary Nailing System (Fixion IM) | Disco-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +1 | K031401 | Fixion Dynamic Hip Screw System (Fixion DHS) | Disco-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +2 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +3 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +2 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
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 |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010988 | Fixion Interlocking Proximal Femoral Nailing SystemSummary page 1…I, Hip joint femoral (hemi-hip) metaYpolyner cemented or uncemented prosthesis Predicate Devices 1. Fixion Interlocking Proximal Femoral Intramedullafy Nailing System (K010988,K012967) by Disc-0-Tech Medical Technologies, Ltd. Performance Standards The foltowing standards were used: 1. The Fixio… | 2001 |
| * | K012967 | Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing SystemSummary page 1…oint femoral (hemi-hip) metaYpolyner cemented or uncemented prosthesis Predicate Devices 1. Fixion Interlocking Proximal Femoral Intramedullafy Nailing System (K010988,K012967) by Disc-0-Tech Medical Technologies, Ltd. Performance Standards The foltowing standards were used: 1. The Fixion PI?Nai… | 2001 |
| * | K990717 | Fixion Intramedullary Nailing SystemSummary page 2…ms. The Fixion Interlocking Proximal Femoral Intramedullq Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM NaiIjng System - K990717, K003212, K003215, KO10901, K021324; Fixion lL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The mo… | 1999 |
| * | K003212 | Fixion Intramedullary Nailing System (Fixion IM Nail)Summary page 2…Fixion Interlocking Proximal Femoral Intramedullq Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM NaiIjng System - K990717, K003212, K003215, KO10901, K021324; Fixion lL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fi… | 2000 |
| * | K003215 | Modification of Fixion Intramedullary Nailing System (Fixion IM Nail)Summary page 2…terlocking Proximal Femoral Intramedullq Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM NaiIjng System - K990717, K003212, K003215, KO10901, K021324; Fixion lL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF N… | 2000 |
| * | K010901 | Fixion Intramedullary Nailing System (Fixion Imn) Model B | 2001 |
| * | K021324 | Fixion Intramedullary Nailing System (Fixion IM Nailing System)Summary page 2…l Femoral Intramedullq Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM NaiIjng System - K990717, K003212, K003215, KO10901, K021324; Fixion lL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF NaiIing System (mod… | 2002 |
| * | K002783 | Fixion Interlocking Nail (Fixion IL Nail)Summary page 2…m is substantially equivalent to the following cleared Fixion Systems: Fixion IM NaiIjng System - K990717, K003212, K003215, KO10901, K021324; Fixion lL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF NaiIing System (modified… | 2000 |
| * | K013449 | Modification to Fixion Interlocking Intramedullary Nailing SystemSummary page 2…tantially equivalent to the following cleared Fixion Systems: Fixion IM NaiIjng System - K990717, K003212, K003215, KO10901, K021324; Fixion lL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF NaiIing System (modified… | 2001 |
| * | K014072 | Fixion Unipolar Modular Hemi-Hip System (Fixion UH)Summary page 2…ared Fixion Systems: Fixion IM NaiIjng System - K990717, K003212, K003215, KO10901, K021324; Fixion lL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF NaiIing System (modified Page 2 of3… | 2002 |
What descends from it? (53)
See all 535 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032588 | Modification to Fixion Intramedullary Nailing System (Fixion IM) | 2003 | 32 |
| K031401 | Fixion Dynamic Hip Screw System (Fixion DHS) | 2003 | 32 |
| K032358 | B-Twin Bone Expander System (B-Twin BE System) | 2003 | 16 |
| K071679 | Metafix and Fixion FA Intramedullary Nailing Systems | 2007 | 0 |
| K032730 | Fixion Hip System | 2004 | 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 5 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K032588 (Disco-O-Tech Medical Technologies, Ltd., 2003) has gone furthest, with 32 descendants of its own.
- 11 other devices also cite its predicate K010988.
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: Hip: - femoral head/neck fractures or non-unions; - aseptic necrosis of the femoral head/neck; and - osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement Femur: - fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and…
Read the full statement (176 words)
These devices are indicated for the following:
Hip:
- femoral head/neck fractures or non-unions;
- aseptic necrosis of the femoral head/neck; and
- osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement
Femur:
- fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
- mid shaft fractures in 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 fractures;
- fixation of short distal or proximal fragments
Humerus:
- diaphyseal shaft fractures in the humerus;
- comminuted shaft fractures;
- fixation of short distal or proximal fragments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023437
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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