510(k) Report

510(k) · Cleared

Recalled · 2002

Fixion Intramedullary Nailing System (Fixion IM Nailing System)

K021324510(k) SpecialCleared May 23, 200227-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

Disco-O-Tech Medical Technologies, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 23, 2002 as substantially equivalent to K990717 (Disco-O-Tech Medical Technologies, Ltd., 1999) and 5 other predicates after a 27-day review. Its family tree reaches back 3 generations to 1997. 54 later devices descend from it. It has been recalled once.

Decided
May 23, 2002
Review
27 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
6

Its longest line of descent runs back 3 generations to K970097 (1997). 18 ancestors in all, the oldest K803106 (1981). 54 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 3 other ancestors1999: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestor1993: 3 other ancestors1992: 3 other ancestors1989: 1 other ancestor1981: 1 other ancestor2003: 3 descendants cleared2002: 1 descendant cleared2007: 2 descendants cleared2004: 4 descendants cleared2011: 3 descendants cleared2010: 2 descendants cleared2015: 2 descendants cleared2013: 4 descendants cleared2016: 3 descendants cleared2006: 1 descendant cleared2012: 1 descendant cleared2017: 3 descendants cleared2020: 5 descendants cleared2018: 2 descendants cleared2019: 3 descendants cleared2009: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2014: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2021: 2 descendants clearedK970097 · Proximal Femoral Nail (PFN) System · Synthes (Usa) · 1997×2: 2 generations cleared close together, K010988 (2001), K012967 (2001) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 11 other ancestors 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 9 descendants4 generations forward: 13 descendants5 generations forward: 7 descendants6 generations forward: 5 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant10 generations forward: 1 descendant11 generations forward: 1 descendant K012967 · Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System · Disco-O-Tech Medical Technologies, Ltd. · 2001 · recalledK010988 · Fixion Interlocking Proximal Femoral Nailing System · Disc-O-Tech Medical Technologies, Ltd. · 2001 · recalledK970097 · Proximal Femoral Nail (PFN) System · Synthes (Usa) · 19970+5+10
  1. Root · 3 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
  2. 2 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
  3. 1 generation backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
  4. This deviceK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002
  5. Descendant · cites it directly · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
  6. Descendant · cites it directly · 32 of its ownK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
  7. Descendant · 2 generations on · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
  8. Descendant · 2 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
  9. Descendant · 3 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2002: 12003: 32004: 42006: 12007: 22009: 12010: 22011: 32012: 12013: 42014: 22015: 22016: 32017: 32018: 22019: 32020: 52021: 22022: 22023: 22024: 22025: 22026: 2
2002high 5 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 54 · See all
  • K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd. · 2002 · cites it directly53descendants
  • 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 · 2 generations on32descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970097Proximal Femoral Nail (PFN) SystemSynthes (Usa)1997—
−2K010988Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd.20011
−1K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing…Disco-O-Tech Medical Technologies, Ltd.20011
0 (this device)K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.2002—
+1K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF…Disco-O-Tech Medical Technologies, Ltd.2002—
+1K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.2003—
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.2003—
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.2010—
+3K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198910
199230
199330
199410
199610
199910
200030
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200330
200440
200610
200720
200910
201020
201130
201210
201340
201420
201520
201630
201730
201820
201930
202050
202120
202220
202320
202420
202520
202620
FIG. 1 — Lineage of K021324, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (6)

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
*K990717Fixion Intramedullary Nailing System
Summary page 1
…on IM Nailing System) Classification Name Intramedullary Fixation Rod 21 CFR § 888.3020 Class II Predicate Devices paqe | N 1. Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech. 2. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K0…
Disco-O-Tech Medical Technologies, Ltd.1999—
*K003212Fixion Intramedullary Nailing System (Fixion IM Nail)
Summary page 1
…ling System) Classification Name Intramedullary Fixation Rod 21 CFR § 888.3020 Class II Predicate Devices paqe | N 1. Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech. 2. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967) by…
Disco-O-Tech Medical Technologies, Ltd.2000—
*K003215Modification of Fixion Intramedullary Nailing System (Fixion IM Nail)
Summary page 1
…em) Classification Name Intramedullary Fixation Rod 21 CFR § 888.3020 Class II Predicate Devices paqe | N 1. Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech. 2. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967) by Disc-O-T…
Disco-O-Tech Medical Technologies, Ltd.2000—
*K010901Fixion Intramedullary Nailing System (Fixion Imn) Model B
Summary page 1
…ification Name Intramedullary Fixation Rod 21 CFR § 888.3020 Class II Predicate Devices paqe | N 1. Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech. 2. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967) by Disc-O-Tech. Page…
Disc-O-Tech Medical Technologies, Ltd.2001—
*K010988Fixion Interlocking Proximal Femoral Nailing System
Summary page 1
…N 1. Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech. 2. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967) by Disc-O-Tech. Page 22 of 33 Disc-O-Tech Medical Technologies, Ltd. Fixion Intramedullary Nailing Sys…
Disc-O-Tech Medical Technologies, Ltd.20011
*K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System
Summary page 1
…ion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech. 2. Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, K012967) by Disc-O-Tech. Page 22 of 33 Disc-O-Tech Medical Technologies, Ltd. Fixion Intramedullary Nailing System K O))…
Disco-O-Tech Medical Technologies, Ltd.20011

Also cleared against K990717: 4 other devices →

What descends from it? (54)

See all 54

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

NumberDeviceApplicantDecidedDescendants
K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd.200253
K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.200332

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 11, 2002Not classifiedZ-0943-03OtherThe Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.

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.
  • 2 of the 18 ancestors have a recall of any class.
  • Of its descendants, K023437 (Disco-O-Tech Medical Technologies, Ltd., 2002) has gone furthest, with 53 descendants of its own.
  • 4 other devices also cite its predicate K990717.

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.

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?

The Fixion Intramedullary Nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia and femur. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K990717

4 other devices cite the same predicate.

  • K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd. · 2007
  • K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
  • K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion…Disco-O-Tech Medical Technologies, Ltd. · 2002
  • K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001

More from Disco-O-Tech Medical Technologies, Ltd.

9 FDA decisions under this applicant name. See the company

  • K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
  • K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
  • K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion…Disco-O-Tech Medical Technologies, Ltd. · 2002
  • K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 20011 recall
  • K003212Fixion Intramedullary Nailing System (Fixion IM Nail)Disco-O-Tech Medical Technologies, Ltd. · 2000

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/K021324 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021324: Fixion Intramedullary Nailing System (Fixion IM Nailing System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021324

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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