510(k) Report

510(k) · Cleared

Cleared

Metafix and Fixion FA Intramedullary Nailing Systems

K071679510(k) TraditionalCleared Dec 17, 2007181-day reviewClass II21 CFR 888.3020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Dec 17, 2007 as substantially equivalent to K990717 (Disco-O-Tech Medical Technologies, Ltd., 1999) and 7 other predicates after a 181-day review. Its family tree reaches back 5 generations to 1997.

Decided
Dec 17, 2007
Review
181 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
8

Its longest line of descent runs back 5 generations to K970097 (1997). 26 ancestors in all, the oldest K803106 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1992: 4 other ancestors1990: 1 other ancestor2002: 1 other ancestor2000: 3 other ancestors1996: 1 other ancestor1994: 1 other ancestor1993: 3 other ancestors1989: 1 other ancestor1981: 1 other ancestor1997: 1 other ancestorK970097 · Proximal Femoral Nail (PFN) System · Synthes (Usa) · 1997×2: 2 generations cleared close together, K010988 (2001), K012967 (2001) K021324 · Fixion Intramedullary Nailing System (Fixion IM Nailing System) · Disco-O-Tech Medical Technologies, Ltd. · 2002 · recalledK023437 · Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail · Disco-O-Tech Medical Technologies, Ltd. · 2002198019851990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 15 other ancestors3 generations back: 1 other ancestor K023437 · Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail · Disco-O-Tech Medical Technologies, Ltd. · 2002K021324 · Fixion Intramedullary Nailing System (Fixion IM Nailing System) · Disco-O-Tech Medical Technologies, Ltd. · 2002 · recalledK012967 · 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) · 1997−50
  1. Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
  2. 4 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
  3. 3 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
  4. 2 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
  5. 1 generation backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
  6. This deviceK071679 Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K970097Proximal Femoral Nail (PFN) SystemSynthes (Usa)1997—
−4K010988Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd.20011
−3K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing…Disco-O-Tech Medical Technologies, Ltd.20011
−2K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.20021
−1K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF…Disco-O-Tech Medical Technologies, Ltd.2002—
0 (this device)K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198910
199010
199240
199330
199410
199610
199710
199910
200030
200120
200210
200410
FIG. 1 — Lineage of K071679, 1997–2007Source: 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? (8)

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 2
…ry Fixation Rod Class 1l; 21 CFR §888.3020 Product Code HSB Predicate Devices V Fixion Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (K990717, K010901) V Fixion PF Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (KO10988, K012967, K023437)…
Disco-O-Tech Medical Technologies, Ltd.1999—
*K010901Fixion Intramedullary Nailing System (Fixion Imn) Model B
Summary page 2
…on Rod Class 1l; 21 CFR §888.3020 Product Code HSB Predicate Devices V Fixion Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (K990717, K010901) V Fixion PF Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (KO10988, K012967, K023437) V Titaniu…
Disc-O-Tech Medical Technologies, Ltd.2001—
*K010988Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd.20011
*K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System
Summary page 2
…tem by Disc-O-Tech Medical Technologies Ltd. (K990717, K010901) V Fixion PF Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (KO10988, K012967, K023437) V Titanium Elastic Nail System by Synthes (K042135) V True/Flex Nail by Encore (K902264, K913949) Intended Use 1.…
Disco-O-Tech Medical Technologies, Ltd.20011
*K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…
Summary page 2
…sc-O-Tech Medical Technologies Ltd. (K990717, K010901) V Fixion PF Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (KO10988, K012967, K023437) V Titanium Elastic Nail System by Synthes (K042135) V True/Flex Nail by Encore (K902264, K913949) Intended Use 1. The Me…
Disco-O-Tech Medical Technologies, Ltd.2002—
*K042135Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)
Summary page 2
…010901) V Fixion PF Intramedullary Nailing System by Disc-O-Tech Medical Technologies Ltd. (KO10988, K012967, K023437) V Titanium Elastic Nail System by Synthes (K042135) V True/Flex Nail by Encore (K902264, K913949) Intended Use 1. The Meta-Fix Intramedullary Nailing System is intended for…
Synthes (Usa)2004—
*K902264True/Flex Humerus, Ulna and Radius Intramedullary
Summary page 2
…iling System by Disc-O-Tech Medical Technologies Ltd. (KO10988, K012967, K023437) V Titanium Elastic Nail System by Synthes (K042135) V True/Flex Nail by Encore (K902264, K913949) Intended Use 1. The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of long bon…
Applied Osteo Systems, Inc.1990—
*K913949True/Flex Humerus, Ulna & Radius Intramed Rods Sys
Summary page 2
…tem by Disc-O-Tech Medical Technologies Ltd. (KO10988, K012967, K023437) V Titanium Elastic Nail System by Synthes (K042135) V True/Flex Nail by Encore (K902264, K913949) Intended Use 1. The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of long bone fractur…
Applied Osteo Systems, Inc.1992—

Also cleared against K990717: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 3 companies; a new generation was cleared every 8 months on median.
  • 4 of the 26 ancestors have a recall of any class.
  • 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. 2007, this device’s year, is highlighted.

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 MetaFix Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.

The Fixion FA Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.

Indications for use as stated in the FDA summary.

Also cleared against K990717

4 other devices cite the same predicate.

  • 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
  • K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 20021 recall
  • K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001

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

16 FDA decisions under this applicant name. See the company

  • K071375Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)Disc-O-Tech Medical Technologies, Ltd. · 2007
  • K063067Confidence Fenestrated Introducer NeedleDisc-O-Tech Medical Technologies, Ltd. · 2006
  • K062424Confidence EX High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 2006
  • K060300Confidence High Viscosity Bone CementDisc-O-Tech Medical Technologies, Ltd. · 20068 recalls
  • K040612Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd. · 2004

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/K071679 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071679: Metafix and Fixion FA Intramedullary Nailing Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071679

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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