510(k) Report

510(k) · Cleared

Cleared

Fixion Intramedullary Nailing System (Fixion IM Nail)

K003212510(k) TraditionalCleared Dec 28, 200076-day reviewClass II21 CFR 888.3030

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. · JDS Nail, Fixation, Bone

Cleared on Dec 28, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.

Decided
Dec 28, 2000
Review
76 days
Class
Class II
Product code
JDS
Recalls
None
Predicates
0

56 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2003: 3 descendants cleared2002: 2 descendants cleared2011: 3 descendants cleared2010: 2 descendants cleared2007: 2 descendants cleared2004: 4 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 cleared200020052010201520202025
  1. This deviceK003212 Fixion Intramedullary Nailing System (Fixion IM Nail)Disco-O-Tech Medical Technologies, Ltd. · 2000
  2. Descendant · cites it directly · 54 of its ownK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
  3. Descendant · cites it directly · 54 of its ownK013449 Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001
  4. Descendant · cites it directly · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
  5. Descendant · cites it directly · 32 of its ownK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
  6. Descendant · 2 generations on · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22003: 32004: 42006: 12007: 22009: 12010: 22011: 32012: 12013: 42014: 22015: 22016: 32017: 32018: 22019: 32020: 52021: 22022: 22023: 22024: 22025: 22026: 2
2001high 5 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 56 · See all
  • K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · cites it directly54descendants
  • K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · cites it directly54descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003212Fixion Intramedullary Nailing System (Fixion IM Nail)Disco-O-Tech Medical Technologies, Ltd.2000—
+1K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.20021
+1K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.2001—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
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 K003212, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JDS? 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 JDS device

  1. #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd.200254
K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.200154
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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K021324 (Disco-O-Tech Medical Technologies, Ltd., 2002) has gone furthest, with 54 descendants of its own.

How does its category compare?

All JDS devices

JDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDS

1in 2025

2007: 22008: 12011: 12013: 12015: 12020: 32023: 12024: 32025: 1
2007high 3 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDS

146in 2024

2020: 106 days median2024: 146 days median
2007high 146 (2024) · low 106 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDS

2in 2025

2009: 32010: 22013: 42017: 12020: 12025: 2
2007high 4 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDS

497in 2025

2007: 1612008: 1692009: 1602010: 702011: 1042012: 1952013: 2842014: 3882015: 3162016: 5062017: 2872018: 3202019: 4902020: 6432021: 6302022: 5892023: 3572024: 4662025: 497
2007high 643 (2020) · low 70 (2010)2025

MAUDE reports naming product code JDS, 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
20072—0161
20081—0169
20090—3160
20100—270
20111—0104
20120—0195
20131—4284
20140—0388
20151—0316
20160—0506
20170—1287
20180—0320
20190—0490
202031061643
20210—0630
20220—0589
20231—0357
202431460466
20251—2497
20260—0—

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
  • K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 20021 recall
  • K012967Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 20011 recall

Recent decisions in JDS

The JDS category page

  • K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc. · 2025
  • K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc. · 2024
  • K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc. · 2024
  • K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd. · 2024
  • K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc. · 2023

https://510kreport.com/device/K003212 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003212: Fixion Intramedullary Nailing System (Fixion IM Nail).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003212

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026