510(k) Report

510(k) · Cleared

Cleared

Universal Tibial Nail and Unreamed Tibial Nail

K914453510(k) TraditionalCleared Feb 18, 1992137-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

Synthes (Usa) · JDS Nail, Fixation, Bone

Cleared on Feb 18, 1992 after a 137-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 118 later devices descend from it.

Decided
Feb 18, 1992
Review
137 days
Class
Class II
Product code
JDS
Recalls
None
Predicates
0

118 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2024: 5 descendants cleared2009: 3 descendants cleared2008: 2 descendants cleared2001: 2 descendants cleared2006: 2 descendants cleared2003: 4 descendants cleared2011: 3 descendants cleared2014: 5 descendants cleared1996: 1 descendant cleared2018: 7 descendants cleared2010: 3 descendants cleared2002: 2 descendants cleared2015: 4 descendants cleared2013: 7 descendants cleared2016: 3 descendants cleared2020: 9 descendants cleared2026: 10 descendants cleared1997: 1 descendant cleared2007: 3 descendants cleared2004: 4 descendants cleared2012: 2 descendants cleared2019: 6 descendants cleared2017: 5 descendants cleared2023: 6 descendants cleared2025: 10 descendants cleared2022: 5 descendants cleared2021: 3 descendants cleared1990200020102020
  1. This deviceK914453 Universal Tibial Nail and Unreamed Tibial NailSynthes (Usa) · 1992
  2. Descendant · cites it directly · 56 of its ownK990717 Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 1999
  3. Descendant · 2 generations on · 54 of its ownK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
  4. Descendant · cites it directly · 54 of its ownK013449 Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001
  5. Descendant · 2 generations on · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
  6. Descendant · cites it directly · 48 of its ownK013430 Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001

Showing 5 of 118 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11999: 12001: 22002: 22003: 42004: 42006: 22007: 32008: 22009: 32010: 32011: 32012: 22013: 72014: 52015: 42016: 32017: 52018: 72019: 62020: 92021: 32022: 52023: 62024: 52025: 102026: 10
1996high 10 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 118 · See all
  • K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 1999 · cites it directly56descendants
  • K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · 2 generations on54descendants
  • 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 · 2 generations on53descendants
  • K013430Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001 · cites it directly48descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914453Universal Tibial Nail and Unreamed Tibial NailSynthes (Usa)1992—
+1K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.1999—
+2K021324Fixion 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—
+2K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF…Disco-O-Tech Medical Technologies, Ltd.2002—
+1K013430Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199910
200120
200220
200340
200440
200620
200730
200820
200930
201030
201130
201220
201370
201450
201540
201630
201750
201870
201960
202090
202130
202250
202360
202450
2025100
2026100
FIG. 1 — Lineage of K914453, 1992–2026Source: 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), 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? (118)

See all 118

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

NumberDeviceApplicantDecidedDescendants
K990717Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd.199956
K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.200154
K013430Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc.200148
K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.200332
K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.201116
K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201115
K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811
K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH20063
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182
K133166Ins Hilden Tibial ArzztTruemed Group, LLC20141

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, K990717 (Disco-O-Tech Medical Technologies, Ltd., 1999) has gone furthest, with 56 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 Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K914453 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914453: Universal Tibial Nail and Unreamed Tibial Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914453

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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