510(k) Report

510(k) · Cleared

Cleared

Titanium Cannulated Tibial Nail (TI CTN)

K962047510(k) TraditionalCleared Jul 24, 199657-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 Jul 24, 1996 after a 57-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.

Decided
Jul 24, 1996
Review
57 days
Class
Class II
Product code
JDS
Recalls
None
Predicates
0

36 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2024: 3 descendants cleared2008: 1 descendant cleared2020: 5 descendants cleared2011: 2 descendants cleared2014: 2 descendants cleared2018: 1 descendant cleared2013: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2017: 4 descendants cleared2026: 4 descendants cleared2021: 2 descendants cleared2019: 4 descendants cleared2023: 2 descendants cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK962047 Titanium Cannulated Tibial Nail (TI CTN)Synthes (Usa) · 1996
  2. Descendant · cites it directly · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
  3. Descendant · cites it directly · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
  4. Descendant · 2 generations on · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  5. Descendant · cites it directly · 11 of its ownK080706 Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008
  6. Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2008: 12011: 22013: 22014: 22015: 12016: 12017: 42018: 12019: 42020: 52021: 22023: 22024: 32025: 22026: 4
2008high 5 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 36 · See all
  • K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · cites it directly16descendants
  • K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · cites it directly15descendants
  • K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on14descendants
  • K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · cites it directly11descendants
  • K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962047Titanium Cannulated Tibial Nail (TI CTN)Synthes (Usa)1996—
+1K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.20111
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20111
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.2013—
+1K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH2008—
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…I.T.S. GmbH2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201120
201320
201420
201510
201610
201740
201810
201940
202050
202120
202320
202430
202520
202640
FIG. 1 — Lineage of K962047, 1996–2026Source: 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 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? (2)

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
*—Synthes Ti-6Al-7Nb Unreamed Tibial Nail
Named without a submission number
—
*—Synthes Titanium Tibial Nail System
Named without a submission number
—

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
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
K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410
K192003Auxein Nailing SystemAuxein Medical Private Limited20202
K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182
K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd.20240

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, K102369 (N.M.B. Medical Applications, Ltd., 2011) has gone furthest, with 16 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—

What is it indicated for?

Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.

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

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/K962047 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962047: Titanium Cannulated Tibial Nail (TI CTN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962047

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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