510(k) · Cleared
ClearedConnexx Locking Tibia Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.T.S. Implantat-Technologie-Systeme GmbH · JDS Nail, Fixation, Bone
Cleared on Jun 9, 2008 as substantially equivalent to K040762 (Synthes (Usa), 2004) and 6 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1992. 11 later devices descend from it.
- Decided
- Jun 9, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K914453 (1992). 16 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK914453 Universal Tibial Nail and Unreamed Tibial NailSynthes (Usa) · 1992
- 2 generations backK013430 Ace Bio Win Tibial Nailing SystemDePuy Orthopaedics, Inc. · 2001
- 1 generation backK032097 Depuy Ace Versanail Tibial NailDePuy Orthopaedics, Inc. · 2003
- This deviceK080706 Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008
- Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 2 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- Descendant · 3 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
- Descendant · 2 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
- K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 2 generations on3descendants
- K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 3 generations on2descendants
- K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on2descendants
- K230257Arthrex Intramedullary NailsArthrex, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914453 | Universal Tibial Nail and Unreamed Tibial Nail | Synthes (Usa) | 1992 | — |
| −2 | K013430 | Ace Bio Win Tibial Nailing System | DePuy Orthopaedics, Inc. | 2001 | — |
| −1 | K032097 | Depuy Ace Versanail Tibial Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K080706 | Connexx Locking Tibia Nail | I.T.S. Implantat-Technologie-Systeme GmbH | 2008 | — |
| +1 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +2 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| +3 | K181296 | Syntec Femoral Nail System | Syntec Scientific Corporation | 2019 | — |
| +2 | K141228 | Aos 6.5MM Captured, Fully Threaded Cancellous Screw | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +3 | K230257 | Arthrex Intramedullary Nails | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040762 | Synthes (Usa) Tibial Nail System EXSummary page 1…21 CFR, Sec. 888.3020) DEVICE PRODUCT CODE: HWC SUBSEQUENT PRODUCT CODE: HSB SUBSTANTIALLY Synthes Tibial Nail System (K040762) EQUIVALENT DEVICES DePuy/ACE VersaNail Tibial Nail (K032097) Synthes Cannulated Tibial Nail (K962… | 2004 |
| * | K032097 | Depuy Ace Versanail Tibial NailSummary page 1…WC SUBSEQUENT PRODUCT CODE: HSB SUBSTANTIALLY Synthes Tibial Nail System (K040762) EQUIVALENT DEVICES DePuy/ACE VersaNail Tibial Nail (K032097) Synthes Cannulated Tibial Nail (K962047) Synthes Universal Tibial Nail & Unrea… | 2003 |
| * | K962047 | Titanium Cannulated Tibial Nail (TI CTN)Summary page 1…Synthes Tibial Nail System (K040762) EQUIVALENT DEVICES DePuy/ACE VersaNail Tibial Nail (K032097) Synthes Cannulated Tibial Nail (K962047) Synthes Universal Tibial Nail & Unreamed Tibial Nail (K914453) BioPro Wujin #3… | 1996 |
| * | K914453 | Universal Tibial Nail and Unreamed Tibial NailSummary page 1…il Tibial Nail (K032097) Synthes Cannulated Tibial Nail (K962047) Synthes Universal Tibial Nail & Unreamed Tibial Nail (K914453) BioPro Wujin #3 Tibial Nail (K002325) Zimmer Sirus Intramedullary Nail-Femoral… | 1992 |
| * | K002325 | Wujin #3 Tibial NailSummary page 1…lated Tibial Nail (K962047) Synthes Universal Tibial Nail & Unreamed Tibial Nail (K914453) BioPro Wujin #3 Tibial Nail (K002325) Zimmer Sirus Intramedullary Nail-Femoral and Tibial Nail (K043270) Stryker Int… | 2000 |
| * | K043270 | Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Summary page 1…d Tibial Nail (K914453) BioPro Wujin #3 Tibial Nail (K002325) Zimmer Sirus Intramedullary Nail-Femoral and Tibial Nail (K043270) Stryker Interlocking Tibial Nailing System (K915435) DEVICE DESCRIPTION: The… | 2005 |
| * | K915435 | Interlocking Tibial Nailing SystemSummary page 1…K002325) Zimmer Sirus Intramedullary Nail-Femoral and Tibial Nail (K043270) Stryker Interlocking Tibial Nailing System (K915435) DEVICE DESCRIPTION: The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixation… | 1992 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail | 2014 | 10 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K132945 (I.T.S. GmbH, 2014) has gone furthest, with 10 descendants of its own.
- 10 other devices also cite its predicate K040762.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications for use include open and closed tibial shaft fractures" certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrothis of the tibial shaft, mataphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone transport, and fractures with bone loss.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080706 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080706: Connexx Locking Tibia Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080706
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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