510(k) · Cleared
Recalled · Class II · 2025DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · JDS Nail, Fixation, Bone
Cleared on Sep 3, 2020 as substantially equivalent to K040762 (Synthes (Usa), 2004) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 2 times.
- Decided
- Sep 3, 2020
- Review
- 106 days
- Class
- Class II
- Product code
- JDS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000089 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000089 Synthes 4.0 and 5.0 MM Locking ScrewsSynthes (Usa) · 2000
- This deviceK201336 DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws…Synthes (USA) Products, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000089 | Synthes 4.0 and 5.0 MM Locking Screws | Synthes (Usa) | 2000 | — |
| 0 (this device) | K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary… | Synthes (USA) Products, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040762 | Synthes (Usa) Tibial Nail System EXSummary page 4…ne fixation fastener Device Classification Class II Primary Predicate Device: Synthes (USA) Tibial Nail System Ex (K040762) Additional Predicate Device: Predicate Devices Synthes 4.0 and 5.0 mm Locking… | 2004 |
| * | K000089 | Synthes 4.0 and 5.0 MM Locking ScrewsSummary page 4…) Tibial Nail System Ex (K040762) Additional Predicate Device: Predicate Devices Synthes 4.0 and 5.0 mm Locking Screws (K000089) Reference Device: DePuy Synthes Femoral Recon Nail System (K172157)… | 2000 |
| † | K172157 | DePuy Synthes Femoral Recon Nail System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2025 | Class II | Z-0228-2026 | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. |
| Sep 26, 2025 | Class II | Z-0229-2026 | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 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. 2020, 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?
DePuy Synthes Tibial Nail Advanced System:
The Tibial Nail Advanced implants are intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for:
• Open and closed proximal and distal tibial fractures
• Open and closed tibial shaft fractures
• Tibial malunions and nonunions
DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:
DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201336: DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201336
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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