510(k) · Cleared
Recalled · Class II · 2013Synthes Suprapatellar Insertion Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDS Nail, Fixation, Bone
Cleared on Dec 5, 2011 as substantially equivalent to K040762 (Synthes (Usa), 2004) and 1 other predicate after a 174-day review. Its family tree reaches back 4 generations to 1995. 18 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 2011
- Review
- 174 days
- Class
- Class II
- Product code
- JDS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951740 (1995). 11 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 3 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 2 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 1 generation backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011
- Descendant · cites it directly · 17 of its ownK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- Descendant · 2 generations on · 11 of its ownK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
- Descendant · 3 generations on · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
- Descendant · 4 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
- Descendant · 4 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K131365T2 Tibial Nailing SystemStryker Trauma AG · 2013 · cites it directly17descendants
- K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH · 2020 · 2 generations on11descendants
- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · 3 generations on7descendants
- K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · 4 generations on3descendants
- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −3 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −2 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −1 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | — |
| +1 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| +2 | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail… | Stryker GmbH | 2020 | — |
| +3 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF… | Stryker GmbH | 2021 | — |
| +4 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | 1 |
| +4 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 1…fixation appliance and accessories. Product Code: JOS (Nail, Fixation, Bone) Predicate Synthes (USA) Tibial Nail System EX ( K040762 ) Devices: Smith & Nephew Trioen® Meta-Nail Retrograde Femoral and Tibial Nail System (K06… | 2004 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsSummary page 1…nthes (USA) Tibial Nail System EX ( K040762 ) Devices: Smith & Nephew Trioen® Meta-Nail Retrograde Femoral and Tibial Nail System (K061019). Device The Synthes (USA) Suprapatellar Insertion Instruments consist of Description: aiming arms,… | 2006 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131365 | T2 Tibial Nailing System | 2013 | 17 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2013 | Class II | Z-0404-2014 | Labeling mix-ups | Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. |
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 5.5 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K131365 (Stryker Trauma AG, 2013) has gone furthest, with 17 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. 2011, 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?
The Synthes Suprapatellar Insertion Instruments are part of the Synthes Tibial Nail System EX. The Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111667: Synthes Suprapatellar Insertion Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111667
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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