510(k) · Cleared
ClearedTitanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDO Device, Fixation, Proximal Femoral, Implant
Cleared on Mar 8, 1996 after a 219-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Mar 8, 1996
- Review
- 219 days
- Class
- Class II
- Product code
- JDO
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 8 citing it directly.
- This deviceK953607 Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Synthes (Usa) · 1996
- Descendant · cites it directly · 13 of its ownK102057 Targon FN SystemAesculap Implant Systems, LLC · 2010
- Descendant · 2 generations on · 12 of its ownK152686 Conquest FNSmith & Nephew · 2016
- Descendant · 3 generations on · 10 of its ownK193029 Conquest FNSmith & Nephew, Inc. · 2020
- Descendant · 2 generations on · 8 of its ownK172785 Conquest FNSmith & Nephew · 2017
- Descendant · 3 generations on · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K102057Targon FN SystemAesculap Implant Systems, LLC · 2010 · cites it directly13descendants
- K152686Conquest FNSmith & Nephew · 2016 · 2 generations on12descendants
- K193029Conquest FNSmith & Nephew, Inc. · 2020 · 3 generations on10descendants
- K172785Conquest FNSmith & Nephew · 2017 · 2 generations on8descendants
- K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953607 | Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS) | Synthes (Usa) | 1996 | — |
| +1 | K102057 | Targon FN System | Aesculap Implant Systems, LLC | 2010 | — |
| +2 | K152686 | Conquest FN | Smith & Nephew | 2016 | — |
| +3 | K193029 | Conquest FN | Smith & Nephew, Inc. | 2020 | — |
| +2 | K172785 | Conquest FN | Smith & Nephew | 2017 | — |
| +3 | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 JDO? 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 JDO device
- #1 K213126 Smith & Nephew, Inc. Plates and Screws…score 12.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Synthes Dynamic Hip Screw (DHS) Implant Named without a submission number |
What descends from it? (25)
See all 258 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102057 | Targon FN System | 2010 | 13 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 | 3 |
| K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND… | 2017 | 3 |
| K210247 | OsteoCentric Integrated Hip Fastener System | 2021 | 1 |
| K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of… | 2016 | 1 |
| K150561 | NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of… | 2015 | 1 |
| K093707 | Dyna Locking Trochanteric Nail, Model NG0820 | 2010 | 1 |
| K230764 | OsteoCentric Integrated Hip Fastener System | 2023 | 0 |
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, K102057 (Aesculap Implant Systems, LLC, 2010) has gone furthest, with 13 descendants of its own.
How does its category compare?
All JDO devicesJDO Device, Fixation, Proximal Femoral, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JDO
Too few JDO 510(k)s in any year since 2007 to give a median.
Recalls per year · JDO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDO
1in 2025
MAUDE reports naming product code JDO, 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 | 0 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 1 | 52 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 1 | — | 0 | 44 |
| 2017 | 1 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Synthes Ti. LC-DHS is a sliding hip screw plate device, intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953607: Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953607
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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