510(k) · Cleared
ClearedSynthes (Usa) DHS Helix System
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 Jul 17, 1998 after a 59-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 59 days
- Class
- Class II
- Product code
- JDO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK981757 Synthes (Usa) DHS Helix SystemSynthes (Usa) · 1998
- Descendant · cites it directly · 2 of its ownK080685 Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK140018 TSP Hip Fracture Plating SystemBiomet, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK173826 THP Hip Fracture Plating SystemBiomet, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK103015 Odrc-Dynamic Hip Screw SystemOrthopaedic Device Research Center · 2011
Most influential descendants
Showing 4 of 4 · See all- K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 2008 · cites it directly2descendants
- K140018TSP Hip Fracture Plating SystemBiomet, Inc. · 2014 · 2 generations on1descendant
- K173826THP Hip Fracture Plating SystemBiomet, Inc. · 2018 · 3 generations on0descendants
- K103015Odrc-Dynamic Hip Screw SystemOrthopaedic Device Research Center · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981757 | Synthes (Usa) DHS Helix System | Synthes (Usa) | 1998 | — |
| +1 | K080685 | Hiploc Compression Hip Screw | Biomet Manufacturing, Inc. | 2008 | 4 |
| +2 | K140018 | TSP Hip Fracture Plating System | Biomet, Inc. | 2014 | 2 |
| +3 | K173826 | THP Hip Fracture Plating System | Biomet, Inc. | 2018 | — |
| +1 | K103015 | Odrc-Dynamic Hip Screw System | Orthopaedic Device Research Center | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 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 LC-DHS Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K080685 (Biomet Manufacturing, Inc., 2008) has gone furthest, with 2 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?
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/K981757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981757: Synthes (Usa) DHS Helix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981757
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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