510(k) · Cleared
ClearedThe Corifix Dynamic Hip Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 20, 1997 after an 85-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Nov 20, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK973231 The Corifix Dynamic Hip Screw SystemCorin USA · 1997
- Descendant · cites it directly · 4 of its ownK071852 Aap Aps SystemAap Implantate AG · 2007
- Descendant · 2 generations on · 2 of its ownK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
- Descendant · 3 generations on · 1 of its ownK202764 Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK221787 Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023
- Descendant · 3 generations on · 0 of its ownK210658 Volition Plating SystemOrtho Solutions UK, Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K071852Aap Aps SystemAap Implantate AG · 2007 · cites it directly4descendants
- K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on2descendants
- K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020 · 3 generations on1descendant
- K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023 · 2 generations on0descendants
- K210658Volition Plating SystemOrtho Solutions UK, Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973231 | The Corifix Dynamic Hip Screw System | Corin USA | 1997 | — |
| +1 | K071852 | Aap Aps System | Aap Implantate AG | 2007 | — |
| +2 | K120360 | Ortho Solutions Trauma Plates for Osteosysnthesis | Ortho Solutions Limited | 2012 | — |
| +3 | K202764 | Ortho Solutions Plating System | Ortho Solutions UK, Ltd. | 2020 | — |
| +2 | K221787 | Auxein's DHS/DCS Plate System | Auxein Medical Private Limited | 2023 | — |
| +3 | K210658 | Volition Plating System | Ortho Solutions UK, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 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 |
|---|---|---|---|
| * | — | Stratec (Synthes) DHS System Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071852 | Aap Aps System | 2007 | 4 |
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, K071852 (Aap Implantate AG, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Dynamic Hip Screw System devices are used in the treatment of femoral neck fractures in the pertrochanteric, intertrochanteric and high subtrochanteric regions of the femur, or in the treatment of combinations of these fractures. Pertrochanteric fractures occur from the greater to lesser trochanter. Intertrochanteric fractures occur within the trochanteric area. High subtrochanteric fractures occur immediately below the trochanter. The devices…
Read the full statement (101 words)
The Dynamic Hip Screw System devices are used in the treatment of femoral neck fractures in the pertrochanteric, intertrochanteric and high subtrochanteric regions of the femur, or in the treatment of combinations of these fractures.
Pertrochanteric fractures occur from the greater to lesser trochanter. Intertrochanteric fractures occur within the trochanteric area. High subtrochanteric fractures occur immediately below the trochanter.
The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral fracture.
The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.
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/K973231 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973231: The Corifix Dynamic Hip Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973231
Report an extraction error
Are you the manufacturer?
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