510(k) · Cleared
ClearedPrecimed Hip Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precimed, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 28, 2003 after a 70-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jan 28, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK023851 Precimed Hip Screw SystemPrecimed, Inc. · 2003
- 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) | K023851 | Precimed Hip Screw System | Precimed, Inc. | 2003 | — |
| +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 21.3 · 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? (3)
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 |
|---|---|---|---|
| * | — | AMBI Hip Screw System (S &N Richards) Named without a submission number | |
| * | — | HDS / DCS Dynamic Hip & Condylar Screw System (Synthes) Named without a submission number | |
| * | — | Syntec-Taichung DHS / DCS Plate System (Syntec-Taichung Medical Instrument Co.) 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 Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures,
subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital
epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and
distal femur fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023851: Precimed Hip Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023851
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