510(k) · Cleared
Recalled · 2006VHS Pediatric Hip Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Abendschein, M.D. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Aug 15, 2001 after an 83-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Aug 15, 2001
- Review
- 83 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
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What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Pediatric Compression Hip Screw System (Smith & Nephew Richards) Named without a submission number | |
| * | — | Trauma Internal Fixation System (Smith & Nephew Inc.) Named without a submission number | |
| * | — | VHS Vari-Angle Compression Hip Screw System (Biomet) Named without a submission number | |
| * | — | Pediatric Osteotomy System (Howmedica) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 6, 2006 | Not classified | Z-0180-2007 | Other | VHS Plate and lag screw components did not assemble correctly intraoperatively. |
| Sep 6, 2006 | Not classified | Z-0181-2007 | Other | VHS Plate and lag screw components did not assemble correctly intraoperatively. |
No ancestor or descendant has a Class I recall.
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 VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows :
1. Congenital coxa vara.
Congenital dislocation of the hip
3. Subluxation or dislocation secondary to neurologic disorders,
such as cerebral palsy, myelomenigocele, poliomyelitis, etc.
Usually valgus-anteversion deformities.
4. Coxa plana ( Legg-Calve-Perthes disease )
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/K011603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011603: VHS Pediatric 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/K011603
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026