510(k) · Cleared
ClearedOrthofix Contours Proimal Humeral Plate (PHP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Sep 20, 2012 as substantially equivalent to K062920 (Orthofix Srl, 2006) after a 30-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Sep 20, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062920 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062920 Orthofix Titanium Humeral Plating System LSPOrthofix Srl · 2006
- This deviceK122541 Orthofix Contours Proimal Humeral Plate (PHP)Orthofix Srl · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062920 | Orthofix Titanium Humeral Plating System LSP | Orthofix Srl | 2006 | — |
| 0 (this device) | K122541 | Orthofix Contours Proimal Humeral Plate (PHP) | Orthofix Srl | 2012 | — |
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 KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062920 | Orthofix Titanium Humeral Plating System LSPSummary page 1…3. Predicate Device: The Orthofix Contours Proximal Humeral Plate (PHP) is substantially equivalent to the Orthofix Titanium Humeral Plating System, 'LSP", K062920 4. Intended Use: The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122541: Orthofix Contours Proimal Humeral Plate (PHP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122541
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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