510(k) · Cleared
ClearedOrthoplan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Graphics, Inc. · HWT Template
Cleared on Feb 18, 1998 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 18, 1998
- Review
- 89 days
- Class
- Class I
- Product code
- HWT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWT? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All HWT devicesHWT Template: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWT
FDA has decided no HWT device since 2007.
Median 510(k) review, days · HWT
Too few HWT 510(k)s in any year since 2007 to give a median.
Recalls per year · HWT
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWT
2,216in 2025
MAUDE reports naming product code HWT, 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 | 0 |
| 2008 | 0 | — | 6 | 5 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 13 | 62 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 3 | 88 |
| 2014 | 0 | — | 1 | 78 |
| 2015 | 0 | — | 0 | 93 |
| 2016 | 0 | — | 0 | 444 |
| 2017 | 0 | — | 1 | 651 |
| 2018 | 0 | — | 0 | 714 |
| 2019 | 0 | — | 0 | 741 |
| 2020 | 0 | — | 0 | 938 |
| 2021 | 0 | — | 0 | 2,177 |
| 2022 | 0 | — | 0 | 2,096 |
| 2023 | 0 | — | 0 | 2,598 |
| 2024 | 0 | — | 0 | 2,416 |
| 2025 | 0 | — | 0 | 2,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the OrthoPlan software, to overlay the constructed images to aid surgeons in their planning of orthopaedic surgeries.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974406: Orthoplan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974406
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026