510(k) · Cleared
ClearedOrthodoc Preoperative Planner Model 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Surgical Systems, Inc. · HWT Template
Cleared on Jan 17, 1997 after a 332-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 17, 1997
- Review
- 332 days
- Class
- Class I
- Product code
- HWT
- Recalls
- None
- 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.
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? (2)
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 |
|---|---|---|---|
| * | — | Depuy AML templates Named without a submission number | |
| * | — | Howmedica Osteolock HA templates 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)
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 ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import compurted tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.
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/K960685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960685: Orthodoc Preoperative Planner Model 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960685
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)
- Page last updated Nov 3, 2026