510(k) · Cleared
ClearedHip Sextant Instrument System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Planning Associates · OSF Patient Specific Manual Orthopedic Stereotaxic System
Cleared on Dec 9, 2010 after a 394-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Dec 9, 2010
- Review
- 394 days
- Class
- Class II
- Product code
- OSF
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK093491 Hip Sextant Instrument SystemSurgical Planning Associates · 2010
- Descendant · cites it directly · 1 of its ownK200384 HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK233315 HipXpert and HipInsight SystemSurgical Planning Associates, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093491 | Hip Sextant Instrument System | Surgical Planning Associates | 2010 | — |
| +1 | K200384 | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc. | 2021 | — |
| +2 | K233315 | HipXpert and HipInsight System | Surgical Planning Associates, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 OSF? 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 OSF device
- #1 K233315 HipXpert and HipInsight Systemscore 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Wright Medical - Acetabular Alignment Guide Named without a submission number | |
| * | — | Depuy - Pinnacle Cup System Named without a submission number | |
| * | — | Stryker - Acetabular Alignment Guide Named without a submission number | |
| * | — | Aufranc Universal Cup Alignment Guide Named without a submission number | |
| * | — | Protractors Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200384 | HipXpert 3D Display and Anchoring Application | 2021 | 1 |
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, K200384 (Surgical Planning Associates, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OSF devicesOSF Patient Specific Manual Orthopedic Stereotaxic System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OSF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OSF
Too few OSF 510(k)s in any year since 2007 to give a median.
Recalls per year · OSF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSF
No MAUDE report names OSF since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093491: Hip Sextant Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093491
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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