510(k) · Cleared
ClearedHipXpert 3D Display and Anchoring Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Planning Associates, Inc. · OSF Patient Specific Manual Orthopedic Stereotaxic System
Cleared on Jan 28, 2021 as substantially equivalent to K093491 (Surgical Planning Associates, 2010) after a 345-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.
- Decided
- Jan 28, 2021
- Review
- 345 days
- Class
- Class II
- Product code
- OSF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093491 (2010). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK093491 Hip Sextant Instrument SystemSurgical Planning Associates · 2010
- This deviceK200384 HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK233315 HipXpert and HipInsight SystemSurgical Planning Associates, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233315HipXpert and HipInsight SystemSurgical Planning Associates, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093491 | Hip Sextant Instrument System | Surgical Planning Associates | 2010 | — |
| 0 (this device) | K200384 | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc. | 2021 | — |
| +1 | K233315 | HipXpert and HipInsight System | Surgical Planning Associates, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233315 | HipXpert and HipInsight System | 2024 | 0 |
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.
- Of its descendants, K233315 (Surgical Planning Associates, Inc., 2024) has gone furthest, with 0 descendants 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. 2021, 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 HipXpert system is a manual surgical instrument and associated software application designed for use in planning surgery and aligning the acetabular components during hip arthroplasty procedures.
The HipXpert 3D Display and Anchoring application with the HoloLens2 is indicated for visual alignment of an acetabular cup impactor during hip arthroplasty when pin-based fixation of the HipXpert tool is utilized.
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/K200384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200384: HipXpert 3D Display and Anchoring Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200384
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026