510(k) · Cleared
ClearedHipXpert and HipInsight System
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 Aug 8, 2024 as substantially equivalent to K200384 (Surgical Planning Associates, Inc., 2021) after a 314-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Aug 8, 2024
- Review
- 314 days
- Class
- Class II
- Product code
- OSF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093491 (2010). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K093491 | Hip Sextant Instrument System | Surgical Planning Associates | 2010 | — |
| −1 | K200384 | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc. | 2021 | — |
| 0 (this device) | K233315 | HipXpert and HipInsight System | Surgical Planning Associates, Inc. | 2024 | — |
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 K200384 HipXpert 3D Display and Anchoring Applicationscore 3.8 · 1 generation · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200384 | HipXpert 3D Display and Anchoring ApplicationSummary page 4…4560 Product Code(s) OSF, SBF I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K200384 HipXpert System OSF Device Description Summary 21 CFR 807.92(a)(4) anterior pelvic plane. The Hiplnsight System was cleared in… | 2021 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 10.1 years on median.
- None of the 2 ancestors has a recall.
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. 2024, 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 Hiplnsight system with the HoloLens2 is indicated for visualization of the HipXpert surgical plan
and alignment of acetabular implants and instrumentation during hip arthroplasty when pin-based
fixation of the HipXpert tools 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/K233315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233315: HipXpert and HipInsight System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233315
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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