510(k) · Cleared
ClearedAcetabular Cup Orientation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise NV · PLW Acetabular Cup Orientation System
Cleared on Oct 27, 2015 as substantially equivalent to K111863 (Materialise NV, 2012) after a 216-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Oct 27, 2015
- Review
- 216 days
- Class
- Class II
- Product code
- PLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K905070 (1991). 25 ancestors in all, the oldest K861692 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 6 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 4 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 3 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 2 generations backK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- 1 generation backK111863 Signature Planner,Signature GuidesMaterialise NV · 2012
- This deviceK150780 Acetabular Cup Orientation SystemMaterialise NV · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −7 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −6 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −4 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −3 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −2 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| −1 | K111863 | Signature Planner,Signature Guides | Materialise NV | 2012 | — |
| 0 (this device) | K150780 | Acetabular Cup Orientation System | Materialise NV | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 PLW? 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? (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 |
|---|---|---|---|
| * | K111863 | Signature Planner,Signature GuidesSummary page 4…oprietary or model name Signature™ Personalized Patient Care System – Acetabular Guide System 510(k) number K111863 Decision date 15 June 2012 Product code JDI Manufacturer M… | 2012 |
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 24 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 25 ancestors have a recall of any class.
- 4 other devices also cite its predicate K111863.
How does its category compare?
All PLW devicesPLW Acetabular Cup Orientation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PLW
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PLW
Too few PLW 510(k)s in any year since 2007 to give a median.
Recalls per year · PLW
No recall names PLW since 2007.
Adverse event reports per year · PLW
2in 2022
MAUDE reports naming product code PLW, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Acetabular Cup Orientation (ACO) System is intended to be used as a surgical instrument to place a visual reference k-wire alignment pin to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty procedures. The system utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative CT imaging scans. The ACO System can be used with any 510(k) cleared, legally marketed…
Read the full statement (246 words)
The Acetabular Cup Orientation (ACO) System is intended to be used as a surgical instrument to place a visual reference k-wire alignment pin to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty procedures. The system utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative CT imaging scans.
The ACO System can be used with any 510(k) cleared, legally marketed, hemispherical acetabular cup implant system for primary Total Hip Arthroplasty (THA) and its respective compatible components, with the additional conditions listed below:
* Spherically shaped, symmetrical acetabular cups.
* Without protrusions for fixation such as spikes, threads, pegs, flanges or similar protruding elements.
* Cups with smooth outer surface or uniform coating.
* The central axis of the cup matches the direction of impaction; the inner and outer spherical surface of the cup have the same central axis.
* Cups have an apex hole to connect an impactor.
* Allowed deviations from a hemispherical cup shape (as long as the conditions stated above are fulfilled):
o Cups with a very slightly flattened dome.
o Cups with one or more holes for fixation with screws.
The ACO guides can only be used with hip systems that include reamers and impactors with straight handles.
The ACO guides can be used for posterior approach (Moore, also referred to as the ‘Southern approach’), postero-lateral approach (Marcy-Fletcher), lateral approach (Hardinge) and antero-lateral approach (Watson-Jones).
The ACO guides are intended for single use only.
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/K150780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150780: Acetabular Cup Orientation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150780
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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