# K150780: Acetabular Cup Orientation System

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Oct 27, 2015 after 216 days
- Product code: PLW (Acetabular Cup Orientation System)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K905070 (1991). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111863: Signature Planner,Signature Guides, Materialise NV (2012) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K150780
Methodology: https://510kreport.com/methodology