# K150295: LOCATOR RTx

- Pathway: 510(k) (Traditional)
- Applicant: Zest Anchors, Inc.
- Decided: Jul 24, 2015 after 168 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K894595 (1990). 151 ancestors in all.
42 later devices descend from it; 3 cite it directly.
0 of 194 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072878: Modification to: Locator Implant Anchor, Zest Anchors, Inc. (2007) Summary page 6.
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 6.

## Most influential descendants
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K151789: LOCATOR F-Tx Attachment System (2016), 8 descendants of its own
- K213391: High Retention Attachment System (2022), 7 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own

## Indications for use
The LOCATOR® RTx Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. LOCATOR® RTx Attachment System is compatible with the following implant systems. Implant Manufacturer: System: BioHorizons Internal Hex (3.0, 3.5, 4.5, 5.7 mm) External Hex (3.5, 4.0, 5.0 mm) Biomet 3i Certain Internal (3.4, 4.1, 5.0, 6.0 mm) External Hex (3.4, 4.1, 5.0, 6.0 mm) Camlog Camlog and Conelog; (3.3, 3.8, 4.3, 5.0 mm) iSy (3.8, 4.4, 5.0 mm) Dentsply Ankylos (3.5, 4.5, 5.5, 7.0 mm) XiVE/FRIALIT-2 (3.4, 3.8, 4.5, 5.5 mm) Astra Tech OsseoSpeed EV (3.6, 4.2, 4.8 mm) MIS Implants Internal Hex (3.75, 4.5 mm) Nobel Biocare Replace: Internal (3.5, 4.3, 5.0, 6.0 mm), NobelActive: Internal Conical (3.0, 3.5, 4.3, 5.0 mm), Brånemark: External Hex (3.3, 3.75, 4.0, 5.0 mm) Straumann Tissue Level (3.5, 4.8, 6.5 mm) Bone Level (3.3, 4.1, 4.8 mm) Zimmer Tapered Screw Vent: Internal Hex (3.5, 4.5, 5.7 mm) Spline (3.25, 4.0, 5.0 mm) Swiss Plus:Internal Octagon (3.8, 4.8 mm)

Source page: https://510kreport.com/device/K150295
Methodology: https://510kreport.com/methodology