510(k) · Cleared
ClearedLOCATOR RTx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zest Anchors, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 24, 2015 as substantially equivalent to K072878 (Zest Anchors, Inc., 2007) and 1 other predicate after a 168-day review. Its family tree reaches back 12 generations to 1990. 42 later devices descend from it.
- Decided
- Jul 24, 2015
- Review
- 168 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K894595 (1990). 151 ancestors in all, the oldest K781060 (1978). 42 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- Descendant · cites it directly · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · cites it directly · 8 of its ownK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
- Descendant · 2 generations on · 7 of its ownK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
- Descendant · 2 generations on · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK120414 Osseospeed PlusAstra Tech AB · 2012
- This deviceK150295 LOCATOR RTxZest Anchors, Inc. · 2015
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · cites it directly30descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 2 generations on8descendants
- K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016 · cites it directly8descendants
- K213391High Retention Attachment SystemZest Anchors, LLC · 2022 · 2 generations on7descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| 0 (this device) | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| +1 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +1 | K151789 | LOCATOR F-Tx Attachment System | Zest Anchors, LLC | 2016 | — |
| +2 | K213391 | High Retention Attachment System | Zest Anchors, LLC | 2022 | — |
| +2 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K072878 | Modification to: Locator Implant AnchorSummary page 6…nd it is a nylon or PEEK liner overdenture system with varying cuff heights. Primary predicate: Zest Anchors, Inc., Modification to Locator Implant Anchor cleared under K072878. Reference Device: Astra Tech AB, OsseoSpeed Plus cleared under K120414. 510(k) Number Implant S… | 2007 |
| * | K120414 | Osseospeed PlusSummary page 6…hts. Primary predicate: Zest Anchors, Inc., Modification to Locator Implant Anchor cleared under K072878. Reference Device: Astra Tech AB, OsseoSpeed Plus cleared under K120414. 510(k) Number Implant System Compatibility K063341 Biomet… | 2012 |
What descends from it? (42)
See all 423 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 151 ancestors have a recall of any class.
- Of its descendants, K182091 (Osstem Implant Co., Ltd., 2019) has gone furthest, with 30 descendants of its own.
- 6 other devices also cite its predicate K072878.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
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)…
Read the full statement (173 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150295: LOCATOR RTx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150295
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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