510(k) · Cleared
ClearedTruAbutment DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truabutment · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 25, 2017 as substantially equivalent to K152559 (Truabutment, 2016) after a 118-day review. Its family tree reaches back 13 generations to 1990. 17 later devices descend from it.
- Decided
- May 25, 2017
- Review
- 118 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894595 (1990). 30 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 2 generations backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- 1 generation backK152559 TruAbutment DSTruabutment · 2016
- This deviceK170259 TruAbutment DSTruabutment · 2017
- Descendant · cites it directly · 8 of its ownK172304 TruAbutment DSTruabutment, Inc. · 2018
- Descendant · 2 generations on · 7 of its ownK183106 TruAbutment DSTruabutment, Inc. · 2020
- Descendant · cites it directly · 6 of its ownK201197 TruAbutment DS, TruBase STruabutment, Inc. · 2021
- Descendant · 3 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK202579 TruAbutment DS, TruBaseTruabutment, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 9 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 8 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 7 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 6 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 3 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 2 generations backK123627 ET Smartfit AbutmentHiossen, Inc. · 2013
- 1 generation backK152559 TruAbutment DSTruabutment · 2016
- This deviceK170259 TruAbutment DSTruabutment · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K172304TruAbutment DSTruabutment, Inc. · 2018 · cites it directly8descendants
- K183106TruAbutment DSTruabutment, Inc. · 2020 · 2 generations on7descendants
- K201197TruAbutment DS, TruBase STruabutment, Inc. · 2021 · cites it directly6descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 3 generations on6descendants
- K202579TruAbutment DS, TruBaseTruabutment, Inc. · 2021 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −9 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −8 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −7 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −6 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −3 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −2 | K123627 | ET Smartfit Abutment | Hiossen, Inc. | 2013 | — |
| −1 | K152559 | TruAbutment DS | Truabutment | 2016 | — |
| 0 (this device) | K170259 | TruAbutment DS | Truabutment | 2017 | — |
| +1 | K172304 | TruAbutment DS | Truabutment, Inc. | 2018 | — |
| +2 | K183106 | TruAbutment DS | Truabutment, Inc. | 2020 | — |
| +1 | K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | 2021 | — |
| +3 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +2 | K202579 | TruAbutment DS, TruBase | Truabutment, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K152559 | TruAbutment DSSummary page 5…uate its substantial equivalence according to the following standards. • Fatigue Test according to ISO 14801:2007 Below tests were performed for predicate device, K152559 and leveraged for the subject device: • End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and… | 2016 |
| † | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | 2015 |
What descends from it? (17)
See all 173 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 27 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 30 ancestors has a recall of any class.
- Of its descendants, K172304 (Truabutment, Inc., 2018) has gone furthest, with 8 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is
intended for use as an aid in prosthetic rehabilitation.
It is compatible with the following systems:
» Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm
All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a
TruAbutment-validated milling center for manufacture.
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/K170259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170259: TruAbutment DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170259
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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