510(k) · Cleared
ClearedTS Fixture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 29, 2012 as substantially equivalent to K090237 (Hiossen, Inc., 2009) and 3 other predicates after a 143-day review. Its family tree reaches back 12 generations to 1990. 24 later devices descend from it.
- Decided
- Nov 29, 2012
- Review
- 143 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K894595 (1990). 46 ancestors in all. 24 later devices descend from it, 11 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- This deviceK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- Descendant · cites it directly · 10 of its ownK153521 IH Implant SystemSewonmedix, Inc. · 2016
- Descendant · cites it directly · 7 of its ownK172100 URIS OMNI SystemTruabutment, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK222778 Osstem Implant SystemOsstem Implant Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK242753 SD TL Implant SystemArum Dentistry Co., Ltd. · 2025
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 backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK103537 ET Iii SA Ultra Wide SystemHiossen, Inc. · 2011
- This deviceK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K153521IH Implant SystemSewonmedix, Inc. · 2016 · cites it directly10descendants
- K172100URIS OMNI SystemTruabutment, Inc. · 2018 · cites it directly7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 2 generations on6descendants
- K222778Osstem Implant SystemOsstem Implant Co., Ltd. · 2023 · cites it directly2descendants
- K242753SD TL Implant SystemArum Dentistry Co., Ltd. · 2025 · 2 generations on1descendant
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 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −2 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −1 | K103537 | ET Iii SA Ultra Wide System | Hiossen, Inc. | 2011 | — |
| 0 (this device) | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
| +1 | K153521 | IH Implant System | Sewonmedix, Inc. | 2016 | — |
| +1 | K172100 | URIS OMNI System | Truabutment, Inc. | 2018 | — |
| +2 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +1 | K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023 | — |
| +2 | K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K090237 | HG II Fixture SystemSummary page 1…Class HI DZE 3. Predicate Device: The HGII Fixture System, HIOSSEN Inc., Ltd, K090237 The ETTII SA Fixture System, HIOSSEN Inc., K101096 The GSIII System, Osstem Implant Co., Ltd, K09 1208 The ETIJI SA Ultra w… | 2009 |
| * | K101096 | HT Iii SA Fixture SystemSummary page 1…DZE 3. Predicate Device: The HGII Fixture System, HIOSSEN Inc., Ltd, K090237 The ETTII SA Fixture System, HIOSSEN Inc., K101096 The GSIII System, Osstem Implant Co., Ltd, K09 1208 The ETIJI SA Ultra wide Fixture, HIOSSEN Inc., K103537 4. Description:… | 2010 |
| * | K091208 | GS Iii SystemSummary page 1…redicate Device: The HGII Fixture System, HIOSSEN Inc., Ltd, K090237 The ETTII SA Fixture System, HIOSSEN Inc., K101096 The GSIII System, Osstem Implant Co., Ltd, K09 1208 The ETIJI SA Ultra wide Fixture, HIOSSEN Inc., K103537 4. Description: The TS Fixture System is a dental implant made of ti… | 2010 |
| * | K103537 | ET Iii SA Ultra Wide SystemSummary page 1…Ltd, K090237 The ETTII SA Fixture System, HIOSSEN Inc., K101096 The GSIII System, Osstem Implant Co., Ltd, K09 1208 The ETIJI SA Ultra wide Fixture, HIOSSEN Inc., K103537 4. Description: The TS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bo… | 2011 |
What descends from it? (24)
See all 2411 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153521 | IH Implant System | 2016 | 10 |
| K172100 | URIS OMNI System | 2018 | 7 |
| K222778 | Osstem Implant System | 2023 | 2 |
| K232268 | STERI-OSS Implant System | 2024 | 1 |
| K212702 | IM/ST Fixture System | 2022 | 1 |
| K142813 | Biogensis Implant System-Kisses | 2015 | 1 |
| K222738 | Point implant system | 2023 | 0 |
| K192274 | BV Dental Implant System | 2020 | 0 |
| K172630 | Kisses Plus Implant System | 2018 | 0 |
| K163088 | TSIII BA Fixture | 2017 | 0 |
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 22 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 46 ancestors have a recall of any class.
- Of its descendants, K153521 (Sewonmedix, Inc., 2016) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K090237.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The TS Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
TS Fixture System is compatible with abutment in the ET/SS Implant System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121995: TS Fixture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121995
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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