510(k) · Cleared
ClearedHG II Fixture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hiossen, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 17, 2009 as substantially equivalent to K080744 (Osstem Implant Co., Ltd., 2008) after a 74-day review. Its family tree reaches back 8 generations to 1990. 38 later devices descend from it.
- Decided
- Apr 17, 2009
- Review
- 74 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894595 (1990). 19 ancestors in all. 38 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 4 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 3 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 2 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 1 generation backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- This deviceK090237 HG II Fixture SystemHiossen, Inc. · 2009
- Descendant · cites it directly · 24 of its ownK121995 TS Fixture SystemOsstem Implant Co., Ltd. · 2012
- Descendant · cites it directly · 14 of its ownK123471 Etii SA Fixture SystemHiossen, Inc. · 2013
- Descendant · 2 generations on · 13 of its ownK140934 Hiossen Implant SystemHiossen, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK153521 IH Implant SystemSewonmedix, Inc. · 2016
- Descendant · 3 generations on · 9 of its ownK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K121995TS Fixture SystemOsstem Implant Co., Ltd. · 2012 · cites it directly24descendants
- K123471Etii SA Fixture SystemHiossen, Inc. · 2013 · cites it directly14descendants
- K140934Hiossen Implant SystemHiossen, Inc. · 2014 · 2 generations on13descendants
- K153521IH Implant SystemSewonmedix, Inc. · 2016 · 2 generations on10descendants
- K151626ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −4 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −3 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −2 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −1 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K090237 | HG II Fixture System | Hiossen, Inc. | 2009 | — |
| +1 | K121995 | TS Fixture System | Osstem Implant Co., Ltd. | 2012 | — |
| +1 | K123471 | Etii SA Fixture System | Hiossen, Inc. | 2013 | — |
| +2 | K140934 | Hiossen Implant System | Hiossen, Inc. | 2014 | — |
| +2 | K153521 | IH Implant System | Sewonmedix, Inc. | 2016 | — |
| +3 | K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K080744 | HG II Fixture SystemSummary page 1…Class II DZE 3. Predicate Device: The HG H Fixture System, Osstem Implant Co., Ltd, K080744 4. Description: The HG II Fixture System is a dental implant made of titanium metal intended to be surgically placed… | 2008 |
What descends from it? (38)
See all 382 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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K121995 (Osstem Implant Co., Ltd., 2012) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K080744.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 HG TI 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 terminal or intermediate abutment support for fixed bridgework. The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090237: HG II 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/K090237
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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