510(k) · Cleared
ClearedAce Surigical Tru-Fix Implant System, Model 454-180X-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Surgical Supply Co., Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 14, 2008 as substantially equivalent to K061397 (Ace Surgical Supply Co., Inc., 2006) and 1 other predicate after a 34-day review. Its family tree reaches back 5 generations to 1990. 5 later devices descend from it.
- Decided
- Feb 14, 2008
- Review
- 34 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894844 (1990). 19 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK973353 Bonding BaseStraumann USA · 1997
- 3 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 2 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 1 generation backK061397 Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM…Ace Surgical Supply Co., Inc. · 2006
- This deviceK080074 Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008
- Descendant · cites it directly · 2 of its ownK100779 Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK182881 Bone Screw, Bone TackOsstem Implant Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK110259 Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK251569 Bone ScrewOsstem Implant Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK120271 Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010 · cites it directly2descendants
- K182881Bone Screw, Bone TackOsstem Implant Co., Ltd. · 2019 · cites it directly1descendant
- K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly1descendant
- K251569Bone ScrewOsstem Implant Co., Ltd. · 2025 · 2 generations on0descendants
- K120271Artisan Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −3 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −2 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −1 | K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model… | Ace Surgical Supply Co., Inc. | 2006 | — |
| 0 (this device) | K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-XX | Ace Surgical Supply Co., Inc. | 2008 | — |
| +1 | K100779 | Sustain Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +1 | K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019 | — |
| +1 | K110259 | Architex Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +2 | K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025 | — |
| +2 | K120271 | Artisan Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…Summary page 1…product code DZE icate device ACE Surgical Miniboneplate system, K951392 ACE Surgical Orthodontic Bone Screw System, K061 397 aon for submission: Not previously marketed in the USA recDescription and Materials:… | 2006 |
| * | K951392 | Miniboneplate SystemSummary page 1…ous Implant Screw asiictio Nme: Implant, Endlosseous, Root form, product code DZE icate device ACE Surgical Miniboneplate system, K951392 ACE Surgical Orthodontic Bone Screw System, K061 397 aon for submission: Not previ… | 1995 |
What descends from it? (5)
3 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 18 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K100779 (Medtronic Sofamor Danek USA, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080074: Ace Surigical Tru-Fix Implant System, Model 454-180X-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080074
Report an extraction error
Are you the manufacturer?
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