510(k) · Cleared
ClearedAce Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model 454-91001,454-91002 and 1.2/1.5MM X 6,8,10MM, M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Surgical Supply Co., Inc. · OAT Implant, Endosseous, Orthodontic
Cleared on Aug 16, 2006 as substantially equivalent to K951392 (Ace Surgical Supply Co., Inc., 1995) and 2 other predicates after an 89-day review. Its family tree reaches back 4 generations to 1990. 6 later devices descend from it.
- Decided
- Aug 16, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894844 (1990). 18 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 3 generations backK973353 Bonding BaseStraumann USA · 1997
- 2 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 1 generation backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- This deviceK061397 Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM…Ace Surgical Supply Co., Inc. · 2006
- Descendant · cites it directly · 5 of its ownK080074 Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK100779 Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK182881 Bone Screw, Bone TackOsstem Implant Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK110259 Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK251569 Bone ScrewOsstem Implant Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008 · cites it directly5descendants
- K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 2 generations on2descendants
- K182881Bone Screw, Bone TackOsstem Implant Co., Ltd. · 2019 · 2 generations on1descendant
- K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on1descendant
- K251569Bone ScrewOsstem Implant Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −3 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −2 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −1 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| 0 (this device) | K061397 | Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model… | Ace Surgical Supply Co., Inc. | 2006 | — |
| +1 | K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-XX | Ace Surgical Supply Co., Inc. | 2008 | — |
| +2 | K100779 | Sustain Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +2 | K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K110259 | Architex Space Maintenance System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +3 | K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 OAT? 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 OAT device
- #1 K260268 OrthoEasy Pal; OrthoEasy Pal Long Neckscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K951392 | Miniboneplate SystemSummary page 1…plant Screw Classification Name: Implant, Endosseous, Root form, product code DZE Predicate device: ACE Surgical Miniboneplate system, K951392 Reason for submission: Not previously marketed in the USA Device Description and Materials: The ACE Surgical Orthod… | 1995 |
| * | K033483 | KLS-Martin Ortho Anchorage SystemSummary page 1…): The ACE Surgical Orthodontic Bone Screw System is substantially equivalent to the: ACE Surgical Screw Miniboneplate System, K951392 KLS-Martin Ortho Anchorage System, K033483 Osteomed Orthodontic Screw System, K031936 Among the information and data presented in the 510(k) submission to support the subst… | 2004 |
| * | K031936 | Osteomed Orthodontic Screw SystemSummary page 1…System is substantially equivalent to the: ACE Surgical Screw Miniboneplate System, K951392 KLS-Martin Ortho Anchorage System, K033483 Osteomed Orthodontic Screw System, K031936 Among the information and data presented in the 510(k) submission to support the substantial equivalency of the ACE Surgical Orth… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080074 | Ace Surigical Tru-Fix Implant System, Model 454-180X-XX | 2008 | 5 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K080074 (Ace Surgical Supply Co., Inc., 2008) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K951392.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OAT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAT
224in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAT
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAT
5in 2025
MAUDE reports naming product code OAT, 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 | 6 | 104 | 2 | 2 |
| 2008 | 3 | 94 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 152 | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 28 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 289 | 0 | 38 |
| 2021 | 4 | 224 | 0 | 68 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 1 | — | 0 | 78 |
| 2024 | 2 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ACE Surgical Orthodontic Bone Screw System is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.
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/K061397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061397: Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model 454-91001,454-91002 and 1.2/1.5MM X 6,8,10MM, M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061397
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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