510(k) · Cleared
ClearedAnchor plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomaterials Korea, Inc. · OAT Implant, Endosseous, Orthodontic
Cleared on Aug 30, 2018 as substantially equivalent to K091051 (Tita-Link, 2009) after a 279-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Aug 30, 2018
- Review
- 279 days
- Class
- Class II
- Product code
- OAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954385 (1996). 24 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
- 4 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
- 3 generations backK022185 Universal CMF SystemStryker Instruments · 2002
- 2 generations backK041651 Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger · 2004
- 1 generation backK091051 Bollard Miniplate Skeletal Anchorage SystemTita-Link · 2009
- This deviceK173623 Anchor plateBiomaterials Korea, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −5 | K981890 | Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates | Synthes (Usa) | 1998 | — |
| −4 | K993862 | Modus Sagittal Split Plate | The Straumann Co. | 1999 | — |
| −3 | K022185 | Universal CMF System | Stryker Instruments | 2002 | — |
| −2 | K041651 | Stryker Leibinger Skeletal Anchoring System | Stryker Leibinger | 2004 | — |
| −1 | K091051 | Bollard Miniplate Skeletal Anchorage System | Tita-Link | 2009 | — |
| 0 (this device) | K173623 | Anchor plate | Biomaterials Korea, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K091051 | Bollard Miniplate Skeletal Anchorage SystemSummary page 4…Product Code: OAT 3. Predicated Device ž Primary Predicate Device BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM, TITA-LINK, K091051 ž Reference Predicate Devices KLS MARTIN ORTHO ANCHORAGE SYSTEM, KLS-MARTIN L.P., K040891 SYNTHES ORT… | 2009 |
| † | K040891 | KLS Martin Ortho Anchorage System (Plates) | 2004 |
| † | K063473 | Synthes Orthodontic Bone Anchor System | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 24 ancestors have a recall of any class.
How does its category compare?
All OAT devicesOAT Implant, Endosseous, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
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/K173623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173623: Anchor plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173623
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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