510(k) · Cleared
ClearedAscension Ankle Fusion Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 16, 2010 as substantially equivalent to K061940 (Synthes (Usa), 2006) and 2 other predicates after a 146-day review. Its family tree reaches back 5 generations to 2000. 56 later devices descend from it.
- Decided
- Jun 16, 2010
- Review
- 146 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000684 (2000). 21 ancestors in all, the oldest K890939 (1989). 56 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 4 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 3 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 2 generations backK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
- 1 generation backK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
- This deviceK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010
- Descendant · cites it directly · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 2 generations on · 12 of its ownK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017
- Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · 3 generations on · 9 of its ownK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · cites it directly53descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
- K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017 · 2 generations on12descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
- K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −4 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −3 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −2 | K033639 | Acumed Lower Extremity Congruent Plate System | Acumed, LLC | 2004 | 10 |
| −1 | K073375 | Newdeal Tibiaxys System | Newdeal Sas | 2008 | 2 |
| 0 (this device) | K100176 | Ascension Ankle Fusion Plate System | Ascension Orthopedics, Inc. | 2010 | — |
| +1 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
| +2 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +2 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | 2017 | — |
| +3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +3 | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 1 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 7 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K061940 | Synthes LCP Ankle Arthrodesis PlatesSummary page 1…metallic bone fixation appliances and accessories PRODUCT CODE: HIRS PANEL: Orthopedic PREDICATE DEVICES: K061940 - Synthes LOP Ankle Arthrodesis Plates' K060473 - Integra Advansys Lateral Tiblo-Talar-Calcaneal Plate K073375 - Integra Tibiaxys… | 2006 |
| * | K060473 | TTC PlateSummary page 1…and accessories PRODUCT CODE: HIRS PANEL: Orthopedic PREDICATE DEVICES: K061940 - Synthes LOP Ankle Arthrodesis Plates' K060473 - Integra Advansys Lateral Tiblo-Talar-Calcaneal Plate K073375 - Integra Tibiaxys DEVICE DESCRIPTION: The Ascension® Ankle Fusio… | 2006 |
| * | K073375 | Newdeal Tibiaxys SystemSummary page 1…Orthopedic PREDICATE DEVICES: K061940 - Synthes LOP Ankle Arthrodesis Plates' K060473 - Integra Advansys Lateral Tiblo-Talar-Calcaneal Plate K073375 - Integra Tibiaxys DEVICE DESCRIPTION: The Ascension® Ankle Fusion Plate System consists of two anterior tibia-talus and a later… | 2008 |
What descends from it? (56)
See all 562 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 10 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K121425 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 53 descendants of its own.
- 3 other devices also cite its predicate K061940.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Ascension Ankle Fusion Plate System is intended for the following:
>Arthrodesis of the ankle joint and tibia
Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100176: Ascension Ankle Fusion Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100176
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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