510(k) · Cleared
ClearedAesculap Implant Systems High Tibial Osteotomy Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, Inc. · HRS Plate, Fixation, Bone
Cleared on Sep 4, 2008 as substantially equivalent to K973812 (Arthrex, Inc., 1998) after a 150-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Sep 4, 2008
- Review
- 150 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973812 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK973812 Arthrex Puddu Osteotomy SystemArthrex, Inc. · 1998
- This deviceK080992 Aesculap Implant Systems High Tibial Osteotomy Plating SystemAesculap Implant Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK102505 Hto Plating SystemAesculap Implant Systems, LLC · 2010
Most influential descendants
Showing 1 of 1 · See all- K102505Hto Plating SystemAesculap Implant Systems, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973812 | Arthrex Puddu Osteotomy System | Arthrex, Inc. | 1998 | — |
| 0 (this device) | K080992 | Aesculap Implant Systems High Tibial Osteotomy Plating System | Aesculap Implant Systems, Inc. | 2008 | — |
| +1 | K102505 | Hto Plating System | Aesculap Implant Systems, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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? (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 |
|---|---|---|---|
| * | K973812 | Arthrex Puddu Osteotomy SystemSummary page 1…88.3040 SUBSTANTIAL EQUIVALENCE Aesculap Implant Systems, Inc., believes that the HTO Plating System is substantially equivalent to the Arthrex Puddu Osteotomny System (K973812). DEVICE DESCRIPTION The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of a single tapered… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102505 | Hto Plating System | 2010 | 0 |
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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080992: Aesculap Implant Systems High Tibial Osteotomy Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080992
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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