510(k) · Cleared
ClearedOpening/Closing Wedge Ostetomy Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HRS Plate, Fixation, Bone
Cleared on Mar 18, 2002 after an 89-day review. The FDA summary names no predicate by number. 13 later devices descend from it.
- Decided
- Mar 18, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK014155 Opening/Closing Wedge Ostetomy PlatesArthrex, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK150456 Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK041601 Surfix Knee Osteotomy SystemSurfix Technologies · 2004
- Descendant · 2 generations on · 3 of its ownK141548 High Tibial Osteotomy SystemNewclip Technics · 2015
- Descendant · 2 generations on · 1 of its ownK250920 Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK222267 Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K150456Arthrex Plates, Screws, and StaplesArthrex, Inc. · 2015 · cites it directly6descendants
- K041601Surfix Knee Osteotomy SystemSurfix Technologies · 2004 · cites it directly5descendants
- K141548High Tibial Osteotomy SystemNewclip Technics · 2015 · 2 generations on3descendants
- K250920Arthrex Spine Compression FT ScrewArthrex, Inc. · 2025 · 2 generations on1descendant
- K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014155 | Opening/Closing Wedge Ostetomy Plates | Arthrex, Inc. | 2002 | — |
| +1 | K150456 | Arthrex Plates, Screws, and Staples | Arthrex, Inc. | 2015 | — |
| +1 | K041601 | Surfix Knee Osteotomy System | Surfix Technologies | 2004 | — |
| +2 | K141548 | High Tibial Osteotomy System | Newclip Technics | 2015 | — |
| +2 | K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025 | — |
| +2 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | Arthrex, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (13)
See all 132 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?
- Of its descendants, K150456 (Arthrex, Inc., 2015) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar…
Read the full statement (114 words)
The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.
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/K014155 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014155: Opening/Closing Wedge Ostetomy Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014155
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026