510(k) · Cleared
ClearedSurfix Knee Osteotomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surfix Technologies · HRS Plate, Fixation, Bone
Cleared on Aug 27, 2004 as substantially equivalent to K023941 (Synthes (Usa), 2003) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it.
- Decided
- Aug 27, 2004
- Review
- 74 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K014155 (2002). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK014155 Opening/Closing Wedge Ostetomy PlatesArthrex, Inc. · 2002
- This deviceK041601 Surfix Knee Osteotomy SystemSurfix Technologies · 2004
- Descendant · cites it directly · 3 of its ownK141548 High Tibial Osteotomy SystemNewclip Technics · 2015
- Descendant · 2 generations on · 1 of its ownK173746 Activmotion RangeNewclip Technics · 2018
- Descendant · cites it directly · 0 of its ownK241539 Activmotion SNewclip Technics · 2024
- Descendant · cites it directly · 0 of its ownK212545 FlexitSystem Knee osteotomy systemNeosteo · 2022
- Descendant · 2 generations on · 0 of its ownK213214 Xpert WristNewclip Technics · 2021
Most influential descendants
Showing 5 of 5 · See all- K141548High Tibial Osteotomy SystemNewclip Technics · 2015 · cites it directly3descendants
- K173746Activmotion RangeNewclip Technics · 2018 · 2 generations on1descendant
- K241539Activmotion SNewclip Technics · 2024 · cites it directly0descendants
- K212545FlexitSystem Knee osteotomy systemNeosteo · 2022 · cites it directly0descendants
- K213214Xpert WristNewclip Technics · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014155 | Opening/Closing Wedge Ostetomy Plates | Arthrex, Inc. | 2002 | — |
| 0 (this device) | K041601 | Surfix Knee Osteotomy System | Surfix Technologies | 2004 | — |
| +1 | K141548 | High Tibial Osteotomy System | Newclip Technics | 2015 | — |
| +2 | K173746 | Activmotion Range | Newclip Technics | 2018 | — |
| +1 | K241539 | Activmotion S | Newclip Technics | 2024 | — |
| +1 | K212545 | FlexitSystem Knee osteotomy system | Neosteo | 2022 | — |
| +2 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K023941 | Synthes Tomofix Osteotomy SystemSummary page 2…FIX® Knee Osteotomy System is substantially equivalent to the Synthes TomoFixTM Osteotomy System (K023941) and the Arthrex Modified Osteotomy System (KO14155). COMPARISON OF The… | 2003 |
| * | K014155 | Opening/Closing Wedge Ostetomy Plates | 2002 |
What descends from it? (5)
3 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?
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 SURFIX® Knee Osteotomy System is indicated for knee osteotomies including high tibial osteotomy and femoral osteotomy in the cases of osteoarthritis of the medial tibiofemoral compartment with genu varum and lateral gonarthrosis on genu valgum. Examples Include:
* Fixation of opening wedge high tibial osteotomy,
* Fixation of fracture of the medial tibial plateau,
* Osteoarthritis of the medial tibiofemoral compartment with genu varum,
* Fixation of closing wedge high tibial osteotomy,
* Fixation of fracture of the lateral tibial plateau,
* Distal femoral varus osteotomy,
* Lateral gonarthrosis on genu valgum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041601: Surfix Knee Osteotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041601
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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