510(k) · Cleared
ClearedHigh Tibial Osteotomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newclip Technics · HRS Plate, Fixation, Bone
Cleared on Jan 30, 2015 as substantially equivalent to K032187 (Arthrex, Inc., 2003) and 2 other predicates after a 233-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- Jan 30, 2015
- Review
- 233 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000684 (2000). 17 ancestors in all, the oldest K890939 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 1 generation backK063095 Humerus Locking Plating SystemNewclip Technics · 2006
- This deviceK141548 High Tibial Osteotomy SystemNewclip Technics · 2015
- Descendant · cites it directly · 1 of its ownK173746 Activmotion RangeNewclip Technics · 2018
- Descendant · 2 generations on · 0 of its ownK241539 Activmotion SNewclip Technics · 2024
- Descendant · cites it directly · 0 of its ownK213214 Xpert WristNewclip Technics · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −2 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −1 | K063095 | Humerus Locking Plating System | Newclip Technics | 2006 | — |
| 0 (this device) | K141548 | High Tibial Osteotomy System | Newclip Technics | 2015 | — |
| +1 | K173746 | Activmotion Range | Newclip Technics | 2018 | — |
| +2 | K241539 | Activmotion S | Newclip Technics | 2024 | — |
| +1 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K032187 | Anthrex Titanium Opening Wedge Osteotomy SystemSummary page 4…redicate or legally marketed devices which are substantially equivalent: x The Arthrex Titanium Opening Wedge Osteotomy System of Arthrex, Inc. (K032187), x The Surfix® Knee Osteotomy System of Surfix Technologies S.A. (K041601), x The Humerus Locking Plat… | 2003 |
| * | K041601 | Surfix Knee Osteotomy SystemSummary page 4…Arthrex Titanium Opening Wedge Osteotomy System of Arthrex, Inc. (K032187), x The Surfix® Knee Osteotomy System of Surfix Technologies S.A. (K041601), x The Humerus Locking Plating System of Newclip Technics (K063095).… | 2004 |
| * | K063095 | Humerus Locking Plating SystemSummary page 4…(K032187), x The Surfix® Knee Osteotomy System of Surfix Technologies S.A. (K041601), x The Humerus Locking Plating System of Newclip Technics (K063095). S… | 2006 |
What descends from it? (3)
2 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 15 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 6 of the 17 ancestors have a recall of any class.
- Of its descendants, K173746 (Newclip Technics, 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K032187.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 High Tibial Osteotomy System is indicated for fixation of high tibial osteotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141548: High Tibial Osteotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141548
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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