510(k) · Cleared
ClearedEVOS Patella Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew · HRS Plate, Fixation, Bone
Cleared on Sep 3, 2024 as substantially equivalent to K140814 (Smith & Nephew, Inc., 2014) and 2 other predicates after a 196-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Sep 3, 2024
- Review
- 196 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K962616 (1996). 190 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK143702 Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015
- 2 generations backK201677 Arthrex Mesh PlatesArthrex, Inc. · 2020
- 1 generation backK203834 Arthrex Patella SuturePlatesArthrex, Inc. · 2021
- This deviceK240487 EVOS Patella PlatesSmith & Nephew · 2024
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- 4 generations backK142442 Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc. · 2014 · Recalled
- 3 generations backK143702 Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc. · 2015
- 2 generations backK201677 Arthrex Mesh PlatesArthrex, Inc. · 2020
- 1 generation backK203834 Arthrex Patella SuturePlatesArthrex, Inc. · 2021
- This deviceK240487 EVOS Patella PlatesSmith & Nephew · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| −4 | K142442 | Magna-FX and Mini Magna-FX Cannulated Screw Fixation System | Zimmer, Inc. | 2014 | 3 |
| −3 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | Arthrex, Inc. | 2015 | — |
| −2 | K201677 | Arthrex Mesh Plates | Arthrex, Inc. | 2020 | — |
| −1 | K203834 | Arthrex Patella SuturePlates | Arthrex, Inc. | 2021 | — |
| 0 (this device) | K240487 | EVOS Patella Plates | Smith & Nephew | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 16 | 0 |
| 2001 | 18 | 0 |
| 2002 | 10 | 0 |
| 2003 | 7 | 0 |
| 2004 | 11 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K140814 | Evos Mini-Fragment Plating SystemSummary page 5…3030 Product Code(s) HRS, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K140814 EVOS Mini-Fragment Plating System HRS K210408 Depuy Synthes Variable Angle Locking Patella Plating System HRS K203834 Arthrex Pat… | 2014 |
| * | K210408 | DePuy Synthes Variable Angle Locking Patella Plating SystemSummary page 5…ted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K140814 EVOS Mini-Fragment Plating System HRS K210408 Depuy Synthes Variable Angle Locking Patella Plating System HRS K203834 Arthrex Patella Sutureplates HRS | Device Description Su… | 2021 |
| * | K203834 | Arthrex Patella SuturePlatesSummary page 5…me (Primary Predicate is listed first) Product Code K140814 EVOS Mini-Fragment Plating System HRS K210408 Depuy Synthes Variable Angle Locking Patella Plating System HRS K203834 Arthrex Patella Sutureplates HRS | Device Description Summary 21 CFR 807.92(a)(4) The subject EVOS Patella Plates are an extens… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 36 of the 190 ancestors have a recall of any class.
- 10 other devices also cite its predicate K140814.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 EVOS Mini Plating System, excluding EVOS Patella Plates, is indicated for patients 12 — 21 and those over 21 years of age, as well as patients with osteopenic bone. The Smith & Nephew EVOS Mini Plating System is indicated for fracture fixation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The EVOS Patella Plates are indicated for the fixation and stabilization of patellar fractures for patients over 21 years of age.
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/K240487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240487: EVOS Patella Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240487
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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