510(k) · Cleared
ClearedEVOS Large Fragment Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRS Plate, Fixation, Bone
Cleared on Jan 27, 2021 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 5 other predicates after a 69-day review. Its family tree reaches back 11 generations to 1996. 3 later devices descend from it.
- Decided
- Jan 27, 2021
- Review
- 69 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K962616 (1996). 62 ancestors in all, the oldest K842977 (1984). 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 2 generations backK162078 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2016 · Recalled
- 1 generation backK201918 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2020 · Recalled
- This deviceK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233396 Cannulated Screw SystemSmith & Nephew, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 3 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 2 generations backK162078 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2016 · Recalled
- 1 generation backK201918 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2020 · Recalled
- This deviceK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · cites it directly2descendants
- K252019CurvaFix Low Profile SystemCurvafix, Inc. · 2025 · 2 generations on0descendants
- K233396Cannulated Screw SystemSmith & Nephew, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −3 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −2 | K162078 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | 2016 | 1 |
| −1 | K201918 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | 2020 | 4 |
| 0 (this device) | K203405 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | 2021 | — |
| +1 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025 | — |
| +2 | K233396 | Cannulated Screw System | Smith & Nephew, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (6)
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 |
|---|---|---|---|
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 4…Nephew Locking Bone Smith & Nephew, December 10, Plate System (PERI-LOC) Primary K033669 Inc. 2003 Predicate… | 2003 |
| * | K031162 | Smith & Nephew Orthopaedic Cabling SystemSummary page 4…2003 Predicate Smith & Nephew Orthopaedic Smith & Nephew, Inc. K031162 May 1, 2003 Cabling System (ACCORD) EVOS Small Fragment Plating Smith &… | 2003 |
| * | K162078 | EVOS Small Fragment Plating SystemSummary page 4…y 1, 2003 Cabling System (ACCORD) EVOS Small Fragment Plating Smith & Nephew, Inc. K162078 November 18, 2016 System Straight Plates and Screws PERI-LOC Proximal Fe… | 2016 |
| * | K072818 | Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSummary page 4…System Straight Plates and Screws PERI-LOC Proximal Femur Locking Smith & Nephew, Inc. Bone Plates, Bone Screws and K072818 November 19, 2007 Cable Accessories PERI-LOC Periarticular Locked Smith… | 2007 |
| * | K092015 | Peri-Loc Periarticular Locked Plating SystemSummary page 4…mber 19, 2007 Cable Accessories PERI-LOC Periarticular Locked Smith & Nephew, Inc. Plating System for Lower & Upper K092015 July 30, 2009 Extremity EVOS Large Fragment Plating… | 2009 |
| * | K201918 | EVOS Large Fragment Plating SystemSummary page 4…Extremity EVOS Large Fragment Plating November 16, Smith & Nephew, Inc. K201918 System 2020… | 2020 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP… | 2022 | 2 |
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 25 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 15 of the 62 ancestors have a recall of any class.
- Of its descendants, K213126 (Smith & Nephew, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 27 other devices also cite its predicate K033669.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.
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/K203405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203405: EVOS Large Fragment 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/K203405
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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