510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

EVOS Large Fragment Plating System

K201918510(k) TraditionalCleared Nov 16, 2020129-day reviewClass II21 CFR 888.3030Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · HRS Plate, Fixation, Bone

Cleared on Nov 16, 2020 as substantially equivalent to K033669 (Smith & Nephew, Inc., 2003) and 5 other predicates after a 129-day review. Its family tree reaches back 10 generations to 1996. 4 later devices descend from it. It has been recalled 4 times.

Decided
Nov 16, 2020
Review
129 days
Class
Class II
Product code
HRS
Recalls
4
Predicates
6

Its longest line of descent runs back 10 generations to K962616 (1996). 42 ancestors in all, the oldest K890939 (1989). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2007: 1 other ancestor2003: 2 other ancestors1999: 3 other ancestors2006: 2 other ancestors2001: 4 other ancestors2000: 6 other ancestors2005: 2 other ancestors2004: 3 other ancestors1998: 2 other ancestors1990: 1 other ancestor2002: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1996: 1 other ancestor2022: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K082516 · Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws · Smith & Nephew, Inc. · 2008K162078 · EVOS Small Fragment Plating System · Smith & Nephew, Inc. · 2016 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 8 other ancestors3 generations back: 11 other ancestors4 generations back: 7 other ancestors7 generations back: 1 other ancestor8 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants K162078 · EVOS Small Fragment Plating System · Smith & Nephew, Inc. · 2016 · recalledK082516 · Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws · Smith & Nephew, Inc. · 2008K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations between
  3. 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  4. 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  5. 1 generation backK162078 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2016 · Recalled
  6. This deviceK201918 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2020
  7. Descendant · cites it directly · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
  8. Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
  9. Descendant · 2 generations on · 0 of its ownK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
  10. Descendant · 2 generations on · 0 of its ownK233396 Cannulated Screw SystemSmith & Nephew, Inc. · 2023
Show all 10 generations
  1. Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 3 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 2 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 1 generation backK162078 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2016 · Recalled
  11. This deviceK201918 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2020

Most influential descendants

Showing 4 of 4 · See all
  • K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · cites it directly3descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−10K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−9K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−8K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−7K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−4K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−3K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−2K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−1K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20161
0 (this device)K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.2020—
+1K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.2021—
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.20221
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.2025—
+2K233396Cannulated Screw SystemSmith & Nephew, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199110
199510
199610
199820
199930
200060
200140
200210
200320
200430
200520
200620
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202310
202510
FIG. 1 — Lineage of K201918, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)
Summary page 4
…phew Locking Bone Smith & Nephew, December 10, Plate System (PERI-LOC) Primary K033669 Inc. 2003 Predicate…
Smith & Nephew, Inc.20031
*K162078EVOS Small Fragment Plating System
Summary page 4
…2003 Predicate EVOS Small Fragment Plating Smith & Nephew, Inc. K162078 November 18, 2016 System Straight Plates and Screws PERI-LOC Periartic…
Smith & Nephew, Inc.20161
*K061352Peri-Loc Periarticular Locked Plating System for the Upper Extremity
Summary page 4
…System Straight Plates and Screws PERI-LOC Periarticular Locked Smith & Nephew, Inc. Plating System for the Upper K061352 June 8, 2006 Extremity PERI-LOC Proximal Femur Locking Smith & Nephew…
Smith & Nephew, Inc.2006—
*K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access
Summary page 4
…June 8, 2006 Extremity PERI-LOC Proximal Femur Locking Smith & Nephew, Inc. Bone Plates, Bone Screws and K072818 November 19, 2007 Cable Accessories PERI-LOC Periarticular Locked Smi…
Smith & Nephew, Inc.2007—
*K092015Peri-Loc Periarticular Locked Plating System
Summary page 4
…mber 19, 2007 Cable Accessories PERI-LOC Periarticular Locked Smith & Nephew, Inc. Plating System for Lower & Upper K092015 July 30, 2009 Extremity Smith & Nephew Bone Plate Smith & Nephew, Inc…
Smith & Nephew, Inc.20091
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 4
…July 30, 2009 Extremity Smith & Nephew Bone Plate Smith & Nephew, Inc. K993106 December 09, 1999 System (TC-100)…
Smith & Nephew, Inc.1999—

Also cleared against K033669: 27 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.20222

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 1, 2021Class IIZ-0366-2022Under Investigation by firmTesting vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Nov 1, 2021Class IIZ-0363-2022Under Investigation by firmTesting vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Nov 1, 2021Class IIZ-0365-2022Under Investigation by firmTesting vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Nov 1, 2021Class IIZ-0364-2022Under Investigation by firmTesting vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 12 of the 42 ancestors have a recall of any class.
  • Of its descendants, K203405 (Smith & Nephew, Inc., 2021) has gone furthest, with 3 descendants of its own.
  • 27 other devices also cite its predicate K033669.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

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 as stated in the FDA summary.

Also cleared against K033669

27 other devices cite the same predicate.

  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip…Smith & Nephew, Inc. · 20221 recall
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 20211 recall
  • K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
  • K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018
  • K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc. · 2017
  • K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 20161 recall

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K201918 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201918: 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/K201918

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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