510(k) Report

510(k) · Cleared

Cleared

EVOS Pelvic and Acetabular System

K241666510(k) TraditionalCleared Feb 19, 2025254-day reviewClass II21 CFR 888.3030

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

Smith & Nephew · HRS Plate, Fixation, Bone

Cleared on Feb 19, 2025 as substantially equivalent to K162078 (Smith & Nephew, Inc., 2016) and 9 other predicates after a 254-day review. Its family tree reaches back 12 generations to 1996.

Decided
Feb 19, 2025
Review
254 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
10

Its longest line of descent runs back 12 generations to K962616 (1996). 229 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 2 other ancestors2018: 1 other ancestor2017: 2 other ancestors2016: 1 other ancestor2012: 2 other ancestors2006: 14 other ancestors1999: 10 other ancestors2014: 1 other ancestor2013: 2 other ancestors2010: 7 other ancestors2009: 9 other ancestors2007: 10 other ancestors2005: 16 other ancestors2004: 10 other ancestors2003: 8 other ancestors2001: 17 other ancestors2000: 16 other ancestors1990: 3 other ancestors2008: 6 other ancestors2002: 12 other ancestors1997: 8 other ancestors1996: 17 other ancestors1995: 12 other ancestors2011: 1 other ancestor1998: 7 other ancestors1992: 5 other ancestors1991: 1 other ancestor1989: 4 other ancestors1982: 1 other ancestor1994: 6 other ancestors1993: 3 other ancestors1979: 1 other ancestor1980: 1 other ancestor1981: 1 other ancestorK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (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. · 2006×2: 2 generations cleared close together, K082516 (2008), K083032 (2009) K123055 · Smith & Nephew, Inc Screw and Plate System Instrumentation · Smith & Nephew, Inc. · 2013K140814 · Evos Mini-Fragment Plating System · Smith & Nephew, Inc. · 2014 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 9 other ancestors2 generations back: 22 other ancestors3 generations back: 43 other ancestors4 generations back: 57 other ancestors5 generations back: 38 other ancestors6 generations back: 27 other ancestors7 generations back: 12 other ancestors8 generations back: 6 other ancestors9 generations back: 3 other ancestors K140814 · Evos Mini-Fragment Plating System · Smith & Nephew, Inc. · 2014 · recalledK123055 · Smith & Nephew, Inc Screw and Plate System Instrumentation · Smith & Nephew, Inc. · 2013K083032 · Peri-Loc Bone Plating and Screw System · Smith & Nephew, Inc. · 2009 · 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 · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  4. 2 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  5. 1 generation backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  6. This deviceK241666 EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 4 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 3 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  11. 2 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  12. 1 generation backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  13. This deviceK241666 EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−4K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
−2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
−1K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
0 (this device)K241666EVOS Pelvic and Acetabular SystemSmith & Nephew2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198110
198210
198940
199030
199110
199250
199330
199460
1995120
1996170
199780
199870
1999100
2000160
2001170
2002120
200380
2004100
2005160
2006140
2007100
200860
200990
201070
201110
201220
201320
201410
201610
201720
201810
202220
FIG. 1 — Lineage of K241666, 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? (10)

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
*K162078EVOS Small Fragment Plating System
Summary page 5
…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code K162078 EVOS Small-Fragment Plating System | HRS K140814 EVOS Mi…
Smith & Nephew, Inc.20161
*K140814Evos Mini-Fragment Plating System
Summary page 5
…rimary Predicate is listed first) Product Code K162078 EVOS Small-Fragment Plating System | HRS K140814 EVOS Mini-Fragment Plating System | HRS K060736 Smith &…
Smith & Nephew, Inc.20142
*K060736Smith & Nephew 6.5MM and 8.0MM Cannulated Screws
Summary page 5
…ment Plating System | HRS K140814 EVOS Mini-Fragment Plating System | HRS K060736 Smith & Nephew 6.5mm and 8.0mm Cannulated Screws | HWC K170887 EVOS Sm…
Smith & Nephew, Inc.20061
*K170887EVOS Small Fragment Plating System
Summary page 5
…ent Plating System | HRS K060736 Smith & Nephew 6.5mm and 8.0mm Cannulated Screws | HWC K170887 EVOS Small Fragment Plating System | HRS K173293 EVOS Sm…
Smith & Nephew, Inc.2017—
*K173293EVOS Small Fragment Upper Extremity Plates
Summary page 5
…6.5mm and 8.0mm Cannulated Screws | HWC K170887 EVOS Small Fragment Plating System | HRS K173293 EVOS Small Fragment Upper Extremity Plates | HRS K122538 Acumed…
Smith & Nephew, Inc.2018—
*K122538Acumed Pelvic Bone Plate System
Summary page 5
…ment Plating System | HRS K173293 EVOS Small Fragment Upper Extremity Plates | HRS K122538 Acumed Pelvic Bone Plate System | HRS K063166 ITS Pel…
Acumed, LLC20121
*K063166I.T.S. Pelvic Reconstruction System
Summary page 5
…ment Upper Extremity Plates | HRS K122538 Acumed Pelvic Bone Plate System | HRS K063166 ITS Pelvic Reconstruction System | HRS K210935 ITS Pel…
I.T.S. Implantat-Technologie-Systeme GmbH20062
*K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
Summary page 5
…one Plate System | HRS K063166 ITS Pelvic Reconstruction System | HRS K210935 ITS Pelvic Reconstruction System (PRS RX & Phoenix) | HRS K221809 DePuy S…
I.T.S. GmbH20221
*K221809DePuy Synthes 3.5mm Intrapelvic Acetabular System
Summary page 5
…nstruction System | HRS K210935 ITS Pelvic Reconstruction System (PRS RX & Phoenix) | HRS K221809 DePuy Synthes 3.5mm Intrapelvic Acetabular System | HRS K993106 Smith &…
DePuy Synthes2022—
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 5
…nstruction System (PRS RX & Phoenix) | HRS K221809 DePuy Synthes 3.5mm Intrapelvic Acetabular System | HRS K993106 Smith & Nephew Bone Plate System | HRS IDevice Description Summary…
Smith & Nephew, Inc.1999—

Also cleared against K162078: 8 other devices →

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 29 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 46 of the 229 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K162078.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabulum in skeletally mature patients.

Indications for use as stated in the FDA summary.

Also cleared against K162078

8 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
  • K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 20204 recalls
  • K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  • K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. · 2018

More from Smith & Nephew

16 FDA decisions under this applicant name. See the company

  • K240487EVOS Patella PlatesSmith & Nephew · 2024
  • K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew · 2024
  • K232457Q-FIX ULTRA All-Suture AnchorSmith & Nephew · 2023
  • K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
  • K203566Tablet ApplicationSmith & Nephew · 2021

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/K241666 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241666: EVOS Pelvic and Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241666

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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