510(k) Report

510(k) · Cleared

Cleared

EVOS Small Fragment Plating System

K172262510(k) SpecialCleared Aug 23, 201727-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, Inc. · HRS Plate, Fixation, Bone

Cleared on Aug 23, 2017 as substantially equivalent to K162078 (Smith & Nephew, Inc., 2016) after a 27-day review. Its family tree reaches back 10 generations to 1996. 9 later devices descend from it.

Decided
Aug 23, 2017
Review
27 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K962616 (1996). 33 ancestors in all, the oldest K890939 (1989). 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2000: 5 other ancestors1999: 2 other ancestors2005: 1 other ancestor2001: 4 other ancestors2004: 3 other ancestors1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1996: 1 other ancestor2023: 4 descendants cleared2026: 3 descendants cleared2024: 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 2 generations back: 4 other ancestors3 generations back: 4 other ancestors4 generations back: 7 other ancestors5 generations back: 6 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 4 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 deviceK172262 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017
  7. Descendant · cites it directly · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
  8. Descendant · 2 generations on · 4 of its ownK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
  9. Descendant · 3 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
  10. Descendant · 3 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
  11. Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 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 deviceK172262 EVOS Small Fragment Plating SystemSmith & Nephew, Inc. · 2017

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2023: 42024: 12025: 12026: 3
2023high 4 (2023) · low 1 (2024)2026

Most influential descendants

Showing 5 of 9 · See all
  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · cites it directly8descendants
  • K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH · 2023 · 2 generations on4descendants
  • K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 3 generations on2descendants
  • K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 3 generations on1descendant
  • K233017TM Plating SystemTyber Medical, LLC · 2023 · 2 generations on1descendant
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)K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2017—
+1K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…Stryker GmbH2023—
+2K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia…Stryker GmbH2023—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH2025—
+3K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH2026—
+2K233017TM Plating SystemTyber Medical, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
199610
199820
199920
200050
200140
200310
200430
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202340
202410
202510
202630
FIG. 1 — Lineage of K172262, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (1)

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 4
…Number Smith & Nephew, Inc. EVOS November 18, Smith & Nephew, Inc. K162078 Small Fragment Plating System 2016 Device Description The subject of this spec…
Smith & Nephew, Inc.20161

Also cleared against K162078: 8 other devices →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238

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 21 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 9 of the 33 ancestors have a recall of any class.
  • Of its descendants, K222381 (Stryker GmbH, 2023) has gone furthest, with 8 descendants of its own.
  • 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. 2017, 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 Small Fragment Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K162078

8 other devices cite the same predicate.

  • K241666EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025
  • 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

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/K172262 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172262: EVOS Small 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/K172262

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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