510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Evos Mini-Fragment Plating System

K140814510(k) SpecialCleared May 7, 201436-day reviewClass II21 CFR 888.3030Recalls 2

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 May 7, 2014 as substantially equivalent to K132886 (Smith & Nephew, Inc., 2014) and 2 other predicates after a 36-day review. Its family tree reaches back 11 generations to 1996. 32 later devices descend from it. It has been recalled 2 times.

Decided
May 7, 2014
Review
36 days
Class
Class II
Product code
HRS
Recalls
2
Predicates
3

Its longest line of descent runs back 11 generations to K962616 (1996). 105 ancestors in all, the oldest K792022 (1979). 32 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2009: 4 other ancestors2010: 2 other ancestors2008: 2 other ancestors2007: 3 other ancestors2006: 5 other ancestors2005: 5 other ancestors2003: 3 other ancestors2001: 10 other ancestors1999: 4 other ancestors1997: 5 other ancestors1996: 7 other ancestors1995: 7 other ancestors2004: 7 other ancestors2000: 10 other ancestors1990: 2 other ancestors1982: 1 other ancestor2002: 3 other ancestors1998: 6 other ancestors1994: 1 other ancestor1993: 2 other ancestors1991: 1 other ancestor1989: 2 other ancestors1979: 1 other ancestor2024: 7 descendants cleared2025: 7 descendants cleared2018: 3 descendants cleared2022: 4 descendants cleared2021: 2 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2023: 3 descendants cleared2026: 3 descendants clearedK962616 · 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. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 23 other ancestors3 generations back: 34 other ancestors4 generations back: 26 other ancestors5 generations back: 9 other ancestors 1 generation forward: 11 descendants2 generations forward: 14 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant5 generations forward: 2 descendants K123055 · 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+5
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations between
  3. 3 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  4. 2 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  5. 1 generation backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  6. This deviceK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014
  7. Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  8. Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
  9. Descendant · cites it directly · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
  10. Descendant · cites it directly · 9 of its ownK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  11. Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
Show all 11 generations
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 4 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 3 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 2 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  11. 1 generation backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  12. This deviceK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2017: 22018: 32020: 12021: 22022: 42023: 32024: 72025: 72026: 3
2017high 7 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 32 · See all
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
  • K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · cites it directly10descendants
  • K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018 · cites it directly9descendants
  • K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−10K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−9K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−8K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−4K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−3K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−2K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
−1K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
0 (this device)K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—
+1K180554ANTHEM Fracture SystemGlobus Medical, Inc.2018—
+1K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.2018—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198920
199020
199110
199320
199410
199570
199670
199750
199860
199940
2000100
2001100
200230
200330
200470
200550
200650
200730
200820
200940
201020
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201830
202010
202120
202240
202330
202470
202570
202630
FIG. 1 — Lineage of K140814, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System
Summary page 1
…ect EVOS Mini-Fragment Plating System is a modification to a subset of the devices previously cleared Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (K132886). It is an internal fixation plating system comprised of assorted implantable, small utility "fat"locking bone plates and compati…
Smith & Nephew, Inc.20142
*K123055Smith & Nephew, Inc Screw and Plate System Instrumentation
Summary page 2
…ii 132886 02-04-2014 _________________Fragment Plating System Smith &Nephew, Inc. Plate and Screw Instruments K(123055 01-25-2013 Smith &Nephew, Inc. VPFOPltnSrw K090675 06-04-2009…
Smith & Nephew, Inc.2013—
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 2
…ing System Smith &Nephew, Inc. Plate and Screw Instruments K(123055 01-25-2013 Smith &Nephew, Inc. VPFOPltnSrw K090675 06-04-2009 System and Accessonies Summary of Pre-Clinical Testing To further support a…
Smith & Nephew, Inc.2009—

Also cleared against K132886: 8 other devices →

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714
K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810
K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189
K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20217
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.20222
K220937Arthrex Mini Fragment SystemArthrex, Inc.20222
K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250
K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250
K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250
K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 24, 2020Class IIZ-2945-2020Error in labelingMultiple or incorrect expiration dates were provided on the affected designation labels.
Nov 29, 2017Class IIZ-0408-2018Employee errorOne lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
  • 25 of the 105 ancestors have a recall of any class.
  • Of its descendants, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 descendants of its own.
  • 8 other devices also cite its predicate K132886.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K132886

8 other devices cite the same predicate.

  • K221150Advanced Bone PlateDouble Medical Technology, Inc. · 2023
  • 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
  • K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
  • K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  • K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. · 2016

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/K140814 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140814: Evos Mini-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/K140814

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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