510(k) Report

510(k) · Cleared

Recalled · 2026

Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws

K213126510(k) TraditionalCleared Sep 29, 2022367-day reviewClass II21 CFR 888.3030Recalls 1

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

Smith & Nephew, Inc. · JDO Device, Fixation, Proximal Femoral, Implant

Cleared on Sep 29, 2022 as substantially equivalent to K933027 (Smith & Nephew Richards, Inc., 1994) and 41 other predicates after a 367-day review. Its family tree reaches back 14 generations to 1996. 2 later devices descend from it. It has been recalled once.

Decided
Sep 29, 2022
Review
367 days
Class
Class II
Product code
JDO
Recalls
1
Predicates
42

Its longest line of descent runs back 14 generations to K962616 (1996). 234 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2021: 1 other ancestor2020: 3 other ancestors2019: 1 other ancestor2018: 1 other ancestor2017: 3 other ancestors2016: 3 other ancestors2015: 1 other ancestor2014: 5 other ancestors2012: 1 other ancestor2011: 4 other ancestors2010: 6 other ancestors2009: 7 other ancestors2008: 7 other ancestors2007: 7 other ancestors2006: 12 other ancestors2003: 7 other ancestors1999: 8 other ancestors1995: 12 other ancestors1994: 7 other ancestors2005: 12 other ancestors2004: 11 other ancestors2002: 18 other ancestors2001: 18 other ancestors2000: 14 other ancestors1997: 9 other ancestors1996: 14 other ancestors1990: 3 other ancestors1982: 1 other ancestor1998: 12 other ancestors1993: 3 other ancestors1991: 1 other ancestor1989: 2 other ancestors1988: 1 other ancestor1984: 1 other ancestor1979: 1 other ancestor1992: 2 other ancestors1985: 1 other ancestor2023: 1 descendant cleared2025: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 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 · recalledK181533 · EVOS Wrist Fracture Plating System · Smith & Nephew, Inc. · 2018K210837 · Smith & Nephew Plates and Screws · Smith & Nephew, Inc. · 2021 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 34 other ancestors2 generations back: 50 other ancestors3 generations back: 52 other ancestors4 generations back: 38 other ancestors5 generations back: 22 other ancestors6 generations back: 12 other ancestors7 generations back: 9 other ancestors8 generations back: 2 other ancestors9 generations back: 1 other ancestor 1 generation forward: 2 descendants K210837 · Smith & Nephew Plates and Screws · Smith & Nephew, Inc. · 2021 · recalledK181533 · EVOS Wrist Fracture Plating System · Smith & Nephew, Inc. · 2018K140814 · 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 · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations between
  3. 3 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  4. 2 generations backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  5. 1 generation backK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
  6. This deviceK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022
  7. Descendant · cites it directly · 0 of its ownK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
  8. Descendant · cites it directly · 0 of its ownK233396 Cannulated Screw SystemSmith & Nephew, Inc. · 2023
Show all 14 generations
  1. Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 7 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 6 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 5 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  11. 4 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  12. 3 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  13. 2 generations backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  14. 1 generation backK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
  15. This deviceK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K252019CurvaFix Low Profile SystemCurvafix, Inc. · 2025 · cites it directly0descendants
  • K233396Cannulated Screw SystemSmith & Nephew, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−13K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−12K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−11K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−10K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−9K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−8K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−7K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−6K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−5K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
−4K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
−3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
−2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.2018—
−1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20211
0 (this device)K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.2022—
+1K252019CurvaFix Low Profile SystemCurvafix, Inc.2025—
+1K233396Cannulated Screw SystemSmith & Nephew, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198410
198510
198810
198920
199030
199110
199220
199330
199470
1995120
1996140
199790
1998120
199980
2000140
2001180
2002180
200370
2004110
2005120
2006120
200770
200870
200970
201060
201140
201210
201450
201510
201630
201730
201810
201910
202030
202110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202510
FIG. 1 — Lineage of K213126, 1996–2025Source: 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 JDO? 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 JDO device

  1. #1 K193029 Conquest FNscore 10.9 · 11 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? (42)

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
*K933027The Modular Nail
Summary page 15
…tion Clearance Date Number K933027 02/22/1994 Smith & Nephew K952697 09/12/1995 Smith & Nephew,…
Smith & Nephew Richards, Inc.1994—
*K952697Titanium Classic Compression Hip Screw System
Summary page 15
…Number K933027 02/22/1994 Smith & Nephew K952697 09/12/1995 Smith & Nephew, Compression Hip Screw K954712 10/31/1995 Inc.…
Smith & Nephew Richards, Inc.1995—
*K954712Intramedullary Hip Screw (Modification)
Summary page 15
…02/22/1994 Smith & Nephew K952697 09/12/1995 Smith & Nephew, Compression Hip Screw K954712 10/31/1995 Inc. (CHS) K993289 12/20/1999…
Smith & Nephew Richards, Inc.1995—
*K993289Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System
Summary page 15
…09/12/1995 Smith & Nephew, Compression Hip Screw K954712 10/31/1995 Inc. (CHS) K993289 12/20/1999 K210837 06/29/2021 Table 5.2: Substantially Equiv…
Smith & Nephew, Inc.1999—
*K210837Smith & Nephew Plates and Screws
Summary page 15
…K954712 10/31/1995 Inc. (CHS) K993289 12/20/1999 K210837 06/29/2021 Table 5.2: Substantially Equivalent Predicates to the CONQUEST FN System…
Smith & Nephew, Inc.20211
*K152686Conquest FN
Summary page 15
…iption Clearance Date Number K152686 03/17/2016 Smith & Nephew, Smith & Nephew K172785 12/22/2017 Inc. CONQUEST…
Smith & Nephew2016—
*K172785Conquest FN
Summary page 15
…Number K152686 03/17/2016 Smith & Nephew, Smith & Nephew K172785 12/22/2017 Inc. CONQUEST FN System K193029 02/28/2020…
Smith & Nephew2017—
*K193029Conquest FN
Summary page 15
…K152686 03/17/2016 Smith & Nephew, Smith & Nephew K172785 12/22/2017 Inc. CONQUEST FN System K193029 02/28/2020 K210837 06/29/2021 Table 5.3: Substantially Equiv…
Smith & Nephew, Inc.2020—
*K132296D-Rad Smart Pack
Summary page 15
…on Clearance Date Number K132296 01/07/2014 Smith & Nephew, D-Rad Plating System K161665 11/15/2016 Inc.…
Smith & Nephew, Inc.20144
*K161665VLP Wrist Fracture System
Summary page 15
…Number K132296 01/07/2014 Smith & Nephew, D-Rad Plating System K161665 11/15/2016 Inc. K210837 06/29/2021 Table 5.4: Substantially…
Smith & Nephew, Inc.2016—
*K140814Evos Mini-Fragment Plating System
Summary page 15
…ion Clearance Date Number K140814 05/07/2014 K162078 11/18/2016…
Smith & Nephew, Inc.20142
*K162078EVOS Small Fragment Plating System
Summary page 15
…Number K140814 05/07/2014 K162078 11/18/2016 K170457 06/14/2017…
Smith & Nephew, Inc.20161
*K170457EVOS Small Fragment Lower Extremity Plates
Summary page 15
…K140814 05/07/2014 K162078 11/18/2016 K170457 06/14/2017 K170887 04/24/2017…
Smith & Nephew, Inc.20171
*K170887EVOS Small Fragment Plating System
Summary page 15
…K162078 11/18/2016 K170457 06/14/2017 K170887 04/24/2017 K173293 01/08/2018 Smith & Nephew, Inc.…
Smith & Nephew, Inc.2017—
*K173293EVOS Small Fragment Upper Extremity Plates
Summary page 15
…K170457 06/14/2017 K170887 04/24/2017 K173293 01/08/2018 Smith & Nephew, Inc. EVOS Plating System K181533 08/09/2018…
Smith & Nephew, Inc.2018—
*K181533EVOS Wrist Fracture Plating System
Summary page 15
…04/24/2017 K173293 01/08/2018 Smith & Nephew, Inc. EVOS Plating System K181533 08/09/2018 K190253 03/11/2019…
Smith & Nephew, Inc.2018—
*K190253EVOS Small Fragment Upper Extremity Plates Line Additions
Summary page 15
…01/08/2018 Smith & Nephew, Inc. EVOS Plating System K181533 08/09/2018 K190253 03/11/2019 K201527 07/22/2020…
Smith & Nephew, Inc.2019—
*K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
Summary page 15
…K181533 08/09/2018 K190253 03/11/2019 K201527 07/22/2020 K201918 11/16/2020…
Smith & Nephew, Inc.2020—
*K201918EVOS Large Fragment Plating System
Summary page 15
…K190253 03/11/2019 K201527 07/22/2020 K201918 11/16/2020 K203405 01/27/2021…
Smith & Nephew, Inc.20204
*K203405EVOS Large Fragment Plating System
Summary page 15
…K201527 07/22/2020 K201918 11/16/2020 K203405 01/27/2021 K210837 06/29/2021 Table 5.5: Substantially Equivale…
Smith & Nephew, Inc.2021—
*K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)
Summary page 15
…ion Clearance Date Number K033669 12/10/2003 K051735 07/19/2005 Peri-Loc Per…
Smith & Nephew, Inc.20031
*K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Summary page 15
…Number K033669 12/10/2003 K051735 07/19/2005 Peri-Loc Periarticular and Smith & Nephew, K061352…
Smith & Nephew, Inc.2005—
*K061352Peri-Loc Periarticular Locked Plating System for the Upper Extremity
Summary page 15
…K051735 07/19/2005 Peri-Loc Periarticular and Smith & Nephew, K061352 06/08/2006 Variable-Angled Locked Plating Inc. K0622…
Smith & Nephew, Inc.2006—
*K062216Peri-Loc Periarticular Locked Plating System
Summary page 15
…K061352 06/08/2006 Variable-Angled Locked Plating Inc. K062216 09/15/2006 (VLP) Systems K071563 08/08/200…
Smith & Nephew, Inc.20061
*K071563Peri-Loc Periarticular Locked Plating System
Summary page 15
…Inc. K062216 09/15/2006 (VLP) Systems K071563 08/08/2007 K072818 11/19/2007…
Smith & Nephew, Inc.2007—
*K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe Access
Summary page 15
…(VLP) Systems K071563 08/08/2007 K072818 11/19/2007 K213126/S001 Page 5 of 6 ===…
Smith & Nephew, Inc.2007—
*K080434Intertan CHS Locking Plate System Prox Fem Plates/Screw
Summary page 16
…K213126/S001 Page 5 of 6 K080434 04/10/2008 K082516 09/17/2008…
Smith & Nephew, Inc.2008—
*K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws
Summary page 16
…13126/S001 Page 5 of 6 K080434 04/10/2008 K082516 09/17/2008 K083032 01/07/2009…
Smith & Nephew, Inc.2008—
*K083032Peri-Loc Bone Plating and Screw System
Summary page 16
…K080434 04/10/2008 K082516 09/17/2008 K083032 01/07/2009 K090675 06/04/2009…
Smith & Nephew, Inc.20092
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 16
…K082516 09/17/2008 K083032 01/07/2009 K090675 06/04/2009 K092015 07/30/2009…
Smith & Nephew, Inc.2009—
*K092015Peri-Loc Periarticular Locked Plating System
Summary page 16
…K083032 01/07/2009 K090675 06/04/2009 K092015 07/30/2009 K100325 05/04/2010…
Smith & Nephew, Inc.20091
*K100325Peri-Loc Locking Hole Inserts and Cable Accessories
Summary page 16
…K090675 06/04/2009 K092015 07/30/2009 K100325 05/04/2010 K110670 07/12/2011…
Smith & Nephew, Inc.2010—
*K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…
Summary page 16
…K092015 07/30/2009 K100325 05/04/2010 K110670 07/12/2011 K120667 04/04/2012…
Smith & Nephew, Inc.2011—
*K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…
Summary page 16
…K100325 05/04/2010 K110670 07/12/2011 K120667 04/04/2012 K132886 02/04/2014…
Smith & Nephew, Inc.2012—
*K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System
Summary page 16
…K110670 07/12/2011 K120667 04/04/2012 K132886 02/04/2014 K143050 12/18/2014…
Smith & Nephew, Inc.20142
*K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
Summary page 16
…K120667 04/04/2012 K132886 02/04/2014 K143050 12/18/2014 K152976 11/12/2015…
Smith & Nephew, Inc.2014—
*K152976VLP Mini-Mod Talus Plates
Summary page 16
…K132886 02/04/2014 K143050 12/18/2014 K152976 11/12/2015 K210837 06/29/2021 Table 5.6: Substantially Equival…
Smith & Nephew, Inc.2015—
*K123055Smith & Nephew, Inc Screw and Plate System Instrumentation
Summary page 16
…ion Clearance Date Number K123055 01/25/2013 Smith & Nephew, TC-100 Screw and Plating K993106…
Smith & Nephew, Inc.2013—
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 16
…K123055 01/25/2013 Smith & Nephew, TC-100 Screw and Plating K993106 12/09/1999 Inc. System K210837 06/29/2021 Tabl…
Smith & Nephew, Inc.1999—
*K060736Smith & Nephew 6.5MM and 8.0MM Cannulated Screws
Summary page 16
…ion Clearance Date Number K060736 04/18/2006 Smith & Nephew, K111994 10/11/2011 Inc. Cannul…
Smith & Nephew, Inc.20061
*K111994Smith & Nephew Cannulated Screws and Washers
Summary page 16
…Number K060736 04/18/2006 Smith & Nephew, K111994 10/11/2011 Inc. Cannulated Screws K133662 5/15/2014…
Smith & Nephew, Inc.2011—
*K133662Smith & Nephew Cannulated Captured Screw
Summary page 16
…K060736 04/18/2006 Smith & Nephew, K111994 10/11/2011 Inc. Cannulated Screws K133662 5/15/2014 K210837 06/29/2021 Conclusion In summary, the only di…
Smith & Nephew, Inc.2014—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K252019CurvaFix Low Profile SystemCurvafix, Inc.20250
K233396Cannulated Screw SystemSmith & Nephew, Inc.20230

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 6, 2026Not classifiedZ-0318-2027Labeling Change ControlIncorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 45 of the 234 ancestors have a recall of any class.
  • Of its descendants, K252019 (Curvafix, Inc., 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JDO devices

JDO Device, Fixation, Proximal Femoral, Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · JDO

1in 2023

2008: 22014: 12016: 12017: 12018: 12020: 12021: 12022: 12023: 12026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDO

Too few JDO 510(k)s in any year since 2007 to give a median.

Recalls per year · JDO

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JDO

1in 2025

2007: 42008: 12009: 12010: 62011: 62012: 92013: 522014: 152015: 192016: 442017: 262018: 182019: 102020: 192021: 102022: 32023: 52024: 22025: 1
2007high 52 (2013) · low 1 (2008)2025

MAUDE reports naming product code JDO, 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
20070—04
20082—01
20090—01
20100—06
20110—06
20120—09
20130—152
20141—015
20150—019
20161—044
20171—026
20181—018
20190—010
20201—019
20211—010
20221—03
20231—05
20240—02
20250—01
20261—0—

What is it indicated for?

The EVOS MINI 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 EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The…

Read the full statement (1,018 words)

The EVOS MINI 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 EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) 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.

The EVOS Partial Articular and Anti-Glide Plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.

The EVOS Wrist Fracture Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.

The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

The PERI-LOC Plate and Screw System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and bone screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot.

The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.

The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12—18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone.

The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.

The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.

The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.

The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius.

Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)

2. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.

3. Osteotomies for patients with diseases or deformities of the hip.

4. Hip arthrodesis.

5. Supracondylar fractures and distal femoral fractures using a supracondylar plate.

6. Ipsilateral femoral shaft/neck fractures.

CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.

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

Cite this page

510(k) Report. “K213126: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213126

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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