510(k) Report

510(k) · Cleared

Recalled · 2026

Smith & Nephew Plates and Screws

K210837510(k) TraditionalCleared Jun 29, 202199-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. · HRS Plate, Fixation, Bone

Cleared on Jun 29, 2021 as substantially equivalent to K201527 (Smith & Nephew, Inc., 2020) and 37 other predicates after a 99-day review. Its family tree reaches back 13 generations to 1996. 7 later devices descend from it. It has been recalled once.

Decided
Jun 29, 2021
Review
99 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
38

Its longest line of descent runs back 13 generations to K962616 (1996). 211 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2020: 2 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: 6 other ancestors1999: 8 other ancestors1995: 10 other ancestors2005: 12 other ancestors2004: 11 other ancestors2002: 18 other ancestors2001: 18 other ancestors2000: 14 other ancestors1997: 5 other ancestors1996: 13 other ancestors1990: 2 other ancestors1982: 1 other ancestor1998: 10 other ancestors1991: 1 other ancestor1989: 2 other ancestors1979: 1 other ancestor1994: 3 other ancestors1993: 2 other ancestors1992: 1 other ancestor2025: 2 descendants cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 2 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. · 2013K140814 · Evos Mini-Fragment Plating System · Smith & Nephew, Inc. · 2014 · recalledK181533 · EVOS Wrist Fracture Plating System · Smith & Nephew, Inc. · 201819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 31 other ancestors2 generations back: 49 other ancestors3 generations back: 46 other ancestors4 generations back: 28 other ancestors5 generations back: 20 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: 4 descendants2 generations forward: 3 descendants K181533 · 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 · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 9 generations between
  3. 3 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  4. 2 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  5. 1 generation backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  6. This deviceK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021
  7. Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
  8. Descendant · cites it directly · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
  9. Descendant · 2 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
  10. Descendant · cites it directly · 0 of its ownK253713 Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026
  11. Descendant · 2 generations on · 0 of its ownK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
Show all 13 generations
  1. Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 6 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 5 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 4 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  11. 3 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  12. 2 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  13. 1 generation backK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  14. This deviceK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2022: 12023: 22025: 22026: 2
2022high 2 (2023) · low 0 (2024)2026

Most influential descendants

Showing 5 of 7 · See all
  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · cites it directly2descendants
  • K233017TM Plating SystemTyber Medical, LLC · 2023 · cites it directly1descendant
  • K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · 2 generations on0descendants
  • K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026 · cites it directly0descendants
  • K252019CurvaFix Low Profile SystemCurvafix, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−12K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−11K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−10K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−9K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−7K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−6K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−5K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−4K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
−3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
−2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
−1K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.2018—
0 (this device)K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.2021—
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.20221
+1K233017TM Plating SystemTyber Medical, LLC2023—
+2K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026—
+1K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.2026—
+2K252019CurvaFix Low Profile SystemCurvafix, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198920
199020
199110
199210
199320
199430
1995100
1996130
199750
1998100
199980
2000140
2001180
2002180
200360
2004110
2005120
2006120
200770
200870
200970
201060
201140
201210
201450
201510
201630
201730
201810
201910
202020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202320
202520
202620
FIG. 1 — Lineage of K210837, 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? (38)

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
*K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
Summary page 11
…JDO, KTT, HRS, HWC, HTN, NDG, HTY Predicate Device: Smith & Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP…
Smith & Nephew, Inc.2020—
*K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…
Summary page 11
…TT, HRS, HWC, HTN, NDG, HTY Predicate Device: Smith & Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K15…
Smith & Nephew, Inc.2012—
*K161665VLP Wrist Fracture System
Summary page 11
…Smith & Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw…
Smith & Nephew, Inc.2016—
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 11
…Nephew Plates and Screws Systems: EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (…
Smith & Nephew, Inc.1999—
*K152976VLP Mini-Mod Talus Plates
Summary page 11
…EVOS (K201527), Peri-Loc (K120667 ), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029),…
Smith & Nephew, Inc.2015—
*K993289Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System
Summary page 11
…), D-Rad (K161665), TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029), and cannulated screws (K133662) Device Description The purpose o…
Smith & Nephew, Inc.1999—
*K193029Conquest FN
Summary page 11
…, TC-100 (K993106), VLP Mini-Mod (K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029), and cannulated screws (K133662) Device Description The purpose of this Traditional 510(…
Smith & Nephew, Inc.2020—
*K133662Smith & Nephew Cannulated Captured Screw
Summary page 11
…(K152976), Compression Hip Screw (CHS) (K993289), CONQUEST FN (K193029), and cannulated screws (K133662) Device Description The purpose of this Traditional 510(k) is to add the MR safety information to the labeling, and update the…
Smith & Nephew, Inc.2014—
*K952697Titanium Classic Compression Hip Screw System
Summary page 15
…tion Clearance Date Number 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
…Number Smith & Nephew K952697 09/12/1995 Smith & Nephew, Compression Hip Screw K954712 10/31/1995 Inc. (CHS) K993289 12/20/1999 Table 5.2: Substantially…
Smith & Nephew Richards, Inc.1995—
*K152686Conquest FN
Summary page 15
…iption Clearance Date Number K152686 03/17/2016 Smith & Nephew, Smith & Nephew K172785 12/22…
Smith & Nephew2016—
*K172785Conquest FN
Summary page 15
…K152686 03/17/2016 Smith & Nephew, Smith & Nephew K172785 12/22/2017 Inc. CONQUEST FN System K193029 0…
Smith & Nephew2017—
*K132296D-Rad Smart Pack
Summary page 15
…on Clearance Date Number Smith & Nephew, K132296 01/07/2014 D-Rad Plating System Inc. K161665…
Smith & Nephew, Inc.20144
*K140814Evos Mini-Fragment Plating System
Summary page 15
…ion Clearance Date Number K140814 05/07/2014 K162078 11/18/2016 Smith & Nephew,…
Smith & Nephew, Inc.20142
*K162078EVOS Small Fragment Plating System
Summary page 15
…Number K140814 05/07/2014 K162078 11/18/2016 Smith & Nephew, K170457 06/14/2017 Inc. EVOS P…
Smith & Nephew, Inc.20161
*K170457EVOS Small Fragment Lower Extremity Plates
Summary page 15
…K140814 05/07/2014 K162078 11/18/2016 Smith & Nephew, K170457 06/14/2017 Inc. EVOS Plating System K170887 04/24/2017…
Smith & Nephew, Inc.20171
*K170887EVOS Small Fragment Plating System
Summary page 15
…K162078 11/18/2016 Smith & Nephew, K170457 06/14/2017 Inc. EVOS Plating System K170887 04/24/2017 K173293 01/08/2018…
Smith & Nephew, Inc.2017—
*K173293EVOS Small Fragment Upper Extremity Plates
Summary page 15
…K170457 06/14/2017 Inc. EVOS Plating System K170887 04/24/2017 K173293 01/08/2018 K181533 08/09/2018…
Smith & Nephew, Inc.2018—
*K181533EVOS Wrist Fracture Plating System
Summary page 15
…K170887 04/24/2017 K173293 01/08/2018 K181533 08/09/2018 K210837 Page 5 of 6 ==…
Smith & Nephew, Inc.2018—
*K190253EVOS Small Fragment Upper Extremity Plates Line Additions
Summary page 16
…K210837 Page 5 of 6 K190253 03/11/2019 K201527 07/22/2020 Table 5.5: Substantially Equiv…
Smith & Nephew, Inc.2019—
*K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)
Summary page 16
…ion Clearance Date Number K033669 12/10/2003 K051735 07/19/2005…
Smith & Nephew, Inc.20031
*K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Summary page 16
…Number K033669 12/10/2003 K051735 07/19/2005 K061352 06/08/2006…
Smith & Nephew, Inc.2005—
*K061352Peri-Loc Periarticular Locked Plating System for the Upper Extremity
Summary page 16
…K033669 12/10/2003 K051735 07/19/2005 K061352 06/08/2006 K062216 09/15/2006…
Smith & Nephew, Inc.2006—
*K062216Peri-Loc Periarticular Locked Plating System
Summary page 16
…K051735 07/19/2005 K061352 06/08/2006 K062216 09/15/2006 K071563 08/08/2007…
Smith & Nephew, Inc.20061
*K071563Peri-Loc Periarticular Locked Plating System
Summary page 16
…K061352 06/08/2006 K062216 09/15/2006 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 16
…K062216 09/15/2006 K071563 08/08/2007 K072818 11/19/2007 K080434 04/10/2008 Peri-Loc Per…
Smith & Nephew, Inc.2007—
*K080434Intertan CHS Locking Plate System Prox Fem Plates/Screw
Summary page 16
…K071563 08/08/2007 K072818 11/19/2007 K080434 04/10/2008 Peri-Loc Periarticular and K082516 09/17/2008 Smith & Nephew,…
Smith & Nephew, Inc.2008—
*K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws
Summary page 16
…K072818 11/19/2007 K080434 04/10/2008 Peri-Loc Periarticular and K082516 09/17/2008 Smith & Nephew, Variable-Angled Locked Plating K083032 01/07/2009 Inc.…
Smith & Nephew, Inc.2008—
*K083032Peri-Loc Bone Plating and Screw System
Summary page 16
…0434 04/10/2008 Peri-Loc Periarticular and K082516 09/17/2008 Smith & Nephew, Variable-Angled Locked Plating K083032 01/07/2009 Inc. (VLP) Systems K090675 06/04/2009…
Smith & Nephew, Inc.20092
*K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
Summary page 16
…09/17/2008 Smith & Nephew, Variable-Angled Locked Plating K083032 01/07/2009 Inc. (VLP) Systems K090675 06/04/2009 K092015 07/30/2009…
Smith & Nephew, Inc.2009—
*K092015Peri-Loc Periarticular Locked Plating System
Summary page 16
…ing K083032 01/07/2009 Inc. (VLP) Systems 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—
*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 Table 5.6: Substantially Equivale…
Smith & Nephew, Inc.2014—
*K123055Smith & Nephew, Inc Screw and Plate System Instrumentation
Summary page 16
…ion Clearance Date Number Smith & Nephew, TC-100 Screw and Plating K123055 01/25/2013 Inc. System K993106 12/09/1999 Table 5.7: Substantially Equivale…
Smith & Nephew, Inc.2013—
*K060736Smith & Nephew 6.5MM and 8.0MM Cannulated Screws
Summary page 16
…on Clearance Date Number K060736 04/18/2006 Smith & Nephew, Inc. Cannulated Screws K111994 10/11/2011…
Smith & Nephew, Inc.20061
*K111994Smith & Nephew Cannulated Screws and Washers
Summary page 16
…Number K060736 04/18/2006 Smith & Nephew, Inc. Cannulated Screws K111994 10/11/2011 K133662 5/15/2014 Conclusion In summary, the only…
Smith & Nephew, Inc.2011—

Also cleared against K201527: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.20222
K233017TM Plating SystemTyber Medical, LLC20231
K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260
K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250

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 25 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 41 of the 211 ancestors have a recall of any class.
  • Of its descendants, K213126 (Smith & Nephew, Inc., 2022) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K201527.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?

Adult Indications 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…

Read the full statement (1,106 words)

Adult Indications

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.]

Pediatric Indications

1. Congenital coxa vara.

2. Congenital dislocation of the hip.

3. Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.

4. Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.

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

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

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 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.

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.

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.

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. “K210837: Smith & Nephew Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210837

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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