510(k) Report

510(k) · Cleared

Cleared

VLP Wrist Fracture System

K161665510(k) TraditionalCleared Nov 15, 2016152-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 Nov 15, 2016 as substantially equivalent to K132296 (Smith & Nephew, Inc., 2014) and 5 other predicates after a 152-day review. Its family tree reaches back 11 generations to 1996. 10 later devices descend from it.

Decided
Nov 15, 2016
Review
152 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
6

Its longest line of descent runs back 11 generations to K962616 (1996). 46 ancestors in all, the oldest K890939 (1989). 10 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2005: 2 other ancestors1999: 3 other ancestors2011: 1 other ancestor2007: 1 other ancestor2006: 2 other ancestors2003: 2 other ancestors2001: 5 other ancestors2000: 7 other ancestors2004: 3 other ancestors1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestor2018: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2025: 2 descendants cleared2023: 2 descendants cleared2026: 2 descendants 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. · 2006×2: 2 generations cleared close together, K082516 (2008), K083032 (2009) K132296 · D-Rad Smart Pack · Smith & Nephew, Inc. · 2014 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 10 other ancestors4 generations back: 12 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K132296 · D-Rad Smart Pack · Smith & Nephew, Inc. · 2014 · recalledK083032 · 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 · 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 backK132296 D-Rad Smart PackSmith & Nephew, Inc. · 2014 · Recalled
  6. This deviceK161665 VLP Wrist Fracture SystemSmith & Nephew, Inc. · 2016
  7. Descendant · cites it directly · 9 of its ownK181533 EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018
  8. Descendant · cites it directly · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
  9. Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
  11. Descendant · 3 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
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 backK132296 D-Rad Smart PackSmith & Nephew, Inc. · 2014 · Recalled
  12. This deviceK161665 VLP Wrist Fracture SystemSmith & Nephew, Inc. · 2016

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2018: 12021: 12022: 22023: 22025: 22026: 2
2018high 2 (2022) · low 0 (2019)2026

Most influential descendants

Showing 5 of 10 · See all
  • K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc. · 2018 · cites it directly9descendants
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · cites it directly7descendants
  • 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 · 2 generations on1descendant
  • K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · 3 generations on0descendants
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
−1K132296D-Rad Smart PackSmith & Nephew, Inc.20144
0 (this device)K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.2016—
+1K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.2018—
+1K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.20211
+1K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.20221
+2K233017TM Plating SystemTyber Medical, LLC2023—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199110
199510
199610
199820
199930
200070
200150
200210
200320
200430
200520
200620
200710
201110
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202110
202220
202320
202520
202620
FIG. 1 — Lineage of K161665, 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? (6)

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
*K132296D-Rad Smart Pack
Summary page 4
…Number Smith & Nephew, Inc. D-RAD Smith & Nephew, Inc. K132296 January 7, 2014 SMARTPACK (primary predicate) Smith & Nephew B…
Smith & Nephew, Inc.20144
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 4
…predicate) Smith & Nephew Bone Plate December 9, Smith & Nephew, Inc. K993106 System 1999 Synthes (USA) Synthes 3.5mm…
Smith & Nephew, Inc.1999—
*K043185Synthes 3.5MM Cortex Screws
Summary page 4
…K993106 System 1999 Synthes (USA) Synthes 3.5mm Cortex Screws K043185 February 3, 2005 PERI-LOC Periarticular Locked…
Synthes (Usa)2005—
*K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws
Summary page 4
…r Locked September 17, Smith & Nephew, Inc. Plating System Hexalobular Bone K082516 2008 Screws…
Smith & Nephew, Inc.2008—
*K083032Peri-Loc Bone Plating and Screw System
Summary page 4
…2008 Screws PERI-LOC Bone Plating and Screw Smith & Nephew, Inc. K083032 January 7, 2009 System Modified Distal Radius Plating Biomet…
Smith & Nephew, Inc.20092
*K133939Modified Distal Radius Plating System
Summary page 4
…7, 2009 System Modified Distal Radius Plating Biomet Trauma K133939 April 1, 2014 System Device Description The VLP Wrist Fracture System is a radial plating…
Biomet20142

Also cleared against K132296: 3 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
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

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 20 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • 13 of the 46 ancestors have a recall of any class.
  • Of its descendants, K181533 (Smith & Nephew, Inc., 2018) has gone furthest, with 9 descendants of its own.
  • 3 other devices also cite its predicate K132296.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and ostcotomics involving the radius.

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 K132296

3 other devices cite the same predicate.

  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip…Smith & Nephew, Inc. · 20221 recall
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 20211 recall
  • 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/K161665 · printed Nov 5, 2026

Cite this page

510(k) Report. “K161665: VLP Wrist Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161665

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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