510(k) Report

510(k) · Cleared

Cleared

VLP Mini-Mod Talus Plates

K152976510(k) SpecialCleared Nov 12, 201535-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 12, 2015 as substantially equivalent to K110670 (Smith & Nephew, Inc., 2011) and 3 other predicates after a 35-day review. Its family tree reaches back 11 generations to 2001. 8 later devices descend from it.

Decided
Nov 12, 2015
Review
35 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
4

Its longest line of descent runs back 11 generations to K010612 (2001). 112 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2007: 3 other ancestors1999: 4 other ancestors2010: 1 other ancestor2009: 3 other ancestors2008: 3 other ancestors2006: 9 other ancestors2005: 8 other ancestors2003: 5 other ancestors2002: 11 other ancestors2004: 6 other ancestors2001: 12 other ancestors2000: 11 other ancestors1996: 6 other ancestors1990: 1 other ancestor1998: 7 other ancestors1995: 2 other ancestors1994: 1 other ancestor1993: 2 other ancestors1992: 1 other ancestor1991: 1 other ancestor1989: 2 other ancestors1979: 1 other ancestor2022: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2023: 2 descendants cleared2026: 2 descendants clearedK010612 · Vectorvision Knee · Brainlab AG · 2001K021306 · Vectorvision CT-Free Knee · Brainlab AG · 2002K040368 · Vectorvision Hip 3.0 · Brainlab AG · 2004×2: 2 generations cleared close together, K052213 (2005), K060468 (2006) K070731 · Pigalileo Total Hip Replacement (THR) System · Plus Orthopedics AG · 2007K080875 · Pigalileo 4TH Generation System · Smith & Nephew, Inc. · 2008×3: 3 generations cleared close together, K090420 (2009), K092497 (2009), K100107 (2010) K110670 · VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates · Smith & Nephew, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 12 other ancestors3 generations back: 28 other ancestors4 generations back: 26 other ancestors5 generations back: 19 other ancestors6 generations back: 8 other ancestors7 generations back: 3 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K110670 · VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates · Smith & Nephew, Inc. · 2011K100107 · Smith & Nephew Sureshot Distal Targeting System V2.0 · Smith & Nephew, Inc. · 2010 · recalledK092497 · Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 · Smith & Nephew, Inc. · 2009K090420 · Smith & Nephew Pigalileo Screw Targeting System V 1.0 · Smith & Nephew, Inc. · 2009K080875 · Pigalileo 4TH Generation System · Smith & Nephew, Inc. · 2008K070731 · Pigalileo Total Hip Replacement (THR) System · Plus Orthopedics AG · 2007K060468 · Vectorvision Hip · Brainlab AG · 2006K052213 · Navigation SW Hip 3.1 on CI · Brainlab AG · 2005K040368 · Vectorvision Hip 3.0 · Brainlab AG · 2004K021306 · Vectorvision CT-Free Knee · Brainlab AG · 2002K010612 · Vectorvision Knee · Brainlab AG · 2001−10−50
  1. Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
  2. 7 generations between
  3. 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
  4. 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
  5. 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
  6. This deviceK152976 VLP Mini-Mod Talus PlatesSmith & Nephew, Inc. · 2015
  7. Descendant · cites it directly · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
  8. Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
  9. Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
  10. Descendant · 3 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
  11. Descendant · 2 generations on · 0 of its ownK253713 Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026
Show all 11 generations
  1. Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
  2. 10 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
  3. 9 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
  4. 8 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
  5. 7 generations backK060468 Vectorvision HipBrainlab AG · 2006
  6. 6 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
  7. 5 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
  8. 4 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
  9. 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
  10. 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
  11. 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
  12. This deviceK152976 VLP Mini-Mod Talus PlatesSmith & Nephew, Inc. · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2021: 12022: 12023: 22025: 22026: 2
2021high 2 (2023) · low 0 (2024)2026

Most influential descendants

Showing 5 of 8 · See all
  • 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
  • K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K010612Vectorvision KneeBrainlab AG2001—
−10K021306Vectorvision CT-Free KneeBrainlab AG2002—
−9K040368Vectorvision Hip 3.0Brainlab AG2004—
−8K052213Navigation SW Hip 3.1 on CIBrainlab AG2005—
−7K060468Vectorvision HipBrainlab AG2006—
−6K070731Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG2007—
−5K080875Pigalileo 4TH Generation SystemSmith & Nephew, Inc.2008—
−4K090420Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc.2009—
−3K092497Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc.2009—
−2K100107Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc.20101
−1K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…Smith & Nephew, Inc.2011—
0 (this device)K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.2015—
+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—
+2K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198920
199010
199110
199210
199320
199410
199520
199660
199870
199940
2000110
2001120
2002110
200350
200460
200580
200690
200730
200830
200930
201010
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202320
202520
202620
FIG. 1 — Lineage of K152976, 2001–2026Source: 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? (4)

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
*K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…
Summary page 4
…umber Date VLP FOOT Plating System and PERI-LOC Smith & Nephew, Ankle Fusion Plating System – Locking Bone K110670 7/12/11 Inc. Plates and Screws (Primary Predicate) Smith & Nephew, Smith & Nephew Variable-An…
Smith & Nephew, Inc.2011—
*K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System
Summary page 4
…es and Screws (Primary Predicate) Smith & Nephew, Smith & Nephew Variable-Angle Locking K132886 2/4/14 Inc. Mini-Fragment Plating System Synthes (USA) 2.4/2.7mm Locking Foot Synt…
Smith & Nephew, Inc.20142
*K071264Synthes (Usa) 2.4/2.7 MM Locking Foot Module
Summary page 4
…Mini-Fragment Plating System Synthes (USA) 2.4/2.7mm Locking Foot Synthes (USA) K071264 7/9/2007 Module Smith & Nephew, Smith & Nephew Bone Plate System (Bone…
Synthes (Usa)2007—
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 4
…07 Module Smith & Nephew, Smith & Nephew Bone Plate System (Bone K993106 12/9/1999 Inc. Plates, Bone Screws, and Accessories) Device Description The subject premarket notification…
Smith & Nephew, Inc.1999—

Also cleared against K110670: 8 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
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 14 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
  • 26 of the 112 ancestors have a recall of any class.
  • Of its descendants, K210837 (Smith & Nephew, Inc., 2021) has gone furthest, with 7 descendants of its own.
  • 8 other devices also cite its predicate K110670.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Mini-Mod Talus Plates 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 Mini-Mod Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.

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 K110670

8 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
  • K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc · 20141 recall
  • K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc · 2014
  • K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation · 20146 recalls
  • K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH · 20132 recalls

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/K152976 · printed Nov 5, 2026

Cite this page

510(k) Report. “K152976: VLP Mini-Mod Talus Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152976

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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