510(k) · Cleared
ClearedVLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 12, 2011 as substantially equivalent to K090675 (Smith & Nephew, Inc., 2009) and 8 other predicates after a 125-day review. Its family tree reaches back 10 generations to 2001. 69 later devices descend from it.
- Decided
- Jul 12, 2011
- Review
- 125 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 10 generations to K010612 (2001). 88 ancestors in all, the oldest K792022 (1979). 69 later devices descend from it, 9 citing it directly.
- Root · 10 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 6 generations between
- 3 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 2 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 1 generation backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- This deviceK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- Descendant · cites it directly · 53 of its ownK121425 Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012
- Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- Descendant · 2 generations on · 12 of its ownK163650 ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017
- Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · 3 generations on · 9 of its ownK170693 Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 9 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 8 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 7 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 6 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 5 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 4 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 3 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 2 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 1 generation backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- This deviceK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc · 2012 · cites it directly53descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
- K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc · 2017 · 2 generations on12descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
- K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −9 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −8 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −7 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −6 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −5 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −4 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −3 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −2 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −1 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| 0 (this device) | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| +1 | K121425 | Ortholoc 3DI Ankle Fusion Plating System | Wrightmedicaltechnologyinc | 2012 | — |
| +2 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| +2 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | 2017 | — |
| +3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +3 | K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 2 | 0 |
| 2023 | 10 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 8 | 0 |
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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 2…plates, VLP FOOT Percutaneous Calcaneus plates, VLP Bone Screws and PERI-LOC Ankle Fusion plates are very similar to legally marketed devices listed below cleared under K090675, K033669, K9931 06, K071264, K060473, K073375 and K022255. When compared to the predicates, the proposed devices share very simil… | 2009 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 2…VLP FOOT Percutaneous Calcaneus plates, VLP Bone Screws and PERI-LOC Ankle Fusion plates are very similar to legally marketed devices listed below cleared under K090675, K033669, K9931 06, K071264, K060473, K073375 and K022255. When compared to the predicates, the proposed devices share very similar indica… | 2003 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 2…Percutaneous Calcaneus plates, VLP Bone Screws and PERI-LOC Ankle Fusion plates are very similar to legally marketed devices listed below cleared under K090675, K033669, K9931 06, K071264, K060473, K073375 and K022255. When compared to the predicates, the proposed devices share very similar indications for… | 1999 |
| * | K071264 | Synthes (Usa) 2.4/2.7 MM Locking Foot ModuleSummary page 2…us Calcaneus plates, VLP Bone Screws and PERI-LOC Ankle Fusion plates are very similar to legally marketed devices listed below cleared under K090675, K033669, K9931 06, K071264, K060473, K073375 and K022255. When compared to the predicates, the proposed devices share very similar indications for use and i… | 2007 |
| * | K022255 | Modofocation to Synthes Ankle Arthrodesis PlatesSummary page 2…Screws and PERI-LOC Ankle Fusion plates are very similar to legally marketed devices listed below cleared under K090675, K033669, K9931 06, K071264, K060473, K073375 and K022255. When compared to the predicates, the proposed devices share very similar indications for use and intended use, are manufactured… | 2002 |
| * | K060473 | TTC PlateSummary page 2…eus plates, VLP Bone Screws and PERI-LOC Ankle Fusion plates are very similar to legally marketed devices listed below cleared under K090675, K033669, K9931 06, K071264, K060473, K073375 and K022255. When compared to the predicates, the proposed devices share very similar indications for use and intended u… | 2006 |
| * | K073375 | Newdeal Tibiaxys SystemSummary page 2…s, VLP Bone Screws and PERI-LOC Ankle Fusion plates are very similar to legally marketed devices listed below cleared under K090675, K033669, K9931 06, K071264, K060473, K073375 and K022255. When compared to the predicates, the proposed devices share very similar indications for use and intended use, are m… | 2008 |
| * | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Summary page 2…gical design characteristics. The device specific instruments described in this premarket notification are also similar to the identified predicate devices cleared under K092497 and K100107. Substantial Equivalence Information: When compared to the implant and device specific instrument predicate devices… | 2009 |
| * | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0Summary page 2…characteristics. The device specific instruments described in this premarket notification are also similar to the identified predicate devices cleared under K092497 and K100107. Substantial Equivalence Information: When compared to the implant and device specific instrument predicate devices listed below… | 2010 |
What descends from it? (69)
See all 699 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121425 | Ortholoc 3DI Ankle Fusion Plating System | 2012 | 53 |
| K120667 | VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion… | 2012 | 9 |
| K152976 | VLP Mini-Mod Talus Plates | 2015 | 8 |
| K210837 | Smith & Nephew Plates and Screws | 2021 | 7 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP… | 2022 | 2 |
| K140792 | Salvation 3DI Plating System | 2014 | 2 |
| K123347 | Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0 | 2013 | 2 |
| K140408 | Salvation Osteopenic Screw | 2014 | 1 |
| K133930 | Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating Set | 2014 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 20 of the 88 ancestors have a recall of any class.
- Of its descendants, K121425 (Wrightmedicaltechnologyinc, 2012) has gone furthest, with 53 descendants of its own.
- 22 other devices also cite its predicate K090675.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
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 arthrodesis 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…
Read the full statement (125 words)
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 arthrodesis 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, fibula and calcaneus.
VLP FOOT Plating System and PERI-LOC Ankle Fusion Plating System bone plates and bone screws are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110670
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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