510(k) · Cleared
ClearedVLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion Plates, Peri-Loc 3.5MM Hindfoot
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 Apr 4, 2012 as substantially equivalent to K110670 (Smith & Nephew, Inc., 2011) after a 30-day review. Its family tree reaches back 11 generations to 2001. 9 later devices descend from it.
- Decided
- Apr 4, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010612 (2001). 89 ancestors in all, the oldest K792022 (1979). 9 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 7 generations between
- 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- This deviceK120667 VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM…Smith & Nephew, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
- Descendant · cites it directly · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253713 Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 10 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 9 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 8 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 7 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 6 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 5 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 4 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- This deviceK120667 VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM…Smith & Nephew, Inc. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −10 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −9 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −8 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −7 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −6 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −5 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −4 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −3 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −1 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K120667 | VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior… | Smith & Nephew, Inc. | 2012 | — |
| +1 | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | 1 |
| +1 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
| +3 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | — |
| +2 | K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | 2026 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Summary page 2…nological Characteristics: The PER]-LOC Ankle Fusion Plates and VLP Extra Large Percutaneous Calcaneus Plate are very similar to legally marketed devices cleared under K1 10670. When compared to the predicates from K1 10670, the proposed devices share identical indications for use and intended use, are… | 2011 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 20 of the 89 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 devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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 Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent…
Read the full statement (123 words)
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 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.
PERI-LOC Ankle Fusion Bone Plates and the VLP Extra Large Percutaneous Calcaneus Plate are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120667 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120667: VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion Plates, Peri-Loc 3.5MM Hindfoot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120667
Report an extraction error
Are you the manufacturer?
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