510(k) · Cleared
ClearedSmith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories
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 Jun 4, 2009 as substantially equivalent to K060736 (Smith & Nephew, Inc., 2006) and 6 other predicates after an 83-day review. Its family tree reaches back 8 generations to 1996. 1 of the 533 devices in its family, counting itself, has a Class I recall. 487 later devices descend from it.
- Decided
- Jun 4, 2009
- Review
- 83 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K962616 (1996). 45 ancestors in all, the oldest K792022 (1979). 487 later devices descend from it, 23 citing it directly. 1 of the 533 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- This deviceK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · cites it directly · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · cites it directly · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 2 generations on · 76 of its ownK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
Showing 5 of 487 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 487 · See all- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · cites it directly228descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · cites it directly161descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 2 generations on118descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · cites it directly79descendants
- K120070Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · 2 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +1 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +1 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +2 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
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 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 10 | 0 |
| 2013 | 7 | 0 |
| 2014 | 19 | 0 |
| 2015 | 24 | 0 |
| 2016 | 12 | 0 |
| 2017 | 35 | 0 |
| 2018 | 20 | 0 |
| 2019 | 27 | 0 |
| 2020 | 34 | 0 |
| 2021 | 43 | 1 |
| 2022 | 33 | 0 |
| 2023 | 41 | 0 |
| 2024 | 58 | 0 |
| 2025 | 51 | 0 |
| 2026 | 67 | 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.
1 device in this family has a Class I recall. 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? (8)
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 |
|---|---|---|---|
| * | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSummary page 2…cessories Description 51 O(k) Clearance Date Smith & Nephew 6.5mm and 8.0mm Cannulated K060736 4/18/06 Screws Synthes 2.,4mm Cannulated Screw KO12945 12/03/2001… | 2006 |
| * | K012945 | Synthes 2.4 MM Cannulated Screw | 2001 |
| * | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSummary page 2…Screws Synthes 2.,4mm Cannulated Screw KO12945 12/03/2001 Synthes 3.0mm Cannulated Screw K962823 10/01/96 Synthes 3.0mm Headless Compression Screw K050636 4/21/05 DePuy FRS S… | 1996 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 2…12/03/2001 Synthes 3.0mm Cannulated Screw K962823 10/01/96 Synthes 3.0mm Headless Compression Screw K050636 4/21/05 DePuy FRS Screw K062352 10/19/2006 Smith & Ne… | 2005 |
| * | K062352 | FRS ScrewSummary page 2…10/01/96 Synthes 3.0mm Headless Compression Screw K050636 4/21/05 DePuy FRS Screw K062352 10/19/2006 Smith & Nephew K-Wires Pre-amendment device PERI-LOC… | 2006 |
| * | K071563 | Peri-Loc Periarticular Locked Plating SystemSummary page 2…10/19/2006 Smith & Nephew K-Wires Pre-amendment device PERI-LOC Periarticular Locked Plating System VLP K071563 K07163 ! 8/8/2007 Plates/Screws Smith & N… | 2007 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 2…K07163 ! 8/8/2007 Plates/Screws Smith & Nephew Locking Bone Plate System Peri- K033669 12/10/2003 articular Plates Summary of Safely Effectiveness.doc DEPARTMENT OF HEALTH & HUMA… | 2003 |
| * | — | Smith & Nephew K-Wires Named without a submission number |
What descends from it? (487)
See all 48723 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | 2010 | 228 |
| K111994 | Smith & Nephew Cannulated Screws and Washers | 2011 | 161 |
| K143039 | CrossRoads Screw System | 2015 | 79 |
| K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws… | 2011 | 69 |
| K093047 | Smith & Nephew Circular Fixation System | 2010 | 51 |
| K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System | 2014 | 46 |
| K124027 | Monster Screw System | 2013 | 41 |
| K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | 2013 | 33 |
| K140814 | Evos Mini-Fragment Plating System | 2014 | 32 |
| K131722 | I.T.S. Extremity Fixation Systems | 2013 | 24 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 45 ancestors have a recall of any class.
- Of its descendants, K100776 (Synthes (Usa), 2010) has gone furthest, with 228 descendants of its own.
- 9 other devices also cite its predicate K060736.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 VLP FOOT Plating, Screw System and Accessories is indicated for the following: 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 the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot.…
Read the full statement (169 words)
The VLP FOOT Plating, Screw System and Accessories is indicated for the following:
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 the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot.
The Smith & Nephew 2.5mm, 3.0mm Cannutated 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.
Pins and wires are indicated for pelvic, small and long bone fracture fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090675: Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090675
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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