(83 days)
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. The Smith & Nephew 2.5mm, 3.0mm Cannulated 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.
Subject of this Traditional 510(k) premarket notification is Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories. The system is comprised of a variety of Cannulated Screws, Headless Cannulated Screws, QFX Screws, K-Wires, Cortex Screws, Locking Cortex Screws, Fully and Partially Threaded Osteopenia Screws, Locking Osteopenia Screws and a variety of VLP FOOT plates.
The provided document is a 510(k) premarket notification for the Smith & Nephew VLP FOOT Plating, Screw System and Accessories. This type of submission is for medical devices that are substantially equivalent to a predicate device, meaning they have the same intended use and similar technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness.
Here’s an analysis of the provided information in relation to acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance:
Acceptance Criterion (Implicit) Reported Device Performance Substantial Equivalence: Demonstrate equivalence in indications for use, design, operational principles, and material composition to legally marketed predicate devices. The device's indications for use: "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 Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bone fragments; arthrodeses of small joints; bunionectomies; 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." The document lists several predicate devices (e.g., Smith & Nephew 6.5mm and 8.0mm Cannulated Screws K060736, Synthes 2.4mm Cannulated Screw K012945, Synthes 3.0mm Cannulated Screw K962823, Synthes 3.0mm Headless Compression Screw K050636, DePuy FRS Screw K062352, Smith & Nephew K-Wires (Pre-amendment device), PERI-LOC Periarticular Locked Plating System VLP Plates/Screws K071563, Smith & Nephew Locking Bone Plate System Periarticular Plates K033669). The FDA's clearance letter confirms a "substantial equivalence" determination. Mechanical Performance: Components capable of withstanding expected in vivo loading without failure. "A review of the mechanical testing data indicates that the implant components of the VLP FOOT Plating, Screws and Accessories are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." Safety: No new questions of safety raised by differences from predicate devices. The FDA's substantial equivalence determination implies that no new questions of safety were raised. Effectiveness: No new questions of effectiveness raised by differences from predicate devices. The FDA's substantial equivalence determination implies that no new questions of effectiveness were raised. Note: For 510(k) submissions, the primary "acceptance criterion" is generally "substantial equivalence" to a legally marketed predicate device. This is demonstrated by showing similar intended use, technological characteristics (including materials and performance), and addressing any differences that might exist.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Mechanical Testing Data" but does not specify sample sizes for testing (e.g., number of implants tested), data provenance (country of origin), or whether the mechanical testing was retrospective or prospective in the sense of clinical studies. It refers to testing on the "implant components." This type of submission relies heavily on bench testing for mechanical properties, not typically clinical trials with patient populations as a "test set." -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This document does not describe a clinical study involving human patients, therefore, there is no "test set" in the context of expert-evaluated clinical data for which ground truth would be established by experts like radiologists. The mechanical testing data would be evaluated by engineers or materials scientists. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this submission does not detail a clinical study requiring expert adjudication of patient data for a test set. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a 510(k) for an orthopedic implant and does not involve AI or human readers evaluating images or cases. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a 510(k) for an orthopedic implant and does not involve an algorithm or AI. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the mechanical testing, the "ground truth" would be established by engineering standards and specifications for implant strength, fatigue life, and other mechanical properties, as well as comparison to the performance of predicate devices. This is typically done through laboratory measurements and calculations, not pathological or clinical outcomes data in the context of a 510(k) for this type of device. -
The sample size for the training set:
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for an orthopedic implant. The design and manufacturing processes are informed by existing biomechanical knowledge, material science, and the performance of predicate devices. -
How the ground truth for the training set was established:
Not applicable, for the reasons stated above.
In summary:
The provided 510(k) documentation focuses on demonstrating substantial equivalence of the VLP FOOT Plating, Screw System and Accessories to existing legally marketed predicate devices, primarily through mechanical testing data and comparison of intended use, design features, operational principles, and material composition. It does not describe a clinical study with human subjects, a test set of patient data, or the use of AI/algorithms that would require expert review or ground truth establishment in the ways typically associated with AI/software medical devices. Mechanical acceptance criteria are met by demonstrating the device can "withstand expected in vivo loading without failure" and is "equivalent to devices currently used clinically."
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K090675 '/2
Summary of Safety and Effectiveness Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories
JUN - 4 2009
Date of Summary: March 11, 2009
Contact Person and Address Jahanvi Agnihotri Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 1 (901) 399-6130
Name of Device: Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories Common Name: Screws, Plates, and K-Wires
Device Classification Name and Reference: 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener – Class II; 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories – Class II Panel Code: Orthopaedics/87 HWC, HRS, HTY
Device Description
Subject of this Traditional 510|k) premarket notification is Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories. The system is comprised of a variety of Cannulated Screws, Headless Cannulated Screws, QFX Screws, K-Wires, Cortex Screws, Locking Cortex Screws, Fully and Partially Threaded Osteopenia Screws, Locking Osteopenia Screws and a variety of VLP FOOT plates.
Mechanical Testing Data
A review of the mechanical testing data indicates that the implant components of the VLP FOOT Plating, Screws and Accessories are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Intended Use
The Smith & Nephew VLP FOOT Plating System can be used in addlescent (12-18 years) and transitional adolescent 118-21 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 Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bone fragments; arthrodeses of small joints; bunionectomies; scaphoid and other carpal bones, metacarpals, farsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Smilh & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteolomies. Osteolomies, fusions and fractures of the phalanges, metacarpals and carpats of the hand. Pins and wires are indicated for pelvic, small and long bone fracture fixation.
Substantial Equivalence Information
The substantial equivalence of the VLP FOOT Plating, Screws System and Accessories is based on its sinilarities in indications for use, design features, operational principles, and material composition to the predicate devices listed in the table below.
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Summary of Safety and Effectiveness Schimary of Safety of Safety of Plating, Screw System and Accessories
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| Description | 510(k) | Clearance Date |
|---|---|---|
| Smith & Nephew 6.5mm and 8.0mm CannulatedScrews | K060736 | 4/18/06 |
| Synthes 2..4mm Cannulated Screw | K012945 | 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 & Nephew K-Wires | Pre-amendment device | |
| PERI-LOC Periarticular Locked Plating System VLPPlates/Screws | K071563 | 8/8/2007 |
| Smith & Nephew Locking Bone Plate System Peri-articular Plates | K033669 | 12/10/2003 |
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consister of the will and and on the
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Ms. Jahanvi Agnihotri 1450 East Brooks Road Memphis, Tennessee 38116
JUN - 4 2009
Re: K090675
Trade/Device Name: Smith & Nephew VLP FOOT Plating, Screw System and Accessories
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and
accessories Regulatory Class: II Product Code: HRS, HWC, HTY Dated: May 13. 2009 Received: May 14, 2009
Dear Ms. Agnihotri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Jahanvi Agnihotri
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buettner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):K090675
Device Name: Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories Indications for Use:
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. The Smith & Nephew 2.5mm, 3.0mm Cannulated 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart Cl
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
Page 1 of 1.
510(k) Number K090675
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.