(56 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of bone plates and screws, with no mention of AI or ML.
Yes
The device is indicated for fracture fixation and reconstruction of small bones and fragments, which are therapeutic interventions.
No
The device is an orthopedic implant system (plates and screws) used for fracture fixation, arthrodesis, reconstruction, replantation, or reduction of small and long bones and fragments. It is not designed to diagnose medical conditions but rather to treat them structurally.
No
The device description explicitly states that the system is comprised of "assorted implantable, locking bone plates and compatible locking and non-locking bone screws," which are physical hardware components made of titanium alloy. The performance studies also describe mechanical testing of these physical implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a system of bone plates and screws designed for surgical implantation to fix fractures, perform arthrodesis, reconstruction, replantation, or reduction of bones. This is an implantable medical device used directly on the patient's body, not for testing specimens outside the body.
The information provided focuses on the mechanical properties, materials, and surgical applications of the device, which are characteristic of implantable orthopedic devices, not IVDs.
N/A
Intended Use / Indications for Use
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for nonload bearing stabilization and reduction of bone fragments in long bones.
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
Product codes
HRS, HWC
Device Description
The subject premarket notification describes 1.5mm line additions to the VLP Mini-Mod Small Bone Plating System. The subject internal fixation plating system is comprised of assorted implantable, locking bone plates and compatible locking and non-locking bone screws to be used on various small bones and fragments. The VLP Mini-Mod Small Bone Plating System is a subset of the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, which was previously cleared via Traditional 510(k) K132886. Subject plates consist of groups of devices with a radiused cross-section where the number of holes in the plates will range from 6 through 24. Specific plate designs include Y-plates, Straight plates, and Column plates. All described implant devices are manufactured from implant-grade titanium alloy material (Ti-6Al-4V) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation. Bone screws will be offered in both locking and non-locking options in a variety of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones and fragments, long bones
Indicated Patient Age Range
adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Finite element analysis (FEA) was conducted on the proposed 1.5mm bone plate designs to determine the worst case plate as well as the high stress region of the plate to be used for subsequent mechanical testing. The acceptance criteria was met in that the subject bone plates exhibited similar or superior structural strength compared to the existing 1.5mm predicates. Results of the FEA demonstrated that the plates identified for mechanical testing were the appropriate bone plates because they possessed the highest stress concentrations.
- Four-point bend fatigue testing was conducted on worst-case examples of the proposed bone plates, as identified through FEA testing. Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate.
- Torque-to-failure testing for the proposed 1.5mm bone screws was conducted per the guidelines of ASTM F543-07. The acceptance criterion was met in that all tested 1.5mm screws met the minimum torsional strength requirement dictated by ASTM F543-07.
- Axial pull-out testing was conducted on the subject 1.5mm cortex screws following the guidelines set forth in ASTM F543 with maximum force denoted as pull-out strength. The subject implants met the acceptance criteria in that the maximum pullout force of the subject screws was non-inferior to the maximum pull-out force of the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three overlapping profiles, suggesting a sense of community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Smith & Nephew, Inc. Ms. Samantha Staubach Regulatory Affair Specialist I 1450 Brooks Road Memphis. Tennessee 38116
Re: K143050
Trade/Device Name: VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 22, 2014 Received: October 23, 2014
Dear Ms. Staubach:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
1
Page 2 - Ms. Samantha Staubach
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification Indications for Use Statement
K143050 510(k) Number (if known):
Device Name: VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
Indications for Use:
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and fragments. This system is also indicated for nonload bearing stabilization and reduction of bone fragments in long bones.
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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Image /page/3/Picture/0 description: The image contains the logo for Smith & Nephew. The logo features an orange flower-like symbol to the left of the text. The text reads "We are smith&nephew", with "We are" in black and "smith&nephew" in orange.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 22, 2014 |
| Contact Person and Address: | Samantha Staubach
Regulatory Affairs Specialist I
T (901) 399-6132
F (901) 566-7596 |
| Name of Device: | Smith & Nephew, Inc. VLP Mini-Mod Small Bone Plating
System 1.5mm Plates and Screws |
| Common Name: | Bone Plates and Screws |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories
Class II |
| | 21 CFR 888.3040 Smooth or threaded metallic bone fixation
fastener
Class II |
| Panel Code: | Orthopedics/87 |
Device Description
The subject premarket notification describes 1.5mm line additions to the VLP Mini-Mod Small Bone Plating System. The subject internal fixation plating system is comprised of assorted implantable, locking bone plates and compatible locking and non-locking bone screws to be used on various small bones and fragments. The VLP Mini-Mod Small Bone Plating System is a subset of the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System, which was previously cleared via Traditional 510(k) K132886. Subject plates consist of groups of devices with a radiused cross-section where the number of holes in the plates will range from 6 through 24. Specific plate designs include Y-plates, Straight plates, and Column plates. All described implant devices are manufactured from implant-grade titanium alloy material (Ti-6Al-4V) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation. Bone screws will be offered in both locking and non-locking options in a variety of lengths.
Intended Use
Bone plates and bone screws from the VLP Mini-Mod Small Bone Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
4
Indications for Use
The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is indicated for fracture fixation, arthrodesis, reconstruction. replantation or reduction of small bones and fragments. This system is also indicated for nonload bearing stabilization and reduction of bone fragments in long bones.
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
The indications for use for the subject VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws are identical to those previously cleared for the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System.
Technological Characteristics
Device comparisons described in this premarket notification demonstrated that the proposed bone plates and bone screws are substantially equivalent to the legally marketed predicate devices listed below with regard to intended use, indications for use, materials and performance characteristics. The subject VLP Mini-Mod 1.5mm Bone Plates and Screws feature characteristics very similar to the VLP Mini-Mod Small Bone Plating System cleared via K132886, with the primary difference being the 1.5mm size offering. To accommodate for the size difference between the 1.5mm subject plates and the 2.0mm and 2.4mm offerings cleared via K132886, mechanical testing was conducted against the secondary predicates.
Substantial Equivalence Information
When compared to the predicate devices listed below, substantial equivalence is based upon similar function, intended use, indications for use and overall design to the devices listed in the table below.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------|----------------------------------------------------------------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | Smith & Nephew Variable-Angle Locking
Mini-Fragment Plating System (Primary
Predicate) | K132886 | 2/4/14 |
| Synthes (USA) | Synthes (USA) 1.5mm Mini Fragment LCP
System | K090047 | 4/1/09 |
| Smith & Nephew, Inc. | Smith & Nephew Bone Plate System | K993106 | 12/9/99 |
Table 1: Substantially Equivalent Predicates to the VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
5
Summary of Pre-Clinical Testing
- Finite element analysis (FEA) was conducted on the proposed 1.5mm bone plate o designs to determine the worst case plate as well as the high stress region of the plate to be used for subsequent mechanical testing. The acceptance criteria was met in that the subject bone plates exhibited similar or superior structural strength compared to the existing 1.5mm predicates. Results of the FEA demonstrated that the plates identified for mechanical testing were the appropriate bone plates because they possessed the highest stress concentrations.
- o Four-point bend fatigue testing was conducted on worst-case examples of the proposed bone plates, as identified through FEA testing. Results of the testing concluded that the number of log cycles to failure achieved by the proposed bone plates met the acceptance criteria in that they were found to be non-inferior to the fatigue log cycles to failure of a previously cleared predicate.
- Torque-to-failure testing for the proposed 1.5mm bone screws was conducted per the o guidelines of ASTM F543-07. The acceptance criterion was met in that all tested 1.5mm screws met the minimum torsional strength requirement dictated by ASTM F543-07.
- o Axial pull-out testing was conducted on the subject 1.5mm cortex screws following the guidelines set forth in ASTM F543 with maximum force denoted as pull-out strength. The subject implants met the acceptance criteria in that the maximum pullout force of the subject screws was non-inferior to the maximum pull-out force of the predicate.
Conclusion
This 510(k) premarket notification is being submitted to request clearance for the VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate plating systems listed in Table 1 on page 5-2.