(141 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical bench tests and finite element analysis, not studies related to AI/ML performance metrics.
No
This device is an internal fixation plating system used for fracture fixation, arthrodesis, reconstruction, replantation, or reduction of bones, which are structural and mechanical interventions rather than therapeutic treatments.
No
The device is an internal fixation plating system used for fracture fixation, arthrodesis, reconstruction, replantation, or reduction of small bones and small bone fragments. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is an internal fixation plating system comprised of implantable bone plates, screws, and washers made from titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is an implantable internal fixation system used for fracture fixation, arthrodesis, reconstruction, replantation, and reduction of bones. It is surgically implanted into the body.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are intended for use in internal fixation of small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
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 small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The subject Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is an internal fixation plating system comprised of assorted small. implantable utility locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones. Plates consist of groups of devices with a flat cross-section and others with a radiused cross-section where of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade titanium alloy material and will be available in a sterile packaged condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones, small bone fragments, long bones
Indicated Patient Age Range
adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench (mechanical) testing was conducted on bone plates and screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices described above. The specific type of non-clinical testing conducted is described as:
- . Finite element analysis (FEA) of bone plates to predict the worst-case plate for subsequent nonclinical bench (mechanical) testing
- Four-point bend fatigue testing of bone plates and bone screws .
- Torque-to-failure testing of bone screws .
- Axial pull-out testing of bone screws .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K993106, K090675, K083032, K060736, K062216, K063049, K051567, K101240, K061748
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary of Safety and Effectiveness FEB - 4 2014
Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 27, 2013 |
| Contact Person: | David Henley, Regulatory Affairs Project Manager
Tel: (901) 399-6487 Fax: (901) 566-7079 |
| Proprietary Name: | Smith & Nephew Variable-Angle Locking
Mini-Fragment Plating System |
| Common Name: | Bone Plates, Bone Screws and Washers |
| Classification Name and Reference: | 21 CFR 888.3030, Single/multiple component metallic
bone fixation appliances and accessories - Class 2 |
| | 21 CFR 888.3040, Smooth or threaded metallic bone
fixation fastener - Class 2 |
| Device Product Code and Panel Code: | HRS / HWC / HTN Orthopedics / 87 |
Device Description:
The subject Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System is an internal fixation plating system comprised of assorted small. implantable utility locking bone plates and compatible locking and non-locking bone screws and washers to be used on various small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones. Plates consist of groups of devices with a flat cross-section and others with a radiused cross-section where of holes in plates will range from 4 through 20. All described implant devices are manufactured from implant-grade titanium alloy material and will be available in a sterile packaged condition.
Intended Use:
Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are intended for use in internal fixation of small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
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 small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Page 1 of 2
1
Implantable bone plates, bone screws and washers from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
Technological Characteristics:
Device comparisons described in this premarket notification demonstrated that the proposed bone plates, bone screws and washers are substantially equivalent to the legally marketed predicate devices (listed below) with regard to intended use, indications for use, materials and performance characteristics.
Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based similar intended use, indications for use, raw materials, operating principles and design/performance characteristics.
- Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) K993106 .
- VLP Foot Plating and Screw System K090675 .
- PERI-LOC (Titanium) Bone Plating and Screw System K083032 .
- Smith & Nephew 6.5mm and 8.0mm Cannulated Screws K060736 .
- PERI-LOC B-Plate Locking Bone Plates and Screws K062216 .
- Synthes Modular Mini Fragment LCP System K063049 .
- Medartis APTUS Titanium System K051567 ♥
- DePuy ALPS Small Bone Locked Plating System K101240 .
- Hand Innovations LLC, Mini Fragment Plates K061748 .
Non-clinical Testing:
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on bone plates and screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System. Test results demonstrated that the proposed devices are substantially equivalent to one or more of the previously cleared predicate devices described above. The specific type of non-clinical testing conducted is described as:
- . Finite element analysis (FEA) of bone plates to predict the worst-case plate for subsequent nonclinical bench (mechanical) testing
- Four-point bend fatigue testing of bone plates and bone screws .
- Torque-to-failure testing of bone screws .
- Axial pull-out testing of bone screws .
Page 2 of 2
5-2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
Smith & Nephew, Incorporated Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116
Re: K132886
Trade/Device Name: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System 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, HTN Dated: December 27, 2013 Received: December 30, 2013
Dear Mr. Henley:
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 ffor 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. Iisting 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 '
3
Page 2 – Mr. David Henley
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Vincent到Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
510(k) Number (if known):
Device Name: Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System
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 small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
Components in the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System are for single use only.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (Part 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)
Elizabet铜砂砾rank -S
Division of Orthopedic Devices