(83 days)
The Smith & Nephew Bone Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Smith & Nephew Bone Plates, Bone Screws, and Accessories like the predicate devices, include various sizes of implants to accommodate the individual requirements of patient anatomy.
This document is a 510(k) summary for the Smith & Nephew Bone Plate System. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) pathway focuses on demonstrating that the new device has the same intended use and similar technological characteristics as an existing, cleared device, and does not raise new questions of safety or effectiveness.
Here's why the requested information isn't present and what the document does provide:
- Acceptance Criteria and Reported Device Performance: This type of information is typically found in pre-market approval (PMA) applications or de novo submissions, which require clinical data. A 510(k) summary focuses on comparing the new device to a predicate device.
- Sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth, training set sample size, how training set ground truth was established: All of these points relate to a clinical study designed to test the performance of a device against specific metrics. Since this is a 510(k) summary, such a study is not part of the submission process unless the FDA specifically requests it to address new questions of safety or effectiveness, which is not indicated here.
What the document does provide is:
- Device Name: Smith & Nephew Bone Plate System
- Submitter Information: Smith & Nephew, Inc., Orthopaedic Division
- Intended Use: For pelvic, small, and long bone fracture fixation in adult or pediatric patients, including specific bones like tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
- Predicate Devices: Richards Bone Plates and Bone Screws (Smith & Nephew), Osteo* Bone Plates and Bone Screws (Smith & Nephew), Titanium Plates (Synthes), Basic Screw Set (Synthes), ECT Plates and Screws (Zimmer), TiMAX™ Large Fragment System (DePuy), TiMAX™ Bone Screws (DePuy).
- Technological Characteristics: Stated as similar to legally marketed predicate devices, manufactured from similar or like materials, and indicated for similar uses.
- Regulatory Classification: Class II, Product Codes HRS (Plate) and HWC (Screw), Panel: Orthopaedics/87.
- FDA Determination: Substantially equivalent to devices marketed prior to May 28, 1976.
In summary, this document is a regulatory filing for substantial equivalence, not a clinical study report with performance metrics.
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510(k) Summary Smith & Nephew Bone Plate System
| Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901/399-5153 |
| Contact person: | Janet Johnson Green |
| Date summary prepared: | |
| Trade or proprietary device name: | Smith & Nephew Bone Plate System (boneplates, bone screws and accessories) |
| Common or usual name: | Bone Plates, Bone Screws, and Accessories |
| Classification name: | Title 21 CFR 888.3030 (Plates and Accessories)Single/multiple component metallic bone fixationappliances and accessoriesTitle 21 CFR 888.3040 (Screws)Smooth or threaded metallic bone fixationfastener |
| Device Class:Device Product Code and Panel Code: | Class II87HRS - Plate87HWC - ScrewPanel: Orthopaedics/87 |
Substantially Equivalent, Legally Marketed Predicate Devices:
Richards Bone Plates and Bone Screws (Smith & Nephew [i%/a Richards Medical Company]) Osteo* Bone Plates and Bone Screws (Smith & Nephew) Titanium Plates (Synthes) Basic Screw Set (Synthes) ECT Plates and Screws(Zimmer) TiMAX™ Large Fragment System (DePuy) TiMAX™ Bone Screws (DePuy)
Subject device description:
Smith & Nephew Bone Plates, Bone Screws, and Accessories like the predicate devices, include various sizes of implants to accommodate the individual requirements of patient anatomy.
Subiect device intended use:
Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for pelvic, small and long bone fracture fixation.
Smith & Nephew Bone Screws are indicated for long bone fracture fixation.
Smith & Nephew Bone Plates, Bone Screws, and Accessories are for single use only.
Technolocgical Characteristics:
Smith & Nephew Bone Plates, Bone Screws, and Accessories are similar to legally marketed devices listed above in that all of these devices are indicated for pelvic, long, and small bone fracture fixation, are manufactured from similar or like materials, and are similar in technological characteristics.
*Osteo was formerly owned by Smith & Nephew (formerly Richards Medical Company). Smith & Nephew currently distributes devices manufactured by Osteo.
CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and wavy lines representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1999
Ms. Janet Johnson Green, Manager Clinical and Regulatory Affairs Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116
Re: K993106 Trade Name: Smith & Nephew Bone Plate System Regulatory Class: II Product Codes: HRS and HWC Dated: September 16, 1999 Received: September 17, 1999
Dear Ms. Johnson Green:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Johnson Green
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Xumell J. Izen
Ay James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K993106 Device Name: Smith & Nephew Bone Plate System
Indications for Use:
The Smith & Nephew Bone Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Ahmed I. Ayar Sordo
(Division Sign-Off) Division of General Restorative Devices 510(k) Number .
Prescription Use X (Per 21 CFR 601.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.