(83 days)
Not Found
Not Found
No
The document describes a traditional bone plate and screw system for fracture fixation and does not mention any AI or ML components.
Yes
The device is described as a bone plate system used for fracture fixations, which is a treatment for injuries, thus qualifying it as a therapeutic device.
No
The device is a bone plate system used for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states it includes "Bone Plates, Bone Screws, and Accessories," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical fixation of bone fractures. This is a direct intervention on the patient's body.
- Device Description: The description mentions "implants" like bone plates and screws, which are physical devices inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these specimens.
Therefore, the Smith & Nephew Bone Plate System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
87HRS, 87HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small, and long bone (including tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; calcaneal)
Indicated Patient Age Range
adult or pediatric patients
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)
Not Found
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.
Not Found
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 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 (bone |
| plates, 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 fixation | |
| appliances and accessories | |
| Title 21 CFR 888.3040 (Screws) | |
| Smooth or threaded metallic bone fixation | |
| fastener | |
| Device Class: | |
| Device Product Code and Panel Code: | Class II |
| 87HRS - Plate | |
| 87HWC - Screw | |
| Panel: 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
1
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.
2
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
3
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__________________________________________________________________________________________________________________________________________________________