(181 days)
No
The device description and performance studies focus on the mechanical properties and performance of the internal fixation plating system, with no mention of AI or ML.
Yes
The device is an internal fixation system for femoral neck fractures, directly treating a medical condition.
No
The device description indicates it is an internal fixation plating system for stabilizing fractures, not for diagnosing conditions. The performance studies also focus on mechanical strength and stability, not diagnostic accuracy.
No
The device description explicitly states it is an "internal fixation plating system comprised of contoured locking bone plates and compatible locking and non-locking bone screws," which are physical hardware components made of stainless steel. The performance studies also focus on the mechanical properties of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the internal fixation of femoral neck fractures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an internal fixation plating system comprised of bone plates and screws. These are implants designed to be surgically placed within the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
This device is clearly an implantable surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
Product codes
JDO, KTT
Device Description
The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck
Indicated Patient Age Range
Not Found
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
- Axial Pullout Strength Evaluation was conducted on the CONQUEST FN Locking screws. Results of the test concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior axial pullout strength compared to the predicate.
- Insertion Torque Performance was conducted on the proposed locking screws. Results of the testing concluded that the CONQUEST FN screws met the acceptance criteria and exhibited similar or superior insertion torque performance compared to the predicate.
- Removal Torque Performance was conducted on the CONQUEST FN Locking screws. Results of the test concluded that the subject device met the acceptance criterion and is expected to have acceptable torsional performance with regard to removal torque.
- Torsional Strength Evaluation was conducted on the CONQUEST FN Locking Screws. Results of the test concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior torsional strength compared to the predicate.
- Construct Fatigue Testing was conducted on the CONQUEST FN System. Results of the test concluded that the CONQUEST FN system met the acceptance criteria and is expected to have similar construct stability during fatigue as compared to the predicate.
- Construct Fatigue Evaluation of the CONQUEST FN System as compared to Three Cannulated Screws in a Simulated Femoral Neck Fracture Model. Results of the test concluded that the CONQUEST FN System met the acceptance criteria and exhibited similar or superior construct fatigue as compared to the predicate.
- Construct Fatigue Evaluation was conducted on the one hole CONQUEST FN locking plate as compared to Three Cannulated Screw. Results of the test concluded that the CONQUEST FN one hole locking plate met the acceptance criteria by having at least similar or superior construct fatigue performance as compared to 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2016
Smith & Nephew, Incorporated Bradley Heil Regulatory Affairs Manager 1450 East Brooks Road Memphis, Tennessee 38116
Re: K152686 Trade/Device Name: CONQUEST FN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDO, KTT Dated: February 16, 2016 Received: February 18, 2016
Dear Mr. Heil:
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
1
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K152686
Device Name CONQUEST FN
Indications for Use (Describe)
The Smith & Nephew CONQUEST FN is indicated for displaced intracapsular femoral neck fractures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Image /page/3/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.
| Submitted by: | Smith & Nephew, Inc.
Advance Surgical Devices Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | March 15, 2016 |
| Contact Person and Address: | Bradley Heil
Regulatory Affairs Manager
T (901) 399-6339
F (901) 566-7831 |
| Name of Device: | CONQUEST FN |
| Common Name: | Internal Fracture Fixation Device |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic bone
fixation appliances and accessories
Class II |
| Panel Code: | Orthopedics/87 |
| Product Code: | JDO, KTT |
Device Description
The subject premarket notification describes the Smith & Nephew CONQUEST FN. The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.
Intended Use
CONQUEST FN is intended for use in internal fixation of femoral neck fractures
Indications for Use
The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
Technological Characteristics
Device comparisons described in this premarket notification demonstrated that the proposed CONQUEST FN implants are substantially equivalent to the legally marketed predicate devices listed below with regard to intended use, indications for use, and performance characteristics. The subject CONQUEST FN features characteristics very similar to the Targon FN cleared via K102057, with the primary differences being material changes and the utilization of POGO Screw technology (K080649). To accommodate for differences between the subject device and the predicate cleared via K102057, mechanical testing was conducted to compare the two devices.
Substantial Equivalence Information
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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 |
|----------------------------------|-------------------------------------------------|----------------------|-------------------|
| Aesculap Implant
Systems, LLC | Targon FN System (Primary Predicate) | K102057 | 12/21/10 |
| FxDevices | POGO Screw | K080649 | 11/25/08 |
| Smith & Nephew | Smith & Nephew Cannulated Screws and
Washers | K111994 | 10/11/2011 |
Table 1: Substantially Equivalent Predicates to CONQUEST FN
Summary of Pre-Clinical Testing
- Axial Pullout Strength Evaluation was conducted on the CONQUEST FN Locking screws. Results of the test concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior axial pullout strength compared to the predicate.
- . Insertion Torque Performance was conducted on the proposed locking screws. Results of the testing concluded that the CONQUEST FN screws met the acceptance criteria and exhibited similar or superior insertion torque performance compared to the predicate.
- . Removal Torque Performance was conducted on the CONQUEST FN Locking screws. Results of the test concluded that the subject device met the acceptance criterion and is expected to have acceptable torsional performance with regard to removal torque.
- Torsional Strength Evaluation was conducted on the CONQUEST FN Locking Screws. ● Results of the test concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior torsional strength compared to the predicate.
- . Construct Fatigue Testing was conducted on the CONQUEST FN System. Results of the test concluded that the CONQUEST FN system met the acceptance criteria and is expected to have similar construct stability during fatigue as compared to the predicate.
- Construct Fatigue Evaluation of the CONQUEST FN System as compared to Three Cannulated Screws in a Simulated Femoral Neck Fracture Model. Results of the test concluded that the CONQUEST FN System met the acceptance criteria and exhibited similar or superior construct fatigue as compared to the predicate.
- Construct Fatigue Evaluation was conducted on the one hole CONQUEST FN locking plate as compared to Three Cannulated Screw. Results of the test concluded that the CONQUEST FN one hole locking plate met the acceptance criteria by having at least similar or superior construct fatigue performance as compared to the predicate.
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Conclusion
This 510(k) premarket notification is being submitted to request clearance for CONQUEST FN. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate systems listed in Table 1.