(98 days)
No
The document describes a system of bone plates and screws for fracture fixation and does not mention any AI or ML components or functionalities.
Yes
The device is a surgical implant (plates and screws) used to stabilize and fix bone fractures, which directly treats a medical condition.
No
Explanation: The device is described as a system of locking bone plates and screws indicated for the treatment of femoral neck fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is comprised of "contoured locking bone plates and compatible locking and non-locking bone screws" made of "implant-grade stainless steel," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating bone fractures (displaced and undisplaced intracapsular femoral neck fractures). This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is comprised of bone plates and screws, which are implants used to stabilize bone fractures. This is a medical device used in vivo (within the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to repair a physical injury.
N/A
Intended Use / Indications for Use
The Smith & Nephew Conquest FN is indicated for displaced intracapsular femoral neck fractures.
Product codes
JDO, KTT
Device Description
The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional lengths of the proximal locking compression screws to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- OR-17-111: Axial Pullout Strength Evaluation was conducted on the CONQUEST FN proximal locking compression screws as compared to the Targon FN Titanium System. 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 device.
- OR-17-164: Axial Pullout Strength Evaluation was conducted on the CONQUEST FN . proximal locking compression screws as compared to the cannulated screws. Results of the test concluded that the CONQUEST FN proximal locking screws met the acceptance criteria and exhibited similar or superior axial pullout strength as compared to the predicate device.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K152686, K111994, K102057, K080649
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.
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December 22, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew Allison Chan Regulatory Affairs Specialist II 1450 E Brooks Road Memphis, Tennessee 38116
Re: K172785
Trade/Device Name: CONOUEST 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: December 11, 2017 Received: December 12, 2017
Dear Ms. Chan:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
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3
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| Submitted by: | Smith & Nephew, Inc.
Advance Surgical Devices Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Date of Summary: | December 11,2017 |
| Contact Person and Address: | Allison Chan
Regulatory Affairs Specialist II
T (901) 399-1098
F (901) 566-7022 |
| 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 CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional lengths of the proximal locking compression screws to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same 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
The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
Comparison to Technological Characteristics with Predicate Device
Device comparisons described in this premarket notification demonstrated that the proposed CONQUEST FN proximal locking compression screws are substantially equivalent to the legally marketed predicate devices listed below with regard to intended use, indications for use, and performance characteristics.
The subject proximal locking compression screws features characteristics very similar to the CONQUEST FN system proximal locking compression screws cleared via K152686, with the primary differences being shorter overall screw length and minor thread length differences. All other design aspects, indications for use, intended use, material and fundamental scientific technology remain the same as those in K152686.
4
Summary of Pre-Clinical Testing
- o OR-17-111: Axial Pullout Strength Evaluation was conducted on the CONQUEST FN proximal locking compression screws as compared to the Targon FN Titanium System. 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 device.
- OR-17-164: Axial Pullout Strength Evaluation was conducted on the CONQUEST FN . proximal locking compression screws as compared to the cannulated screws. Results of the test concluded that the CONQUEST FN proximal locking screws met the acceptance criteria and exhibited similar or superior axial pullout strength as compared to the predicate device.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.
Substantial Equivalence Information
The substantial equivalence of the CONQUEST FN proximal locking compression screws is based on its similarities in indications for use, design features, sterilization methods, and materials to the predicate systems listed in the following table.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------------------|--------------------------------|----------------------|-------------------|
| Smith & Nephew | CONQUEST FN(Primary Predicate) | K152686 | 3/17/2016 |
| Smith & Nephew | Cannulated Screws and Washers | K111994 | 10/11/2011 |
| Aesculap Implant
Systems, LLC | Targon FN System | K102057 | 12/21/2010 |
| FxDevices | POGO Screw | K080649 | 11/25/2008 |
Table 5.1: Substantially Equivalent Predicates to CONQUEST FN Proximal Locking Compression Screws