(50 days)
Not Found
No
The 510(k) summary describes a mechanical bone screw system and does not mention any software, algorithms, or AI/ML capabilities. The testing focuses on mechanical properties.
Yes
The device is a bone screw system indicated for treating bone fractures, osteotomies, arthrodesis, osteochondritis, and tendon reattachment, which are all conditions that require therapeutic intervention.
No
The device description indicates it is a surgical implant (cannulated bone screw) used for bone fractures and tendon reattachment, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a system of implants (screws), which are physical hardware components. There is no mention of software as the primary or sole component.
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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "cannulated bone screw" intended for surgical implantation to fix bone fractures, arthrodeses, osteochondritis, and tendon reattachment. It is a physical implant used directly within the body.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and structural within the body.
Therefore, the CSS cannulated bone screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CSS cannulated bone screw is indicated for bone fractures, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Cannulated Screw System implants are partially threaded devices offered in multiple lengths and diameter. The implants have a cruciate driver head. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. These screws are of self-tapping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures; not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
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)
Testing rationales related to pull out, insertion, removal and ultimate torque were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system.
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.
K042310: Cannulated Bone Screws System, K082320: Wright Compression Screws
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. Ms. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis, Tennessee 38117
January 23, 2015
Re: K143460
Trade/Device Name: Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 10, 2014 Received: December 11, 2014
Dear Ms. Tara Conrad:
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
1
Page 2 - Ms. Tara Conrad
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Cannulated Screw System
Indications for Use (Describe)
The CSS cannulated bone screw is indicated for bone fractures, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Headquarters Wright Medical Technology, Inc
Memphis, TN 38117
1867 9971 mt.com
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Cannulated Screw System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|-------------------------------------------------------------------------------------------------|
| Date: | December 22, 2014 |
| Contact Person: | Tara Conrad
Regulatory Affairs Specialist
Office - (901) 867-4367
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | Cannulated Screw System |
| Common Name: | Smooth or threaded metallic bone fixation
fastener |
| Classification Name and Reference: | 21 CFR 888.3040 – Class II |
| Device Product Code, Device Panel: | HWC - Orthopedic |
| (a)(3). Predicate Device: | K042310: Cannulated Bone Screws System
K082320: Wright Compression Screws |
(a)(4). Device Description
The Cannulated Screw System implants are partially threaded devices offered in multiple lengths and diameter. The implants have a cruciate driver head. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. These screws are of self-tapping.
(a)(5). INTENDED USE
The Cannulated Screw System is designed for bone fracture, osteotomies, arthrodesis, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
(a)(6). Technological Characteristics Comparison
The Cannulated Screw System and the legally marketed predicate devices have similar indications, dimensions and geometry, and materials. The Cannulated Screw System is technologically substantially equivalent to the predicate devices.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
4
Testing rationales related to pull out, insertion, removal and ultimate torque were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system.
The safety and effectiveness of the Cannulated Screw System is adequately supported within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.