(119 days)
Not Found
No
The description focuses on the mechanical properties and materials of bone screws and washers, with no mention of AI or ML capabilities.
No.
This device is intended for the fixation of bone fractures, which is a structural support function rather than an active therapeutic intervention to treat a disease or condition.
No.
The device description and intended use clearly state that the device is for fixation of bone fractures, specifically cancellous screws and washers. There is no mention of diagnostic capabilities, only mechanical fixation and equivalence testing.
No
The device description clearly describes physical hardware components (screws and washers made of stainless steel) and their mechanical properties and testing. There is no mention of any software component.
No, 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 provided text clearly describes the Sonoma Cancellous Screws as implants used for the fixation of bone fractures. They are physical devices surgically implanted into the body to stabilize broken bones.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's condition. Its function is purely mechanical and therapeutic (fixing fractures).
Therefore, based on the provided information, the Sonoma Cancellous Screws are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. 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, HTN
Device Description
Sonoma Cancellous Bone Screws and Washers are a family of stainless steel screws and washers used for various skeletal repairs where cancellous screw thread profiles are clinically desired. The screws are offered in range of diameters from 4mm to 7.3mm, in both cannulated and solid configurations. The screw dimensions including thread profile, thread length, core diameter, cannulation diameter (where applicable), head diameter, overall length, and driving socket size are equivalent to the predicate device. Where applicable, these features are dimensioned as described by ASTM F543-13 (i.e. 4.0mm and 6.5mm solid screws). The washers are sized according to screw diameter and can be used to prevent head subsidence in soft bone. The screws and washers are manufactured from 316 stainless steel per ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures
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)
Engineering analysis and mechanical testing according to ASTM F543-13 in torsional properties and axial pullout testing demonstrate the subject device is substantially equivalent to the predicate device.
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.
K983495 Syntec Bone 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.
0
Image /page/0/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 three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
June 12, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sonoma Orthopedics Products, Incorporated % Ms. Dawn Norman Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133
Re: K150376
Trade/Device Name: Sonoma Cancellous Bone Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: May 1, 2015 Received: May 5, 2015
Dear Ms. Norman:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150376
Device Name
Sonoma Cancellous Bone Screws and Washers
Indications for Use (Describe)
The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary
Sonoma Cancellous Bone Screw and Washer February 12, 2015
Company: Sonoma Orthopedics Products, Inc 1388 Busch Parkway Buffalo Grove, IL 60089 707-526-1335 Phone: Fax: 707-526-2022
Establishment
Registration: 3007038372
- Primary Contact: Dawn Norman, MS Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133, USA 618-604-3064 Phone: Fax: 707-526-2022
Company/Secondary Contact:
Kyle Lappin Sonoma Orthopedics Products, Inc 1388 Busch Parkway Buffalo Grove, IL 60089 Phone: 707-526-1335 Fax: 707-526-2022
- Trade Name: Sonoma Cancellous Bone Screw and Washer
- Common Name: Single/multiple component metallic bone fixation appliances and accessories Smooth or threaded metallic bone fixation fastener
Classification: Class II
- Regulation Number: 21 CFR 888.3030; 21 CFR 888.3040
Panel: 87- Orthopedic
Product Code(s): HWC, HTN
4
Predicate Device(s): K983495 Syntec Bone Screws
- Device Description: Sonoma Cancellous Bone Screws and Washers are a family of stainless steel screws and washers used for various skeletal repairs where cancellous screw thread profiles are clinically desired. The screws are offered in range of diameters from 4mm to 7.3mm, in both cannulated and solid configurations. The screw dimensions including thread profile, thread length, core diameter, cannulation diameter (where applicable), head diameter, overall length, and driving socket size are equivalent to the predicate device. Where applicable, these features are dimensioned as described by ASTM F543-13 (i.e. 4.0mm and 6.5mm solid screws). The washers are sized according to screw diameter and can be used to prevent head subsidence in soft bone. The screws and washers are manufactured from 316 stainless steel per ASTM F138.
- Indications for Use: The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the screw. The washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
- Substantial Equivalence: The intended uses of the subject device are the same as the predicate device. The materials of construction of the subject device are the same as the predicate device. The dimensions of the subject device are equivalent to the dimensions of the predicate device. The indications for use of both the subject and predicate devices are for the fixation of fractured bones. Thus, the subject device is substantially equivalent to the predicate device.
- Performance Testing: Engineering analysis and mechanical testing according to ASTM F543-13 in torsional properties and axial pullout testing demonstrate the subject device is substantially equivalent to the predicate device.