(111 days)
Synthes 6.5 mm Cannulated Screws
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No
The device description and intended use are for a mechanical orthopedic screw and associated hardware, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is a medical screw intended for fracture fixation and arthrodeses, which are surgical procedures, not therapeutic treatments in the typical sense of providing therapy for a disease or condition. While it aids in healing and stability, it is a mechanical implant rather than a therapeutic device.
No
The device is described as a screw intended for fracture fixation of bones, which is a treatment, not a diagnostic, function.
No
The device description clearly states it is a physical screw made of stainless steel, intended for surgical implantation. It is a hardware device, not software.
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, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws are implants used for fracture fixation of bones. They are physically inserted into the body.
- Intended Use: The intended use is for surgical procedures to stabilize bone fractures and conditions, not for analyzing biological samples.
Therefore, based on the description and intended use, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws are intended for fracture fixation of large bones and large bone fragments including femoral neck fractures; slimbed capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.
Product codes
HWC
Device Description
The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws (SCFE) have a cannulated shaft, are self-tapping with a cancellous thread that can be guided into position via a 2.8 mm guide wire, and range in overall lengths from 45 mm - 130 mm, and have 10 mm and 20 mm thread lengths. Oval washers of 1 mm and 2 mm are also available to use with the screws for precise depth placement in bone. The screws and washers are available in stainless steel.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
large bones and large bone fragments including femoral neck, tibial plateau, ankle, SI joint, subtalar
Indicated Patient Age Range
pediatric (specifically for femoral neck fractures)
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Synthes 6.5 mm Cannulated Screws
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. The word "SYNTHES" appears to be a company or brand name. The logo and text are the main focus of the image.
3.0
510(k) Summary Page __ 1 __ of __ 1 Sponsor: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 JAN 1 1 2010 (610) 719-6940 . Contact: Sheri L. Musgnung Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 (610):119-6940 FAX (484) 356-9682 Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Device Name: Screws (SCFE) Classification: Class II, $888.3040 -- Smooth or threaded metallic bone fixation fastener Predicate Device: Synthes 6.5 mm Cannulated Screws Synthes Washers Device Description: The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws (SCFE) have a cannulated shaft, are self-tapping with a cancellous thread that can be guided into position via a 2.8 mm guide wire, and range in overall lengths from 45 mm - 130 mm, and have 10 mm and 20 mm thread lengths. Oval washers of 1 mm and 2 mm are also available to use with the screws for precise depth placement in bone. The screws and washers are available in stainless steel. Intended Use: The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws are intended for fracture fixation of large bones and large bone fragments including femoral neck fractures; slimbed capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses. Substantial Information presented supports substantial equivalence. Equivalence:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling the perimeter in a circular arrangement. In the center is a stylized emblem, possibly representing human services or well-being. The emblem is composed of three curved shapes that resemble a stylized bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Synthes USA, Inc. % Ms. Sheri L. Musgnung 1301 Goshen Parkway West Chester, Pennsylvania 19380
JAN 1 1 2010
Re: K092909
Trade/Device Name: Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis . Screws (SCFE) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 23, 2009 Received: December 24, 2009
Dear Ms. Musgnung:
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.
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 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.
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Page 2- Ms. Sheri L. Musgnung
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Barbara Green
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws (SCFE)
Indications for Use:
The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws are intended for fracture fixation of large bones and large bone fragments including femoral necla fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sauter for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092909