(31 days)
Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe, Synthes Small Combination Clamp - MR Safe
Not Found
No
The device description focuses on mechanical components for external fixation and their MR compatibility, with no mention of AI or ML capabilities.
Yes
The device is an external fixation frame component intended to treat fractures and dislocations, which directly addresses a health condition.
No
The intent of the device is to treat fractures as a component of an external fixation frame, not to diagnose medical conditions.
No
The device description clearly states it is a component of an external fixation frame made from nonmagnetic materials, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Synthes Small Adjustable Clamps are components of an external fixation frame. This frame is used to physically stabilize and treat fractures and dislocations.
- Intended Use: The intended use describes the treatment of fractures and dislocations of specific anatomical sites. This is a therapeutic use, not a diagnostic one.
The device is a surgical implant/external fixation device, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Synthes Small Adjustable Clamps - MR Safe Line Extension are intended for fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; and failed closed reduction and casting resulting in secondary deformity of the distal radius.
Product codes
LXT
Device Description
Synthes Small Adjustable Clamps - MR Safe Line Extension are components of an external fixation frame that forms a construct intended to treat the hand, wrist, mandible and foot. They are all made from nonmagnetic materials and are intended to be used in an MR environment. An MR environment is described as the general environment present in the vicinity of an MR Scanner and/or anywhere in the procedure room, including the center of the bore of the MR Scanner. When used in a frame construct, the Small Adjustable Clamp-MR Safe accepts Synthes 4.0 mm carbon fiber rods and Synthes 4.0/4.0, 4.0/3.0 and 4.0/2.5 mm Schanz screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, mandible and foot
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe, Synthes Small Combination Clamp - MR Safe
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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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person. A small "R" in a circle is located to the upper right of the word "SYNTHES", indicating that it is a registered trademark.
Page __ 1 __ of __ 1 3.0 510(k) Summary Synthes (USA) Sponsor: 1302 Wrights Lane East West Chester, PA 19380 (610) 719-5000 Synthes (USA) Small Adjustable Clamp - MR Safe Line Extension Device Name: Class II, $888.3030 -- Single/multiple component bone fixation appliances Classification: and accessories Synthes 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe Predicate Device: Synthes Small Combination Clamp - MR Safe Synthes Small Adjustable Clamps - MR Safe Line Extension are Device Description: components of an external fixation frame that forms a construct intended to treat the hand, wrist, mandible and foot. They are all made from nonmagnetic materials and are intended to be used in an MR environment. An MR environment is described as the general environment present in the vicinity of an MR Scanner and/or anywhere in the procedure room, including the center of the bore of the MR Scanner. When used in a frame construct, the Small Adjustable Clamp-MR Safe accepts Synthes 4.0 mm carbon fiber rods and Synthes 4.0/4.0, 4.0/3.0 and 4.0/2.5 mm Schanz screws. Synthes Small Adjustable Clamps - MR Safe Line Extension are intended Intended Use: for fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement: and failed closed reduction and casting resulting in secondary deformity of the distal radius. Documentation is provided which demonstrates that the Synthes (USA) Substantial Equivalence: Small Adjustable Clamps- MR Safe Line Extension is substantially equivalent to other legally marketed devices.
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Image /page/1/Picture/1 description: The image is a black and white logo. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest the bird's head, body, and wings. The bird is facing to the right. Encircling the bird is text that reads, "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC.", arranged in a circular fashion around the bird.
APR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Sr. Regulatory Affairs Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania
Re: K050631
Trade/Device Name: Synthes (USA) Small Adjustable Clamp – MR Safe Line Extension Regulation Numbers: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: LXT Dated: March 10, 2005 Received: March 11, 2005
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 such 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); 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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Plurdes
Miriam Provost, Ph.D.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. There is a registered trademark symbol to the right of the word. A horizontal line runs beneath the entire logo.
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Indications for Use
510(k) Number (if known):
Synthes (USA) Small Adjustable Clamp - MR Safe Line Extension Device Name:
Indications for Use:
Synthes Small Adjustable Clamps - MR Safe Line Extension are intended for fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; and failed closed reduction and casting resulting in secondary deformity of the distal radius.
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)
Hught Charles
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________