(79 days)
Not Found
No
The 510(k) summary describes a mechanical external fixator and makes no mention of AI or ML technology.
Yes
The device is described as stabilizing fractures of the distal radius, which is a therapeutic function.
No.
The device is described as a "Wrist Fixator" used for stabilization and treatment of fractures, not for identifying or classifying conditions.
No
The device description clearly outlines physical hardware components (frame elements, pins, clamps, carbon fiber rod, end caps) that form the medical device. It is not solely 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 Synthes Low-Profile Wrist Fixator is a physical device that is surgically implanted or applied externally to stabilize a bone fracture. It does not perform any tests on bodily samples.
- Intended Use: The intended use is "stabilization of fractures of the distal radius," which is a mechanical function, not a diagnostic one.
This device is a surgical implant/external fixation device, not an IVD.
N/A
Intended Use / Indications for Use
The Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
Product codes
KTT
Device Description
The Synthes Low-Profile Wrist Fixator consists of frame elements that form a construct intended to treat fractures of the distal radius. The Low-Profile Wrist Fixator provides stabilization of fractures via pins (Schanz screws) inserted proximally and distally to a fracture and connected by an external bridging frame consisting of two Low-Profile Wrist Fixator Clamps - MR Safe, a carbon fiber rod and two protective end caps. The Low-Profile Wrist Fixator is available as a complete sterile assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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)
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 circular logo with a stylized image inside. A horizontal line runs beneath the word, and a registered trademark symbol is to the right of the word.
Image /page/0/Picture/2 description: The image shows the text 'KOS1049' in a handwritten style. The letters and numbers are bold and slightly uneven, suggesting they were written quickly or with a thick marker. The text is the primary focus of the image, with no other discernible background elements.
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3.0 510(k) Summary
Page ________ of _____________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
(610) 719-5860 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Low-Profile Wrist Fixator |
| Classification: | Class II, §888.3030 - Single/multiple component bone fixation
appliances and accessories |
| Predicate Devices: | Orthofix Penning Wrist Fixator
Synthes (USA) Articulating Distal Radius System
Synthes (USA) 4.0 mm Adjustable Clamp for Distal Radius |
| Device Description: | The Synthes Low-Profile Wrist Fixator consists of frame elements
that form a construct intended to treat fractures of the distal radius.
The Low-Profile Wrist Fixator provides stabilization of fractures
via pins (Schanz screws) inserted proximally and distally to a
fracture and connected by an external bridging frame consisting of
two Low-Profile Wrist Fixator Clamps - MR Safe, a carbon fiber
rod and two protective end caps. The Low-Profile Wrist Fixator is
available as a complete sterile assembly. |
| Intended Use: | The Synthes Low-Profile Wrist Fixator is intended for stabilization
of fractures of the distal radius. |
| Substantial
Equivalence: | Documentation is provided which demonstrates that the Synthes
(USA) Low-Profile Wrist Fixator is substantially equivalent to
other legally marketed devices.
The term "substantial equivalence" as used in this 510(k)
notification is limited to the definition of substantial equivalence
found in the Federal Food, Drug and Cosmetic Act, as amended
and as applied under 21CFR 807, Subpart E under which a device
can be marketed without premarket approval or reclassification. A
determination of substantial equivalency under this notification is
not intended to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent matters. No
statements related to, or in support of substantial equivalence
herein shall be construed as an admission against interest under the
US Patent Laws or their application by the courts. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2005
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051049
K031047
Trade/Device Name: Synthes (USA) Low-Profile Wrist Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 21, 2005 Received: June 22, 2005
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainted institution was and starting and in interests a ferenced above and nave determined the arrested predicate devices marketed in interstate for use stated in the encrosule) to regally manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prof to May 26, 1976, the encordance with the provisions of the Federal Food. Drug, devices that have been recure approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act . The and Cosment Act (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the device, basjoct to the go
general controls provisions of the Act include requirements for annual registration, listing of the general controls provisions of the free 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 II your device is classified (soc aboro) ins Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and considerer may be subject to such additional controllar Extrong may on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, be found in the Code of I same concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA S Issualled of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a dolorimiations administered by other Federal agencies. You must of any Federal statutes and regulations anning, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercially, and manufacturing practice requirements as set and CFK Part 807), labeling (21 CFR Part 807), good and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Kathy Anderson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailiering of substantial equivalence of your device to a legally premarket notincation: "The Privating of cation 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 If you desire specific acritor 101-12-1120. Also, please note the regulation entitled, Colliact the Office of Compunation in (21CFR Part 807.97). You may obtain Misblanding by reference to promantsvillities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octoss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mirian 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 word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized image of a person. A registered trademark symbol is located to the right of the word. A horizontal line is located underneath the word.
Page 1 of 1
2.0 Indications for Use
| 510(k) Number (if known): | K051049 |
|---|---|
| --------------------------- | --------- |
Device Name: Synthes (USA) Low-Profile Wrist Fixator
Indications for Use:
The Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
X Prescription Use (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)
- 4 -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Purda
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________ KOSTOYG