(75 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is described as an external fixation device used for treating various fracture types, including stabilization of soft tissues and fractures, treatment of polytrauma, and non-unions, which falls under therapeutic intervention.
No
Explanation: The device description states its purpose is to "form a construct intended to treat stable and unstable fractures" and is used for "construction of an external fixation frame." This indicates a therapeutic or treatment-oriented function, not a diagnostic one.
No
The device description clearly states it is a "system of components that form a construct" and mentions "frame elements," "Pin Clamps," and "Curved Carbon Fiber Rods," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The provided description clearly states that this device is an "External Fixation Device" used to construct a frame for treating bone fractures. It is a physical device applied externally to the body to stabilize bones.
- Intended Use: The intended use is for treating fractures and related orthopedic conditions, not for analyzing biological samples.
The description focuses on the mechanical function and application of the device for orthopedic treatment, which is completely different from the purpose of an IVD.
N/A
Intended Use / Indications for Use
Synthes External Fixation Devices - MR Safe are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- Stabilization of soft tissues and fractures .
- Poyltrauma/multiple orthopedic trauma .
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic . fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints .
- Neutralization of fractures stabilized with limited internal fixation .
- Non-unions/septic non-unions .
- Intra-operative reductions/stabilization tool to assist with indirect reduction .
- Unilateral rectilinear bone segment transport or leg lengthening .
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
Synthes External Fixation Systems, MR Safe are a system of components that form a construct intended to treat stable and unstable fractures. All frame elements are made from non-magnetic materials and are intended for use in the MR environment. This line extension consists of Synthes Pin Clamps with Outrigger Posts and additional Curved Carbon Fiber Rods. These components are also intended for use in the MR environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone and pelvic fractures
Indicated Patient Age Range
Pediatric and adult fractures
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): 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.
Synthes Reprocessed External Fixation Devices, Hoffmann II External Fixation System (Stryker), EBI XFIX Vision Fixation System
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
§ 888.3030 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.
0
11043039
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. A horizontal line is present below the word, adding a sense of grounding to the overall composition. The registered trademark symbol is located to the right of the word.
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1690 Russell Road | ||
| Paoli, PA 19301 | ||
| (610) 647-9700 | ||
| Device Name: | Synthes (USA) External Fixation Component Line Extension - MR Safe | |
| Classification: | Class II, §888.3030 - Single/multiple component bone fixation | |
| appliances and accessories | ||
| Predicate Device: | Synthes Reprocessed External Fixation Devices | |
| Hoffmann II External Fixation System (Stryker) | ||
| EBI XFIX Vision Fixation System | ||
| Device Description: | Synthes External Fixation Systems, MR Safe are a system of | |
| components that form a construct intended to treat stable and | ||
| unstable fractures. All frame elements are made from non- | ||
| magnetic materials and are intended for use in the MR | ||
| environment. This line extension consists of Synthes Pin Clamps | ||
| with Outrigger Posts and additional Curved Carbon Fiber Rods. | ||
| These components are also intended for use in the MR | ||
| environment. | ||
| Intended Use: | Synthes External Fixation Devices - MR Safe are intended for use | |
| in the construction of an external fixation frame for treatment of | ||
| various fracture types that require external fixation | ||
| Substantial | ||
| Equivalence: | Documentation is provided which demonstrates that the Synthes | |
| (USA) External Fixation Component Line Extension - MR Safe 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
Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
JAN 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy Anderson Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K043039
Trade/Device Name: Synthes (USA) External Fixation Component Line Extension – MR Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 2, 2004 Received: November 4, 2004
Dear Ms. Anderson:
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 for ass batted in the 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 r ou may) ators, orovisions of the Act include requirements for annual registration, listing of general volurols proving 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 or any I vathar sthates 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.
2
Page 2 - Ms. Kathy Anderson
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.
O. Mark A. Mullerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/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. There is a line underneath the word "SYNTHES". The registered trademark symbol is to the right of the word.
Mark N. Mlbess
and Neurological Devices
Indications for Use
2.0
510(k) Number K043039
510(k) Number (if known):
Synthes (USA) External Fixation Component Line Extension - MR Safe Device Name:
Indications for Use:
Synthes External Fixation Devices - MR Safe are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE
Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- Stabilization of soft tissues and fractures .
- Poyltrauma/multiple orthopedic trauma .
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic . fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints .
- Neutralization of fractures stabilized with limited internal fixation .
- Non-unions/septic non-unions .
- Intra-operative reductions/stabilization tool to assist with indirect reduction .
- Unilateral rectilinear bone segment transport or leg lengthening .
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)