(67 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical external fixation system and explicitly states that AI, DNN, or ML were "Not Found" in the description.
Yes
The device is intended for the treatment of long bone and pelvic fractures, which aligns with the definition of a therapeutic device.
No
Explanation: The device description and intended use indicate that this product, Synthes Large External Fixation, is used for treatment and stabilization of fractures, not for diagnosing medical conditions.
No
The device description explicitly lists physical components like clamps, rods, Schanz screws, and Steinmann pins, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Synthes Large External Fixation: The description clearly states that this device is used for the treatment of bone and pelvic fractures. It is a physical device that is applied externally to the body to stabilize fractures. It does not involve the analysis of biological specimens.
The intended use and device description are consistent with a surgical device used for orthopedic procedures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Synthes Large External Fixation is intended for use to 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
- Polytrauma/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
Product codes
KTT
Device Description
The Synthes Large External Fixation, MR Conditional consists of previously cleared clamps, rods, Schanz screws and Steinmann pins. Synthes will also offer Sterile Packaged Large External Fixation Kits, MR Conditional. These kits contain previously cleared external fixation devices and manual surgical instruments.
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
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 External Fixation Devices
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.
0
Image /page/0/Picture/1 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. A horizontal line is located underneath the word "SYNTHES". The "®" symbol is located to the right of the word.
3.0 510(k) Summary
KOS 2650
Page _________________________________________________________________________________________________________________________________________________________________________
Sponsor: Synthes (USA) 1301 Goshen Parkway West Chester. PA 19380 (610) 719-5000
Jill R. Sherman
Contact:
Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6538 Fax: 484-356-9682
Synthes Large External Fixation, MR Conditional
Device Name:
Classification:
21 CFR Part 888.3030; Single/multiple component metallic bone fixation appliances and accessories.
Predicate Devices: Synthes External Fixation Devices
Device Description: The Synthes Large External Fixation, MR Conditional consists of previously cleared clamps, rods, Schanz screws and Steinmann pins. Synthes will also offer Sterile Packaged Large External Fixation Kits, MR Conditional. These kits contain previously cleared external fixation devices and manual surgical instruments.
Intended Use:
Synthes Large External Fixation is intended for use to 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
- Polytrauma/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 ioints
- 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
Information presented supports substantial equivalence.
Substantial Equivalence
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. 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
NOV 1 8 2008
Synthes (USA) % Ms. Jill R. Sherman 1301 Goshen Parkway West Chester, PA 19380
Re: K082650
Trade/Device Name: Synthes Large External Fixation, MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: KTT Dated: September 11, 2008 Received: September 12, 2008
Dear Ms. Sherman:
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.
2
Page 2 - Ms. Jill R. Sherman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes Large External Fixation, MR Conditional
Indications for Use:
Synthes Large External Fixation is intended for use to 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 -
- -Polytrauma/multiple orthopedic trauma
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable ー 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
AND/OR
Da
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Division Sign-Off) Page Division of General, Restorative, and Neurological Devices
510(k) Number K082650
of