(45 days)
Not Found
Not Found
No
The summary describes a mechanical implant (plates and screws) and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is a metallic implant used for internal fixation of small bone fractures, which is a structural support device rather than a therapeutic device that delivers treatment or therapy.
No
Explanation: The device is a plate and screw system for treating fractures, which is a therapeutic function, not a diagnostic one. It does not provide information about the presence, absence, or state of a disease or condition.
No
The device description clearly states it consists of physical plates and screws, which are hardware components.
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.
- Device Description: The Synthes LCP Modular Foot Plates are described as implants used to treat bone fractures and other orthopedic conditions. They are physically implanted into the body.
- Intended Use: The intended use is for surgical procedures on bones, not for analyzing biological samples.
The information provided clearly indicates this is a surgical implant, not a device used for laboratory testing of biological specimens.
N/A
Intended Use / Indications for Use
The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle.
Product codes
HRS
Device Description
Synthes LCP Modular Foot Plates consist of locking cuboid, navicular and talus plates used to treat small bone fractures. The plates are attached to bone via 2.4 and 2.7 mm cortex and locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Synthes (USA) Modular Foot System
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/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 letter "S" inside of a circle. To the right of the word is a registered trademark symbol. A horizontal line is located underneath 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) LCP Modular Foot Plates | |
| Classification: | Class II, §888.3030 – Single/multiple component bone fixation | |
| appliances and accessories | ||
| Predicate Device: | Synthes (USA) Modular Foot System | |
| Device Description: | Synthes LCP Modular Foot Plates consist of locking cuboid, | |
| navicular and talus plates used to treat small bone fractures. The | ||
| plates are attached to bone via 2.4 and 2.7 mm cortex and locking | ||
| screws. | ||
| Intended Use: | The Synthes LCP Modular Foot Plates are intended for use in | |
| selective trauma, fractures, osteotomies, reconstructive procedures | ||
| and replantations of small bones including the foot and ankle. | ||
| Substantial | ||
| Equivalence: | Documentation is provided which demonstrates that the Synthes | |
| (USA) LCP Modular Foot Plates are 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 & Human Services. The logo features a stylized graphic of an abstract human figure, represented by three curved lines, which is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.
Public Health Service
MAR 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kathy Anderson Regulatory Affairs Manager Synthes USA 1690 Russell Road Paoli, Pennsylvania 19301
Re: K050110 Trade/Device Name: LCP Modular Foot Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 17, 2005 Received: January 18, 2005
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o neve revea your your 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 connect 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 your be subject to such additional controls. Existing major regulations affecting your device r may or below 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 complics 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. 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 maneting your intial equivalence of your device to a legally prematics notification. "The PDF intently on 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 advise 10. 90. at 200) 276-0120 . Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorinational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark McMillan
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. A horizontal line is underneath the word "SYNTHES".
Page 1 of I
2.0
Indications for Use
510(k) Number (if known):
Synthes (USA) LCP Modular Foot Plates Device Name:
Indications for Use:
The Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, The Symnes ECF Modular Foot Rais and replantations of small bones including the foot and ankle.
Over-The-Counter Use AND/OR X Prescription Use _ (21 CFR 807 Subpart C) (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Gener Restorative,
and Neurological
510(k) K05 0110
CONFIDENTIAL .