(62 days)
Not Found
Not Found
No
The summary describes a bone fixation plate, a purely mechanical device, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is a bone fixation plate used for internal fixation of fractures, which is a structural support device rather than one that delivers therapy (e.g., drug, radiation, electrical stimulation).
No
This device is a bone fixation plate used for internal fixation of tibia fractures, which is a treatment device, not a diagnostic one.
No
The device description clearly states it is a bone fixation plate, which is a physical hardware component, not software.
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, or tissue) to provide information about a person's health.
- Device Description: The Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are implants used for internal fixation of bone fractures. They are surgically placed within the body to stabilize broken bones.
- Intended Use: The intended use is for the internal fixation of bone fractures, not for testing or analyzing biological specimens.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
Product codes
HRS
Device Description
The Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are pre-contoured bone fixation plates intended for the treatment of fractures of the tibia. The plates are offered sterile and non-sterile and are available in stainless steel and titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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) 3.5mm / 4.5mm LCP Metaphyseal Plates, Synthes (USA) Large Fragment LCP System T Plates
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
KOS2624
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. A registered trademark symbol is to the right of the word.
3.0
NOV 1 0 2008 510(k) Summary Page __ 1 __ of 1 Synthes (USA) Sponsor: Karl J. Nittinger 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6941 Device Name: Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates Class II, §888.3030 - Single / multiple component metallic bone Classification: fixation appliance and accessories. Predicate Device: Synthes (USA) 3.5mm / 4.5mm LCP Metaphyseal Plates Synthes (USA) Large Fragment LCP System T Plates Device Description: The Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are pre-contoured bone fixation plates intended for the treatment of fractures of the tibia. The plates are offered sterile and non-sterile and are available in stainless steel and titanium. Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are Intended Use: indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia. Substantial Information presented supports substantial equivalence. Equivalence:
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three legs, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Mr. Karl J. Nittinger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
NOV 1 0 2008
Re: K082624
Trade/Device Name: Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS Dated: September 8, 2008 Received: September 9, 2008
Dear Mr. Nittinger:
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 - Mr. Karl J. Nittinger
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 N Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SYNTHES®
p. 1/1
Indications for Use
510(k) Number (if known):
Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates Device Name:
Indications for Use:
Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
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)
Mark H. Milliken
(Division Sign-Off) (Division Sign-Ona), Restorative, Division of Neurological Devices
510(k) Number
2.0