(48 days)
Not Found
No
The device description and intended use are purely mechanical in nature, describing a bone plate for fracture fixation. There is no mention of software, algorithms, or any features that would suggest AI/ML is involved. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is a reconstruction plate used for the fixation of fractures, osteotomies, and non-unions, which is a structural support device rather than a device that directly treats or prevents a disease or condition therapeutically.
No
Explanation: The device is a surgical plate intended for fixation of fractures and non-unions, not for diagnosing medical conditions.
No
The device description clearly states it is a physical plate made of stainless steel or titanium, intended for surgical fixation of bones. It does not describe any software component.
Based on the provided information, the Synthes 4.5 mm LCP Straight Reconstruction Plates are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the Synthes 4.5 mm LCP Straight Reconstruction Plates clearly state they are used for the fixation of fractures, osteotomies, and non-unions within the body. They are implants used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes 4.5 mm LCP Straight Reconstruction Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Product codes
HRS
Device Description
Synthes 4.5 mm LCP Straight Reconstruction Plates consist of a limited contact profile and have LCP holes. The LCP hole is a combination of Dynamic Compression (DCU) and conical threaded locking holes, which accept cortex, shaft, cancellous, and locking screws. The plates are manufactured in either stainless steel or titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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 3.5 mm LCP Straight Reconstruction 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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads "K051986". The characters are written in black ink on a white background and have a slightly irregular, handwritten style.
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. There is a horizontal line underneath the word.
SEP - 8 2005
3.0 510(k) Summary
Page ________ of _____ of __1
| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
(610) 719-5000 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes 4.5 mm LCP Straight Reconstruction Plates |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone
fixation appliances and accessories |
| Predicate Devices: | Synthes 3.5 mm LCP Straight Reconstruction Plates |
| Device Description: | Synthes 4.5 mm LCP Straight Reconstruction Plates consist of a
limited contact profile and have LCP holes. The LCP hole is a
combination of Dynamic Compression (DCU) and conical
threaded locking holes, which accept cortex, shaft, cancellous, and
locking screws. The plates are manufactured in either stainless
steel or titanium. |
| Intended Use: | The Synthes 4.5 mm LCP Straight Reconstruction Plates are
intended for fixation of fractures, osteotomies and non-unions of
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal
tibia, fibula, particularly in osteopenic bone. |
| Substantial
Equivalence: | Information presented supports substantial equivalence. |
:
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circle around the eagle.
SEP - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Sr. Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051986
Trade/Device Name: Synthes (USA) 4.5 mm LCP Straight Reconstruction 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: July 21, 2005 Received: July 22, 2005
Dear Ms. Musgnung:
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. Sheri L. Musgnung
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/dsma/dsmamain.html
Sincerely yours,
Neil R.P. Dykstra
Mark N. Mollen
Mark N. Melkerson 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 circular logo with a design inside. A horizontal line is underneath the word "SYNTHES" and the logo.
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) 4.5 mm LCP Straight Reconstruction Plates
INDICATIONS FOR USE:
The Synthes 4.5 mm LCP Straight Reconstruction Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
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)
Nil R. Ogden for mxm
Ci. Ross
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K051986
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