(61 days)
Not Found
No
The document describes a mechanical bone plate system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a metallic plate system designed for fracture fixation, osteotomies, and non-unions, which are structural repairs rather than treatments aimed at restoring health from an illness or disease.
No
The device is a system of plates used for fracture fixation, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical plates and screws, which are hardware components, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes the Synthes 3.5 mm and 4.5 mm LCP Systems as implants used for the fixation of fractures, osteotomies, and non-unions of bones. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Synthes 3.5 mm Locking Compression Plate (LCP) System:
The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
Synthes 4.5 mm Locking Compression Plate (LCP) System:
The Synthes 4.5 mm Locking Compression Plate (LCP) System is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
Product codes
HRS, HWC
Device Description
Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist of 3.5 mm LCP plates, 4.5 mm Narrow LCP Plates, 4.5 mm Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex and cancellous screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, femur, diaphyseal and metaphyseal areas of long bones
Indicated Patient Age Range
adult patients, pediatric patients
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)
K033669, K993106, K000682, K000684, K041911
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 13 2009
Synthes (USA) % Ms. Jill R. Sherman 1301 Goshen Parkway West Chester, PA 19380
Re: K082807 Trade/Device Name: Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: September 23, 2008 Received: September 24, 2008
Dear Ms. Sherman:
This letter corrects our substantially equivalent letter of November 24, 2008.
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 (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 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
1
Page 2 - Ms. Jill R. Sherman
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Milken
Mark N Milken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 2.0 | Indications for Use |
|---|---|
| 510(k) Number (if known): | K082807 |
| Device Name: | Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate |
| (LCP) System with Expanded Indications |
Indications for Use:
Synthes 3.5 mm Locking Compression Plate (LCP) System:
The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
Synthes 4.5 mm Locking Compression Plate (LCP) System:
The Synthes 4.5 mm Locking Compression Plate (LCP) System is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
and the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states o
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801.109) | X | |
|---|---|---|
| AND/OR | Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
| Division Sign-Off) | Page 1 of 1 |
|---|---|
| General Restorative, | |
| Neurological Devices | |
| 510(k) Number | K082807 |
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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 located underneath the word.
3.0 510(k) Summary
Page _________ of __1
.
.
,
| Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-5000 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jill R. Sherman
Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
Phone: 610-719-6538 Fax: 484-356-9682 |
| Device Name: | Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP)
System with Expanded Indications |
| Classification: | 21 CFR Part 888.3030; Single/multiple component metallic bone
fixation appliances and accessories. |
| Predicate Devices: | Smith & Nephew Locking Bone Plate System (K033669)
Smith & Nephew Bone Plate System (K993106)
Synthes Locking Compression Plates (K000682, K000684, K041911) |
| Device Description: | Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications
consist of 3.5 mm LCP plates, 4.5 mm Narrow LCP Plates, 4.5 mm
Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture
fixation in adults and pediatric patients. These plates accept locking,
cortex and cancellous screws. |
| Intended Use: | Synthes 3.5 mm Locking Compression Plate (LCP) System:
The Synthes 3.5 mm LCP is indicated for fixation of fractures,
osteotomies and non-unions of the clavicle, scapula, olectranon,
humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in
osteopenic bone for adult patients. |
| | These plates are also indicated for fracture fixation of diaphyseal
and metaphyseal areas of long bones in pediatric patients. |
| | Synthes 4.5 mm Locking Compression Plate (LCP) System:
The Synthes 4.5 mm LCP is indicated for fixation of various long
bones, such as the humerus, femur and tibia and for use in fixation
of peri-prosthetic fractures, osteopenic bone and fixation of non-
unions or malunions in adult patients. |
| | These plates are also indicated for fracture fixation of diaphyseal
and metaphyseal areas of long bones in pediatric patients. |
| Substantial
Equivalence | Information presented supports substantial equivalence. |
.