(87 days)
Not Found
Not Found
No
The summary describes a metal plate for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is a metal plate used for fixation of fractures and osteotomies (bone cuts) of the distal tibia, which is a structural support and not a therapeutic treatment.
No
Explanation: The Synthes Pilon Plate is described as a metal plate intended for fixation of fractures and osteotomies. Its function is to provide structural support, not to diagnose a condition.
No
The device description explicitly states it is a "metal plate," which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures and osteotomies of the distal tibia. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a metal plate designed for surgical implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not perform any such function.
The Synthes Pilon Plate is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Synthes Pilon Plate is a metal plate that offers screw to plate locking designed for various fracture modes of the distal end of the tibia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal end of the tibia
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)
Documentation was provided which demonstrated the Synthes Pilon Plate to be substantially equivalent to other legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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3. Summary of Safety and Effectiveness Information
:
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull
(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes Pilon Plate |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes Pilon
Plate to be substantially equivalent to other legally marketed devices. |
| Device Description | The Synthes Pilon Plate is a metal plate that offers screw to plate
locking designed for various fracture modes of the distal end of the
tibia. |
| Indications | The Synthes Pilon Plate is intended for fixation of complex intra- and
extra-articular fractures and osteotomies of the distal tibia. |
| Materials | Stainless Steel or Titanium |
Synthes (USA) Synthes Pilon Plate 510(k) CONFIDENTIAL
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2002
Mr. Matthew M. Hull Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road PO Box 1766 Paoli, PA 19301
Re: K020602
Trade/Device Name: Synthes Pilon Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 19, 2002 Received: February 22, 2002
Dear Mr. Hull:
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. Matthew M. Hull
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and h your e FDA finding of substantial equivalence of your device to a legally premated predicated on "ceresults 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark A. Milhenser
Celia 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
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Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
C20602
Synthes Pilon Plate
The Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.
(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) OR
Over-The-Counter Use
la Mark N. Milkinson
(Division Sign-Off) Division of General, Restoreralve and Neurological Device
510(k) Number K020607
Synthes (USA) Synthes Pilon Plate 510(k) CONFIDENTIAL