(91 days)
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Not Found
No
The summary describes a mechanical orthopedic plate and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is a plate intended to augment the stabilization of fractures in bones. While it assists in the healing process, it doesn't directly provide therapy in the sense of actively treating or curing a disease or condition. Its primary function is mechanical support.
No
Explanation: This device is a surgical implant (plate) used to stabilize fractures, not to diagnose medical conditions.
No
The device description explicitly states the device is a "low-profile, pre-contoured plate" made of "stainless steel and titanium," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to stabilize bone fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description of the plates as low-profile, pre-contoured plates used with existing LCP plates further confirms its role as a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Synthes 3.5mm Locking Attachment Plate is intended for use with Synthes LCP plates to augment the stabilization of fractures including periprosthetic fractures, and fractures in the presence of intramedullary implants in the femur, tibia and humerus, particularly in osteopenic bone.
Product codes
HRS
Device Description
The Synthes 3.5mm Locking Attachment Plates are low-profile, pre-contoured plates which are intended to be used with existing Synthes LCP plates to stabilize fractures. The plates are available in stainless steel and titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
femur, tibia and humerus
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
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Summary of Performance Studies
Not Found
Key Metrics
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Predicate Device(s)
Synthes 1.7mm Cerclage Cable with Crimp, Synthes Universal Locking Trochanter Stabilization Plate
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/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A horizontal line runs beneath the word "SYNTHES" and the logo. A registered trademark symbol is located to the right of the word.
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3.0 510(k) Summary
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:
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
Karl J. Nittinger
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6941 | MAR - 4 2009 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name: | Synthes (USA) 3.5mm Locking Attachment Plates | |
| Classification: | Class II, §888.3030 - Single / multiple component metallic bone
fixation appliance and accessories. | |
| Predicate Device: | Synthes 1.7mm Cerclage Cable with Crimp
Synthes Universal Locking Trochanter Stabilization Plate | |
| Device Description: | The Synthes 3.5mm Locking Attachment Plates are low-profile,
pre-contoured plates which are intended to be used with existing
Synthes LCP plates to stabilize fractures. The plates are available in
stainless steel and titanium. | |
| Intended Use: | Synthes 3.5mm Locking Attachment Plate is intended for use with
Synthes LCP plates to augment the stabilization of fractures,
including periprosthetic fractures and fractures in the presence of
intramedullary implants, in the femur, tibia and humerus,
particularly in osteopenic bone. | |
| Substantial
Equivalence: | Information presented supports substantial equivalence. | |
、
: .
・
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 2009
Synthes (USA) % Mr. Karl J. Nittinger Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K083573
Trade/Device Name: Synthes (USA) 3.5mm Locking Attachment 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: December 1, 2008 Received: December 4, 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. Iisting 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
2
Page 2 - Mr. Karl J. Nittinger
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.
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
f. Ain. m.D. fos
Mark N. Melkerson 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. To the right of the word is a small circle with an R inside, indicating a registered trademark. The word and logo are likely part of a brand name or company logo.
2.0
:
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) 3.5mm Locking Attachment Plates
Indications for Use: .
Synthes 3.5mm Locking Attachment Plate is intended for use with Synthes LCP plates to augment the stabilization of fractures including periprosthetic fractures, and fractures in the presence of intramedullary implants in the femur, tibia and humerus, 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)
Ar. Ai, m.D. for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number