(75 days)
Synthes Stainless Steel Modular Hand System, Synthes Modular Foot System, Synthes Modular Foot System - 2.7 mm Module
Not Found
No
The device description and intended use are purely mechanical in nature, describing plates and screws for bone fixation. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
Yes
The device is described as an implant system for fixation of bone fractures and fusions, which directly treats anatomical injuries.
No
Explanation: The device is described as a system for fixation of fractures and similar bone issues, which is a treatment or surgical intervention, not a diagnostic process.
No
The device description explicitly details physical implants (plates and screws) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a system of plates and screws used to attach to bone. These are physical implants used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is a surgical implant used for orthopedic procedures, not for testing biological samples.
N/A
Intended Use / Indications for Use
The Synthes (USA) Modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Product codes
HRS
Device Description
The Synthes (USA) Modular Mini Fragment LCP System includes 2.0, 2.4, and 2.7 mm size implants. The system incorporates a series of locking compression plates and screws of varying lengths, thicknesses, and configurations including straight, condylar, T-, Y-, adaption plates. These plates are attached to bone via 2.0, 2.4, and 2.7 mm cortex and locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
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 Stainless Steel Modular Hand System, Synthes Modular Foot System, Synthes Modular Foot System - 2.7 mm Module
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 the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line below the word "SYNTHES". A small circled "R" is to the right of the word.
510(k) Summary
:
3.0
:
DEC 1 8 2006
Page _________ of ____________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-5000 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Modular Mini Fragment LCP System |
| Classification: | 21 CFR 888.3030: Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3040: Smooth or threaded metallic bone fixation
fastener |
| Predicate Devices: | Synthes Stainless Steel Modular Hand System
Synthes Modular Foot System
Synthes Modular Foot System - 2.7 mm Module |
| Device Description: | The Synthes (USA) Modular Mini Fragment LCP System includes
2.0, 2.4, and 2.7 mm size implants. The system incorporates a
series of locking compression plates and screws of varying lengths,
thicknesses, and configurations including straight, condylar, T-, Y-,
adaption plates. These plates are attached to bone via 2.0, 2.4, and
2.7 mm cortex and locking screws. |
| Intended Use: | The Synthes (USA) Modular Mini Fragment LCP System is
intended for fixation of fractures, osteotomies, nonunions,
replantations, and fusions of small bones and small bone
fragments, particularly in osteopenic bone. Examples include, but
are not limited to, the hand, wrist, foot, and ankle. |
| Substantial
Equivalence: | Information presented supports substantial equivalence. |
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:
1
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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2006
Synthes (USA) % Deborah L. Jackson, RAC Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K063049
Trade/Device Name: Synthes (USA) Modular Mini Fragment LCP System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: October 3. 2006 Received: October 6, 2006
Dear Dr. Clark
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 - Deborah L. Jackson, RAC
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) 276-0210 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/industry/support/index.html.
Sincerely vours.
For Pete O
Mark N. Melkerson
Rum̃o
osp
D.K
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. There is a horizontal line underneath the word.
Page 1 of
2.0 Indications for Use
510(k) Number (if known):
Device Name: Synthes (USA) Modular Mini Fragment LCP System Indications for Use: The Synthes (USA) Modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
X Prescription Use --(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)
Ohl
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L063049