(60 days)
The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft, 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm locking screws along with 2.4 mm and 2.7 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths.
This document is a 510(k) Summary for a medical device called "Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications." It's for an orthopedic implant, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance are not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting that their modified device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
Here's the information extracted from the provided text that is relevant to the type of device:
Device Information:
- Device Name: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications
- Classification: Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories
- Predicate Device: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes One Third Tubular LCP Plate
- Intended Use/Indications for Use: The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
- Material: Available in stainless steel and titanium.
Substantial Equivalence:
The document states that "Information presented supports substantial equivalence" to the predicate devices. This is the primary "acceptance criterion" for a 510(k) submission of this type. The specifics of how this equivalence was demonstrated (e.g., mechanical testing, material comparisons, design comparisons) are not detailed in this summary document but would have been part of the full 510(k) submission.
Regarding the specific questions about acceptance criteria and studies for an AI/ML device:
As this is a mechanical orthopedic implant, the following questions are not applicable:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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DEC 3 0 2008
K083213
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 | |
| Contact: | Sheri L. MusgnungSynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6940 | |
| Device Name: | Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications | |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories | |
| Predicate Device: | Synthes 2.7 mm/3.5 mm LCP Distal Fibula PlatesSynthes One Third Tubular LCP Plate | |
| Device Description: | Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured tomatch the anatomy of the distal fibula and diaphyseal region. Theplates feature a low-profile design and Combi holes (DynamicCompression Plate holes combined with locking screw holes),which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mmshaft, 3.5 mm locking screws, and 4.0 mm cancellous screws. Theplates locking holes accept 2.4 mm, 2.7 mm locking screws alongwith 2.4 mm and 2.7 mm self-tapping cortex screws. The platesare available in stainless steel and titanium, as well as a variety oflengths. | |
| Intended Use: | The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates areindicated for fractures, osteotomies, and non-unions of themetaphyseal and diaphyseal region of the distal fibula, especiallyin osteopenic bone. | |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri L. Musgnung 1301 Goshen Parkway West Chester, PA 19380
DEC 3 0 2008
Re: K083213
Trade/Device Name: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates 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: October 30, 2008 Reccived: October 31, 2008
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.
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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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark Y. Millman
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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2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates
Indications for Use:
The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
Prescription Use (Per 21 CFR 801.109)
ﺎﻳﺔ
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)
Daird Krone for mscu
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K063213
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§ 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.