(23 days)
Synthes 3.5mm Titanium LCPTM Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The Synthes 3.5mm Titanium LCPTM Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. The plates are designed for either the right or left tibia and are available in a variety of lengths. The plates are available in a variety of lengths.
The proximal portion of the plate head accepts 3.5mm titanium locking screws, the distal portion of the plate accepts 3.5 mm titanium locking screws, 3.5 mm titanium cortex screws, or 4.0 mm titanium cancellous bone screws.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. It is a 510(k) summary for the Synthes 3.5mm Titanium LCP™ Proximal Tibia Plate, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical or technical study against predefined acceptance criteria.
Therefore, I am unable to provide the requested information in the specified format from the given text.
The document primarily covers:
- Sponsor and contact information
- Device name and classification
- Predicate device
- Device description
- Indications for Use
- Material
It also includes the FDA's letter confirming substantial equivalence to the predicate, which is a regulatory finding that allows the device to be marketed, but does not detail specific performance-based acceptance criteria or a study proving those criteria were met.
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030597
page 1 of 1
ryl
MAR 2 0 2003
Summary of Safety and Effectiveness Information [510(k) Summary] 3.
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Lisa M. Boyle(610) 647-9700 ext. 7593 |
| Name of the Device | Synthes 3.5mm Titanium LCPTM Proximal Tibia Plate |
| Device Classification | Class II, §888.3030 - Plate, Fixation, Bone, Non-spinal, Metallic |
| Predicate Device | Synthes 3.5mm SS LCP Proximal™ Tibia PlateSynthes Large Fragment LCP T- Plate |
| Device Description | The Synthes 3.5mm Titanium LCPTM Proximal Tibia Plates arecontoured to match the anatomy of the proximal tibia with a limitedcontact low profile design. The plates are designed for either the rightor left tibia and are available in a variety of lengths. The plates areavailable in a variety of lengths.The proximal portion of the plate head accepts 3.5mm titaniumlocking screws, the distal portion of the plate accepts 3.5 mm titaniumlocking screws, 3.5 mm titanium cortex screws, or 4.0 mm titaniumcancellous bone screws. |
| Indications | Synthes 3.5mm Titanium LCPTM Proximal Tibia Plate is intendedtreatment of non-unions, malunions, and fractures of the proximaltibia, including simple, comminuted, lateral wedge, depression, medialwedge, bicondylar, combinations of lateral wedge and depression, andfractures with associated shaft fractures. |
| Materials | Titanium |
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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 features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Ms. Lisa M. Boyle Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K030597
Trade/Device Name: Synthes 3.5mm Titanium LCP™ Proximal Tibia Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: February 21, 2003 Received: February 25, 2003
Dear Ms. Boyle:
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
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Page 2 - Ms. Lisa M. Boyle
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 Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes 3.5mm Titanium LCP™ Proximal Tibia Plate
Synthes Titanium LCP Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
(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
for Mark n Melkern
(Division Sign-Off)
Division of Comerel Destorative
ances
Over-The-Counter Use_
Synthes(USA)
CONFIDENTIALDER
Synthes Titanium LCP™ Proximal Tibia Plates 510(k)
K030597
0004
0004
§ 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.