(88 days)
Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
Synthes Medial Distal Tibia Plates are available in two sizes: 3.5 mm and 4.5 mm. They are pre-contoured to fit the distal tibia anatomy. The plates feature a limited contact - dynamic compression plate (LC-DCP) design and are available in right and left versions. The end of the plate includes a hole for a suture, if necessary. The plates accept 3.5 mm, 4.0 mm, 4.5 mm cortex screws, and 4.0 mm cancellous screws.
The provided text is a 510(k) summary for the Synthes Medial Distal Tibia Plates, which is a medical device. This document does not describe the acceptance criteria or a study proving the device meets those criteria.
Instead, this document focuses on:
- Device identification: Name, common name, classification, and predicate device.
- Device description: Physical characteristics and materials.
- Intended use/indications for use: What the device is designed to treat.
- Regulatory approval: Confirmation from the FDA that the device is substantially equivalent to a legally marketed predicate device.
To answer your specific questions about acceptance criteria and study details, a different type of document, such as a clinical study report, validation report, or specific performance testing report, would be needed. The 510(k) summary is primarily for regulatory clearance based on substantial equivalence, not detailed performance metrics and acceptance criteria from a specific study.
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SEP 22 2000
Attachment VII:
Summary of Safety and Effectiveness Information [510(k) Summary]
SUBMITTER
Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700
Contact: Angela Silvestri
DEVICE NAME:
COMMON OR USUAL NAME
DEVICE CLASSIFICATION:
PREDICATE DEVICE:
DESCRIPTION:
INTENDED USE:
MATERIAL:
Paoli, PA 19301
(610) 647-9700
Contact: Angela Silvestri
Synthes Medial Distal Tibia Plates
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Screw, Fixation, Bone
Class II, 21 CFR 888.3030 and 888.3040
Synthes Small T-Plate (pre-76) Synthes One-Third Tubular Plate (pre-76) Synthes 3.5 mm Cortex Screw (pre-76)
Synthes Medial Distal Tibia Plates are available in two sizes: 3.5 mm and 4.5 mm. They are pre-contoured to fit the distal tibia anatomy. The plates feature a limited contact - dynamic compression plate (LC-DCP) design and are available in right and left versions. The end of the plate includes a hole for a suture, if necessary. The plates accept 3.5 mm, 4.0 mm, 4.5 mm cortex screws, and 4.0 mm cancellous screws.
Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
Stainless Steel and CP Titanium
Synthes Medial Distal Tibia Plates 510(k) Synthes (USA)
CONFIDENTIAL
000064
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Public Health Service
SEP 22 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) P.O. Box 1766 1690 Russell Road Paoli, Pennsylvania 19301
Re: K001945
Trade Name: Synthes (USA) Medial Distal Tibia Plates Regulatory Class: II Product Code: HRS Dated: June 23, 2000 Received: June 26, 2000
Dear Ms. Silvestri:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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
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Page 2 - Ms. Angela J. Silvestri
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific dayse for your astic devices), please contact the Office of Compliance at additionally 607.10 for in This anguestions on the promotion and advertising of your device, (201) 594-1639. Traditional (201) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsive at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Donna R. Lochner
GA 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 2.0
Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K001945
Synthes (USA) Medial Distal Tibia Plate Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular 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
Over-The-Counter Use __
Dume R. Lochner
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K001945
Synthes Medial Distal Tibia Plates 510(k) Synthes (USA)
CONFIDENTIAL
0000004
§ 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.