(62 days)
The SBi rHead Plating System is indicated for fractures of the proximal radius.
The SBi rHead Plating System consists of various plates and screws to treat fractures of the proximal radius. SBi plans to offer two plate designs: the rHead Neck Plate and the rHead Rim Plate. Both have a curved, T-shaped design to match the geometry of the proximal radius. Both will be available in a variety of neck widths, plate lengths, and hole geometries (threaded and non-threaded). Locking and non-locking screws will be included as part of the SBi rHead Plating System.
The provided document is a 510(k) summary for a medical device (SBi rHead Plating System). It is a regulatory submission for market clearance and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on:
- Device Description: The SBi rHead Plating System consists of plates and screws for proximal radius fractures.
- Intended Use: Fractures of the proximal radius.
- Material: Stainless steel.
- Substantial Equivalence: The manufacturer claims the device is substantially equivalent to other legally marketed devices, which is the basis for 510(k) clearance.
Therefore, I cannot provide the requested information from the given text as it is not present in the document. This type of submission relies on demonstrating similarity to existing devices, rather than presenting clinical or performance data against specific acceptance criteria.
{0}------------------------------------------------
:
510(k) Summary
| Manufacturer: | Small Bone Innovations International, SAZ.A. Les BruyeresPeronnas France 01960 | AUG - 7 2007 |
|---|---|---|
| Submitted By: | Small Bone Innovations1380 South Pennsylvania AvenueMorrisville, PA 19067 | |
| Proprietary Name: | SBi rHead Plating System | |
| Classification name: | Class II, 888.3030 - Single / multiple component bonefixation appliances and accessories | |
| Common/Usual Name: | Bone fixation plate | |
| Product Code: | HRS | |
| Substantial Equivalence: | Documentation is provided which demonstrates the SBirHead Plating System to be substantially equivalent to otherlegally marketed devices. | |
| Device Description: | The SBi rHead Plating System consists of various platesand screws to treat fractures of the proximal radius. SBiplans to offer two plate designs: the rHead Neck Plate andthe rHead Rim Plate. Both have a curved, T-shaped designto match the geometry of the proximal radius. Both will beavailable in a variety of neck widths, plate lengths, and holegeometries (threaded and non-threaded). Locking and non-locking screws will be included as part of the SBi rHeadPlating System. | |
| Intended Use: | The SBi rHead Plating System is indicated for fracturesof the proximal radius. | |
| Material: | The implants are made from stainless steel (ASTM F138). |
:
{1}------------------------------------------------
Image /page/1/Picture/13 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of curved lines. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations Inc. % Mr. Robert Hoehn Senior Regulatory Associate 505 Park Ave. 14th Floor New York, New York 10022
AUG - 7 2007
Re: K071549 Trade/Device Name: SBi rHead Plating System Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II
Product Code: HRS Dated: June 4, 2007 Received: June 6, 2007
Dear Mr. Hoehn:
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 – Mr. Robert Hoehn
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) 276-0120. 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 yours,
Barbare Byerly
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
K071549 (pg 1/1)
Indications for Use
510(k) Number:
Device Name: SBi rHead Plating System
Indications For Use:
The SBi rHead Plating System is indicated for fractures of the proximal radius.
Prescription Use √ (Part 21 CFR 801 Subpart D) 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)
Page 1 of 1
Barbara Buchm
(Div ion-Division of General, Restorative, and Neurological Devices
510(k) Number K071549
§ 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.