(19 days)
The Smith & Nephew Locking Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Components in the Smith & Nephew Locking Bone Plate System are for single use only.
The Smith & Nephew Locking Bone Plate System is a modification of the Smith & Nephew Bone Plate System cleared under K993106. Like the predicate devices listed below, components include various sizes of contoured and straight, locking bone plates, locking bone screws, and compression screws made from stainless steel. Implantable locking plates/screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
The provided text does not contain information about acceptance criteria, device performance, or any studies with specific details like sample sizes, ground truth establishment, or expert involvement. The document is a 510(k) summary for the Smith & Nephew Locking Bone Plate System, primarily focused on establishing substantial equivalence to previously cleared predicate devices.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the specified information.
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| DEC 1 0 2003 | 510(k) Summary of Safety and EffectivenessSmith & Nephew Locking Bone Plate System | K033669page 1 of 1 |
|---|---|---|
| Submitted By: | Smith & Nephew, Inc., Orthopaedic Division1450 Brooks Road, Memphis, TN 38116 | |
| Date: | November 20, 2003 | |
| Contact Person: | David Henley, Senior Clin/Reg Affairs SpecialistTel: (901) 399-6487 Fax: (901) 398-5146 | |
| Proprietary Name: | Smith & Nephew Locking Bone Plate System | |
| Common Name: | Bone Plates and Bone Screws | |
| Classification Name and Reference: | 21 CFR 888.3030, single/multiple componentmetallic bone fixation appliances and accessoriesClass II21 CFR 888.3040, smooth or threaded metallic bonefixation fastener - Class II |
Device Product Code and Panel Code:
Device Description:
The Smith & Nephew Locking Bone Plate System is a modification of the Smith & Nephew Bone Plate System cleared under K993106. Like the predicate devices listed below, components include various sizes of contoured and straight, locking bone plates, locking bone screws, and compression screws made from stainless steel. Implantable locking plates/screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
HRS and HWC / Orthopedics / 87
Intended Use:
The Smith & Nephew Locking Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, humerus, ulna, middle hand and middle foot bones (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Technological Characteristics:
Components from the Smith & Nephew Locking Bone Plate System are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials and incorporate similar technological characteristics.
Substantial Equivalence Information:
When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition.
- Smith & Nephew Bone Plate System K993106 .
- Synthes Small Fragment Locking Compression Plate (LCP) - K000684
- Synthes Locking Calcaneal Plate K991407 .
- Synthes LCP for the Distal Femur K000066 .
- Synthes LCP for the Proximal Tibial K011978 .
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DEC 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Henley Senior Clinical/ Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K033669
Trade/Device Name: Smith & Nephew Locking Bone Plate System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: November 20, 2003 Received: November 21, 2003
Dear Mr. Henley:
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 – Mr. David Henley
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.huml
Sincerely yours,
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 Smith & Nephew Locking Bone Plate System
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Smith & Nephew Locking Bone Plate System
Indications for Use:
The Smith & Nephew Locking Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Components in the Smith & Nephew Locking Bone Plate System are for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Wilkinson
ു. Restorative
Page Number:__
Prescription Use (Per 21 CFR 801.109)
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Over-The Counter Use (Optional Format 1-2-96)
§ 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.