MICROWARE BONE PLATES AND BONE SCREWS
Device Facts
| Record ID | K072562 |
|---|---|
| Device Name | MICROWARE BONE PLATES AND BONE SCREWS |
| Applicant | Microware Precision Co., Ltd. |
| Product Code | HRS · Orthopedic |
| Decision Date | Dec 4, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges). Microware DHS/DCS Plate System is provided non-sterile. Microware DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture.
Device Story
System of non-sterile metallic bone plates and screws for orthopedic fracture fixation. Plates include DCP, tubular, special, mini, and DHS/DCS styles; screws include cortex, cancellous, malleolar, and cannulated types. Used by surgeons in clinical/OR settings to stabilize bone fragments. Plates fastened to bone; screws provide fixation or act as lag screws to hold fragments. Hexagonal recess in screws facilitates insertion/removal. DHS/DCS system specifically for proximal femur; includes compression screws to achieve fracture compression. Provides mechanical stability to promote bone healing.
Clinical Evidence
No clinical data provided; substantial equivalence based on design, material, and performance characteristics compared to predicate devices.
Technological Characteristics
Materials: 316L stainless steel (ASTM F138, F139) and titanium alloy (Ti-6Al-4V, ASTM F136). Mechanical fixation via plates and screws. Plate thickness 1.0-6.0mm, width 3.8-17mm, length 17-359mm. Screw diameters 1.5-7.3mm. Non-sterile delivery.
Indications for Use
Indicated for patients with fractures of the clavicle, pelvis, scapula, long bones (humerus, ulna, radius, femur, tibia, fibula), and small bones (metacarpals, metatarsals, phalanges). DHS/DCS system indicated for proximal femur fractures including trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
Regulatory Classification
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.
Predicate Devices
- Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495)
- Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873)
- INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System (K063020)
Submission Summary (Full Text)
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# 3. 510(k) Summary of Safety and Effectiveness
Submitter's Name: Microware Precision Co., Ltd.
DEC 0 4 2008
Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Phone No: +886-4-24636275 Fax No: +886-4-24636276
Contact Person: Harrison Du
Preparation date: April 7, 2008
Registration Number:
Device Name: Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System
Proprietary Name: Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System
Common Name: Bone Fixation Plate and Screw
**Classification Name**
Classification Name: Class II: Plate, Fixation, Bone HRS-CFR 888.3030 Class II: Screw, Fixation, Bone HWC-CFR 888.3040 Class II: Appliance, fixation, nail/blade/plate Combination, multiple component KTT-CFR 888.3030
Product Code: HRS, HWC, KTT
Panel Code: Orthopedic/87
Microware Precision Co., Ltd.
510(k) submission 2008
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# K072562 (pg. 2 of
# Predicate Device Information:
Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495) Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873) INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System (K063020)
### Materials:
The non-sterile bone plates and screws are manufactured from commercial medical use 316L stainless steel that meet ASTM F138 and ASTM F139, and titanium alloy (Ti-6Al-4V) that meet ASTM F136.
## Indication for use:
Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).
Microware DHS/DCS Plate System is provided non-sterile. Microware DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, and basilar neck fracture.
## Device Description:
The Bone Plates and Bone Screws system & DHS/DCS Plate System consist of non-sterile bone plate and bone screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. They are principally differentiated by their function. Thus there are five kinds of styles: dynamic compression plate (DCP), tubular, special, mini and dynamic hip screw/dynamic condylar screw (DHS/DCS). The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. Every plate is divided various types as following:
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Microware Precision Co., Ltd.
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KOT2562 (Pg. 30f4)
| Special | L-shaped, T-shaped, spoon, cobra, lateral tibia head, condylar<br>buttress, head, and hook |
|---------|--------------------------------------------------------------------------------------------|
| Mini | Straight, L-shaped, T-shaped, condylar, special, and<br>reconstruction |
| DHS/DCS | Dynamic Hip Screw, Dynamic Condylar Screw |
The series in size of Microware bone screws and bone plates except DHS/DCS are divided into mini, small and large. The range of plates in thickness are from 1.0 to 6.0 mm, width from 3.8 to 17 mm, length from 17 to 359 mm, and hole number from 2 to 22 holes.
On the other hand, the screws used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Thus there are four kinds of style: cortex, cancellous, malleolar, and cannulated. All screws have a hexagonal recess; this feature has proven itself to be of great advantage at the time of the screw removal and insertion. The range of screws in thread is diameter from 1.5 to 7.3 mm, total length from 6 to 150 mm.
The DHS/DCS Plate System consists of DHS/DCS plate, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5mm Cortex Screw (self-tapping). The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95', 135 , 140', 145', and 150'. The self-tapping 4.5mm Cortex Serew can be used to fix the DHS/DCS Plate to the femoral shaft.
The DHS/DCS Screw is available in total length from 50 to 145mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter 12.5 to 14mm. The thread of DHS/DCS screw has a buttress type.
The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26mm and outer diameter 4.0mm.
#### Substantial Equivalence:
A comparison between the proposed device and the predicate device has shown that three devices are very similar or identical in terms of indication for use, material, followed performance and standard and sterilization, and no significant difference between the proposed and predicate devices has been found. Thus, the "Microware Bone Plates and Bone Screws &
Microware Precision Co., Ltd
510(k) submission 200
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Microware DHS/DCS Plate System" is substantially equivalent to Syntec-Taichung Non-sterile Bone Plate and Screw implants (K983495), Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873), and INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System (K063020).
Microware Precision Co., Ltd.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) submission 2008
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle-like symbol in the center, with its wings forming three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Microware Precision Co., Ltd. c/o Mr. Harrison Du General Manager No. 12. Keyuan 2nd Rd. Situn District Taichung City 40763, TAIWAN
### DEC 0 4 2008
Re: K072562
Trade/Device Name: Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and
accessories Regulatory Class: Class II Product Code: HRS, HWC, KTT Dated: October 22, 2008
Received: November 3, 2008
Dear Mr. Du:
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
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#### Page 2 - Mr. Harrison Du
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 (OS) 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 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 Biometrics' (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 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,
Mark N. Millenson
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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#### Indications for Use 2.
# 510(k) Number (if known): Ko 72562
Device Name: Microware Bone Plates and Bone Screws Indications for Use:
Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).
Microware DHS/DCS Plate System is provided non-sterile. Microware DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture.
Prescription Use (Part 21 CFR 801 Subpart D
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | |
|---------------|--|
|---------------|--|
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K072562 |
|---------------|---------|
|---------------|---------|
510(k) submission 2008
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