METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM

K131759 · Tianjin Walkman Biomaterial Co., Ltd. · HRS · Aug 8, 2013 · Orthopedic

Device Facts

• Record ID: K131759
• Device Name: METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
• Applicant: Tianjin Walkman Biomaterial Co., Ltd.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Metallic Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

Device Story

System consists of titanium locking compression plates (LCPs), locking screws, cortex screws, and surgical instruments. Plates feature combi-holes: threaded sections for locking screws to create fixed-angle constructs; un-threaded sections for cortex screws to allow standard AO plating techniques. Limited-contact design reduces plate-to-bone contact to minimize vascular trauma. Used by orthopedic surgeons in clinical/OR settings for fracture fixation. Device is non-sterile, single-use, and requires steam sterilization prior to use. Output is mechanical stabilization of bone fractures, aiding healing and patient recovery.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing per ASTM F382-99 (plates) and ASTM F543-07 (screws), including static/dynamic performance, torsional, driving torque, and pull-out strength testing.

Technological Characteristics

Materials: Titanium (plates), Titanium alloy (screws). Design: Locking compression plates with combi-holes (threaded/un-threaded). Standards: ASTM F382-99 (plates), ASTM F543-07 (screws). Energy: None (mechanical). Connectivity: None. Sterilization: Steam (non-sterile as supplied).

Indications for Use

Indicated for adult patients >21 years old for fixation of fractures of the ulna, radius, humerus, femur, and tibia.

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

• Locking Compression Plate (K101400)
• Locking Bone Screw (K100721)
• Trauson Bone Screw (K073159)

Submission Summary (Full Text)

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#### AUG 8 2013 K131759

Project #: M0152013Ad Section 3 510k Summary Premarket Notification 510(k) Submission

## Section 3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: J

- 3.1 Date of Submission
06/07/2013

- 3.2 Sponsor Identification
Tianjin Walkman Biomaterial Co., Ltd No. 19, Technology Road, Tianjin Tianyu Science and Technology Garden Jinghai East, Tianjin, P.R. China 301609

Establishment Registration Number: Not yet registered

Contact Person: Ms. Fengmei Ren Position: Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- 3.3 Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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#### K131759

#### Project #: M0152013Ad Section 3 510k Summary Premarket Notification 510(k) Submission

#### 3.4 Proposed Devices Identification

Proposed Device Name: Metallic Locking Bone Plates and Metallic Locking Bone Screws

Regulatory Information of Plates: Classification Name: Plate, Fixation, Bone Common Name: Bone Plates Class: Class II Product Code: HRS Regulation Number: 21 CFR 888.3030 Review Panel: Orthopedic

Regulatory Information of Screws: Classification Name: Screw, Fixation, Bone Common Name: Bone Screws Class: Class II Product Code: HWC Regulation Number: 21 CFR 888.3040 Review Panel: Orthopedic

Intended Use Statement:

Metallic Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

#### 3.5 Device Description

Metallic Locking Compression Bone Plates and Screws System contains (1) locking compression plates (LCPs) with various specifications, (2) two kinds of screws with various specifications and (3) various specific instruments. Locking Compression Plates that made of Titanium. They have combi-holes. the threaded hole sections on the plates for locking screws provides ability to create fixed-angle constructs; the un-threaded hole sections for cortex screws allows utilization of familiar AO plating techniques. The limited-contact design of LCPs reduces plate-to-bone contact, thus limiting vascular trauma.The screws are available in locking screws and cortex screws. There are various instruments specific to the proposed device intend for completing the surgery.

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#### Premarket Notification 510(k) Submission Section 3 510k Summary

Project #: M01 52013Ad

## 3.6 Predicate Device Identification

Predicate Device 1

.

510(k) Number K101400

Predicate Device Name Locking Compression Plate

Manufacturer Changzhou Orthmed Medical Instrument Co., Ltd

#### Predicate Device 2

. 510(k) Number K100721

> Predicate Device Name . Locking Bone Screw

Manufacturer Changzhou Orthmed Medical Instrument Co., Ltd

## Predicate Device 3

510(k) Number K073159

Predicate Device Name Trauson Bone Screw

Manufacturer Trauson (Jiangsu) Medical Instrument Co., Ltd

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## 3.7 Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone a) Plates.
- ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws. b)
- 3.8 Clinical Testing Conclusion

No clinical study is included in this submission.

- 3.9 Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Device | Predicate Device<br>1 | Predicate Device<br>2 | Predicate Device<br>3 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HRS<br>HWC | HRS<br>/ | /<br>HWC | /<br>HWC |
| Regulation Number | 21 CFR 888.3030<br>21 CFR 888.3040 | 21 CFR 888.3030<br>/ | /<br>21 CFR 888.3040 | /<br>21 CFR 888.3040 |
| Intended Use | Metallic Locking<br>Compression Bone<br>Plate and Screw<br>System is intended for<br>adult patients with age<br>above 21 as indicated<br>for fixation of<br>fractures, including<br>ulna, radius, humerus,<br>femur and tibia. | Locking Compression<br>Plate can be used for<br>adult patients with age<br>above 21 as indicated<br>for fixation of<br>fractures, including<br>ulna, radius, humerus,<br>femur and tibia. | Locking Bone Screw<br>is indicated for bone<br>reconstruction,<br>osteotomy,<br>arthrodesis, joint<br>fusion, fracture repair,<br>and fracture fixation<br>of bones appropriate<br>for the size of the<br>device. | Trauson Bone Screw<br>is indicated for bone<br>reconstruction,<br>osteotomy.<br>arthrodesis, joint<br>fusion, fracture repair,<br>and fracture fixation<br>of bones appropriate<br>for the size of the<br>device. |
| Material | Plate: Titanium<br>Cortex Screw:<br>Titanium alloy<br>Locking Screw: | Plate: Titanium<br>/<br><br>/ | /<br>/<br><br>Locking Screw: | /<br>Cortex Screw:<br>Stainless Steel<br>/ |

Table 3-1 Comparison of Technology Characteristics

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| | Titanium alloy | | Titanium alloy | |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| How supplied | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Single Use | Yes | Yes | Yes | Yes |
| Sterile | Subject to steam<br>sterilized prior to use. | Subject to steam<br>sterilized prior to use. | Subject to steam<br>sterilized prior to use. | Subject to steam<br>sterilized prior to use. |
| Performance | Static and Dynamic<br>Performance tested<br>per ASTM F382<br>Torsional, Driving<br>Torque and Pull out<br>strength tested per<br>ASTM F543. | Static and Dynamic<br>Performance tested<br>per ASTM F382 | Torsional, Driving<br>Torque and Pull out<br>strength tested per<br>ASTM F543. | Torsional, Driving<br>Torque and Pull out<br>strength tested per<br>ASTM F543. |

Differences in intended use, material and performance between the proposed and predicate device have been discussed and address. The proposed device is determined to be Substantially Equivalent (SE) to the predicate devices, in respect of safety and effectiveness.

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Image /page/5/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is smaller than the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2013

Tianiin Walkman Biomaterial Company, Limited % Mid-Link Consulting Company, Limited Ms. Diana Hong General Manager PO Box 120-119 Shanghai, 200120, China

Re: K131759

Trade/Device Name: Metallic Locking Compression Bone Plates and Screws System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS, HWC Dated: July 19, 2013 Received: July 22, 2013

Dear Ms. Hong:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Ms. Diana Hong

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours.

Erin I. Keith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 2 Indications for Use

## Section 2 Indications for Use

K131759 510(k) Number: Device Name: Metallic Locking Compression Bone Plates and Screws System

Indications for Use:

Mctallic Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OR

[]over-the-counter use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Elizabeth L. Frank -S

Division of Orthopedic Devices