IDEAL Locking Plate System

K141825 · Jiangsu Ideal Medical Science & Technology Co., LT · HRS · Mar 3, 2015 · Orthopedic

Device Facts

• Record ID: K141825
• Device Name: IDEAL Locking Plate System
• Applicant: Jiangsu Ideal Medical Science & Technology Co., LT
• Product Code: HRS · Orthopedic
• Decision Date: Mar 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ideal® locking plate system is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

Device Story

Ideal® Locking Plate System consists of metallic bone plates, cortical screws, locking screws, and surgical instruments. Used for internal fixation of distal femur fractures; plates provide structural support (buttressing) to bone fragments; screws secure plates to bone. Operated by orthopedic surgeons in clinical/surgical settings. System stabilizes fractures to facilitate healing; intended for use in normal or osteopenic bone.

Clinical Evidence

Bench testing only. Compliance with ASTM F382-99 (static/dynamic four-point bending for plates) and ASTM F543-07 (torsional properties, driving torque, pull-out test for screws) demonstrated performance equivalent to predicates.

Technological Characteristics

Bone plates: unalloyed titanium (ASTM F67). Cortical/locking screws: Ti6Al4V ELI (ASTM F136). Mechanical fixation via locking plate/screw interface. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for patients with multifragmentary distal femur fractures, including supra-condylar, intra-articular, and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions, and malunions.

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 Bone Plates and Scews (K130340)
• Synthes 4.5mm VA-LCP Curved Condylar Plate System (K110354)
• Double Engine Bone Plate and Bone Screw Systems (K130108)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

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

Jiangsu Ideal Medical Science & Technology Co., Ltd % Ms. Alice Gong Shanghai Yarui Consultant Co., Ltd. 503 Room. 8 Building. 600 Liu Zhou Road Shanghai 200233 China

March 3, 2015

Re: K141825 Trade/Device Name: Ideal® Locking 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 Dated: November 18, 2014 Received: January 2, 2015

Dear Ms. Alice Gong.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K141825

Device Name

Ideal® Locking Plate System

Indications for Use (Describe)

Ideal® locking plate system is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# [苏艾迪尔医疗科技股份有限公司

Section 5 of Traditional 510(K) Submission:

510 (K) Summary

# This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92

- 1. Date of Submission: Feb. 23, 2015
- 2. Submitter / 510(K) Holder

Jiangsu Ideal Medical Science & Technology Co., Ltd. East Area, Jinfeng Industry Park Zhangjiagang City Jiangsu Province, China 215625

Contact Person: Miss Li Wei Tel: [phone] Fax: [phone] E-mail: [e-mail]

# 3. Proposed Device Name

Trade name: Ideal® Common name: Locking Plate System

Classification Name: Plate, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HRS Regulation Number: 21 CFR 888.3030

Classification Name: Screw, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HWC Regulation Number: 21 CFR 888.3040

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#### 4. Predicate Devices

#### Predicate Device #1:

510 (k) Number: K130340 Product Name: Locking Bone Plates and Scews Submitter: Weigao Orthopaedic Device Co., Ltd.

#### Predicate Device #2:

510 (k) Number: K110354 Product Name: Synthes 4.5mm VA-LCP Curved Condylar Plate System Submitter: Synthes

#### Predicate Device #3:

510 (k) Number: K130108 Product Name: Double Engine Bone Plate and Bone Screw Systems Submitter: Xiamen Double Engine Medical Material Co., Ltd.

#### 5. Device Description

Ideal® locking plate system contains locking plates with various specifications, cortical and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.

The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The cortical and locking screws are made of Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

#### 6. Indication for Use/Intended Use

Ideal® locking plate system is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

#### 7. Non-Clinical Testing

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

ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates, including the following items:

* Static four point bending

- * Dynamic four point bending

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ASTM F 543-07, Standard Specification and Test Metallic Medical Bone Screws including the following item:

- * Torsional properties
- * Driving torque
- * Pull out test

# 8. Substantially Equivalent Conclusion

The intended use of Ideal® locking plate system is same as that of the predicate device #2 and The intended use of Ideal® locking plate system is less than that of the predicate device #1 and #3.

Ideal® locking plate system has similar technological characteristics as all predicate devices.

The proposed device, the Ideal® locking plate system, is determined to be Substantially Equivalent (SE) to the predicate device, K130340 locking bone plates and screws, K110354 Synthes 4.5mm VA-LCP Curved Condylar Plate System and K130108 Double Engine Bone Plate and Bone Screw Systems, in respect of safety and effectiveness.