BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG

K120924 · Corentec Co., Ltd. · LPH · Sep 10, 2012 · Orthopedic

Device Facts

• Record ID: K120924
• Device Name: BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
• Applicant: Corentec Co., Ltd.
• Product Code: LPH · Orthopedic
• Decision Date: Sep 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bencox Mirabo Cup System is intended for use in total hip arthroplasty in primary or revision surgery for the following conditions: a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis b. Inflammatory degenerative joint disease, such as rheumatoid arthritis c. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip arthroplasty

Device Story

Bencox Mirabo Cup System is a modular acetabular component for total hip arthroplasty; consists of porous-coated titanium alloy (Ti-6Al-4V) outer shell and highly crosslinked UHMWPE liner. Liner locks into shell and articulates with femoral head. Used by orthopedic surgeons in clinical settings for primary or revision hip replacement. System includes acetabular cup, PE inserts, bone screws, and instrumentation. Provides stable prosthetic interface for hip joint reconstruction; restores joint function and reduces pain in patients with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via wear, liner torsion, lever out, push out, and impingement testing in accordance with ISO 14242, ASTM F1820, and ASTM F2582 standards.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136) and UHMWPE (ASTM F648). Components: Porous-coated non-hemispherical shell, locking liner, bone screws. Sterilization: Gamma irradiation (cup), ethylene oxide (liner). Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis, traumatic arthritis), inflammatory degenerative joint disease (e.g., rheumatoid arthritis), non-union, femoral neck/trochanteric fractures of the proximal femur, or failed previous hip surgery.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Coren Total Hip System (K103431)
• Pinnacle Acetabular System (K000306)

Submission Summary (Full Text)

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K/20924

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Bencox Mirabo Cup System

1 0 2012

# 510(K) SUMMARY Corentec Co., Ltd. Bencox Mirabo Cup System Mar 25th, 2012

### ADMINISTRATIVE INFORMATION

Special 510(k): Device Modification

Manufacturer Corentec Co., Ltd. 247 Giro-ri, Ipjang-myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, 331-822 South Korea Telephone: [phone] Fax: [phone]

Official Contact J.S. Daniel Project Manager - RA/QA Corentec Co., Ltd 11th Chungho Tower, 748-1 Banpo 1 Dong Seocho Gu, Seoul, Korea 137-040 Ph: [phone] Fax: [phone] Email: [e-mail]

# DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | Bencox Mirabo Cup System |
|-----------------------------|---------------------------|
| Common Name: | Acetabular Cup System |
| Classification Regulations: | 21 CFR 888.3358 |
| Class: | II |
| Product Codes: | LPH |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |

#### INTENDED USE

The intended use of the modified device [Bencox Mirabo Cup System] has not changed as a result of the modification of the predicate device [Bencox (Coren) Total Hip System], cleared under K103431.

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/20924

### Special 510(k): Device Modification

The Bencox Mirabo Cup System is intended for use in total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

c. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists

e. Revision of previously failed total hip arthroplasty

#### DEVICE DESCRIPTION

The Bencox Mirabo Cup System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated non hemispherical outer shell manufactured from titanium alloy (Ti-6AI-4V) and a liner manufactured from highly crosslinked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.

The Acetabular system consists of Bencox Mirabo Cup, Bencox Mirabo PE Inserts (Standard & Elevated), Bencox Bone Screw, Dome hole & Screw Hole Plugs; and Bencox THR Instrumentation. The components are manufactured from the following materials: Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); and ultra-high molecular weight polyethylene conforming to ASTM F648, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. The acetabular cup is sterilized by gamma irradiation and acetabular liner is sterilized by ethylene oxide, same as its predicate device cleared under K103431.

#### SUBSTANTIAL EQUIVALENCE

Bencox Mirabo Cup System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent, as below,

- Corentec Co., Ltd., Coren Total Hip System (now renamed as Bencox Total Hip . System) cleared under K103431
- DePuy Orthopedics Inc., Pinnacle Acetabular System cleared under K000306 .

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# Special 510(k): Device Modification

### PERFORMANCE DATA

Performance testing was carried out to demonstrate substantial equivalence and included methods described in the following standards: ISO 14242, ASTM F1820 and ASTM F2582. Mechanical testing of the subject device consisted of wear, liner torsion & lever out, push out and impingement testing. The acetabular cup system performed either similar or better than the predicate devices.

Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.

Overall, the Bencox Mirabo Cup has similarities to the predicate devices with the same intended use, same fundamental scientific technology, same operating principles, same materials and are supplied Sterile.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

SEP 10 2012

Corentec Company, Limited % Mr. J.S. Daniel Project Manager. Regulatory Affairs and Quality Assurance 8th Chungho Tower, 748-1 Banpo 1 Dong Seocho Gu, Seoul, Korea 137-040

Re: K120924

Trade/Device Name: BENCOX MIRABO CUP SYSTEM Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coat-ed uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: August 08, 2012 Received: August 13, 2012

Dear Mr. Daniel:

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

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#### Page 2 - Mr. J.S. Daniel

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Fan Dath, Cur

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

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known):

#### Device Name: BENCOX MIRABO CUP SYSTEM

The Bencox Mirabo Cup System is intended for use in total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

d. Patients with failed previous surgery where pain, deformity, or dysfunction persists

e. Revision of previously failed total hip arthroplasty

Prescription Use: X (Per 21 CFR 801 Subpart D) AND / OR

Over-The Counter Use:-(Per 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)

yhitet Pe

120924

Difision Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

.510(k) Number

Corentec Co. Ltd