MALUC™ Total Hip Arthroplasty System

K162125 · Surgtech, Inc. · JDI · May 10, 2017 · Orthopedic

Device Facts

• Record ID: K162125
• Device Name: MALUC™ Total Hip Arthroplasty System
• Applicant: Surgtech, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: May 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.

Device Story

MALUC™ Total Hip Arthroplasty System is a prosthetic hip replacement system for primary total hip arthroplasty. Components include monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads, uncemented acetabular shells, and conventional polyethylene liners. Accessory components include distal centralizers, cancellous bone screws, and cement restrictors. The device is implanted by orthopedic surgeons in a clinical/surgical setting to replace a diseased or damaged hip joint. The system restores joint function, reduces pain, and improves mobility for patients suffering from degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through non-clinical mechanical testing in accordance with ISO 21535, ISO 7206-4, ISO 7206-6, ISO 7206-10, ASTM F2996, ASTM F2009, ASTM F1820, and ASTM F543, and bacterial endotoxin testing per USP <85> and ANSI/AAMI ST72.

Technological Characteristics

System includes CoCr and BIOLOX® delta femoral heads, uncemented acetabular shells, and conventional polyethylene liners. Materials and mechanical performance validated per ISO 21535, ASTM F2996, ISO 7206-4/6/10, ASTM F2009, ASTM F1820, and ASTM F543. Sterilization and endotoxin testing per USP <85> and ANSI/AAMI ST72.

Indications for Use

Indicated for skeletally mature patients with severely painful/disabled hip joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture, failed previous hip surgery, or ankylosis.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• DePuy SUMMIT (K023453)
• Stryker Exeter V40 (K011623)
• Stryker Accolade TMZF (K032300)
• Stryker Trident (K040412, K991952, K022077, K010757, K070885)
• Depuy PINNACLE with GVF Liner (K000306)

Submission Summary (Full Text)

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

May 10, 2017

SurgTech, Inc., % Kellen Hills Quality And Regulatory Consultant Orchid Design 4600 E Shelby Dr Memphis. Tennessee 38118

Re: K162125

Trade/Device Name: MALUCTM Total Hip Arthoplasty System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LPH, LZO Dated: April 7, 2017 Received: April 11, 2017

Dear Mr. Hills:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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,

# 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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#### Indications for Use

Form Approved: QMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known)

#### K 162125 (Page 1 of 1)

#### Device Name

MANDO Fotal Fotal Bo

#### Indications for Use (Describe)

The Surg Tech MALL C ™ System is intended for use for cases of severely painful and or disabled joint from osteoarthritis, traumatic arthritis or congenital hip dysplasia, avascular necrosis of the femoral head acute traumatic fracture of the femoral head or neck, failed previews hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and or total arthroplasty), and certain cases of ankylos

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

Prescription Use (Part 21 CFR 801 Subpart D).

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

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

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| (a)(1) | Submitted By: | SurgTech, Inc.<br>24600 Center Ridge Road, Suite 195<br>Westlake, OH 44145 |
|--------|------------------------------------|----------------------------------------------------------------------------|
| | Phone: | 901-433-1990 |
| | Fax: | 901-433-1989 |
| | Date: | April 7, 2017 |
| | Contact Persons | |
| | Primary: | Kellen Hills (Orchid Design Consulting) |
| | Secondary: | Brian Hewko (SurgTech, Inc.) |
| (a)(2) | Proprietary Name: | MALUC™ Total Hip Arthroplasty System |
| | Common Name: | Total Hip Prosthesis |
| | Classification Name and Reference: | 21CFR 888.3350, 888.3358, 888.3353 |
| | Product Code: | JDI, LPH, LZO |

- (a)(3) Predicate Devices: Primary:
Additional:

DePuy SUMMIT (K023453);

Stryker Exeter V40 (K011623); Stryker Accolade TMZF (K032300); Stryker Trident (K040412, K991952, K022077, K010757, K070885); Depuy PINNACLE with GVF Liner (K000306);

- (a)(4) Device Description:
The MALUC™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads in various sizes and offsets, uncemented acetabular shells and conventional polyethylene liners. Accessory components include distal centralizers, cancellous bone screws and cement restrictors. Instrumentation necessary for proper implantation is also included.

The purpose of this submission is to gain initial marketing authorization in the United States.

(a)(5) Indications for Use:

> The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.

- Comparison of Technological Characteristics: (a)(6) The MALUC™ Total Hip Arthroplasty System is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, packaging, sterilization and

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mechanical performance. The technological characteristics do not raise any new questions of safety and efficacy.

- (b)(1) Non-clinical testing:
Mechanical testing in accordance with the following standards was performed and the subject MALUC™ THA System met all predetermined acceptance criteria: ISO 21535, ASTM F2996, ISO 7206-4, ISO 7206-6, ISO 7206-10, ASTM F2009, ASTM F1820, ASTM F543.

Bacterial endotoxin testing was performed in accordance with USP <85> and ANSI/AAMI ST72 and met the predetermined acceptance criteria.

#### (b)(2) Clinical testing:

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

#### (b)(3) Conclusions:

Based on the information provided in this premarket notification, we believe that the subject MALUC™ Total Hip Arthroplasty System demonstrates substantial equivalence to the identified predicate devices.