H-Max S stem

K160011 · Lima Corporate S.P.A. · MEH · Aug 22, 2016 · Orthopedic

Device Facts

• Record ID: K160011
• Device Name: H-Max S stem
• Applicant: Lima Corporate S.P.A.
• Product Code: MEH · Orthopedic
• Decision Date: Aug 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The H-MAX S stems are indicated for use in total and partial hip arthroplasty and are intended for pres-fit (uncemented) use. The H-MAS S stems are intended for use with CoCrMo femoral heads or Biolox Delta femoral heads and Limacorporate cemented acetabular cups or cementless Delta TT acetabular cups. In partial hip arthroplasty, H-MAX S stems are intended for use with Limacorporate Lock Bipolar heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia - Rheumatoid arthritis - Treatment of femoral head and neck fractures - Revisions in cases of good remaining femoral bone stock

Device Story

H-MAX S femoral system is a monolithic, cementless hip prosthesis; used in total or partial hip arthroplasty. Components include Ti6Al4V femoral stem with macro-roughened surface and hydroxyapatite coating; modular femoral heads (CoCrMo or Biolox Delta ceramic); and acetabular cups (cemented or Delta TT cementless). In partial arthroplasty, used with Lock Bipolar heads. Device implanted by orthopedic surgeons in clinical settings to reduce pain and improve hip function. System provides structural replacement for diseased or fractured femoral bone. Substantial equivalence based on design, material, and performance similarity to previously cleared H-MAX S stems and POLARSTEM system.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including validation of the hydroxyapatite coating per FDA guidance and range of motion analysis for the partial hip arthroplasty indication.

Technological Characteristics

Monolithic cementless femoral stem made of Ti6Al4V (ISO 5832-3, ASTM F1472). Features macro-roughened surface with hydroxyapatite coating. Available in 11 sizes across two configurations (conventional and lateralizing) with varying CCD angles. Modular design for use with CoCrMo or Biolox Delta ceramic femoral heads and Limacorporate acetabular cups.

Indications for Use

Indicated for skeletally mature patients requiring total or partial hip arthroplasty for non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, hip dysplasia), rheumatoid arthritis, femoral head/neck fractures, or revisions with good remaining femoral bone stock.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• H-MAX S Femoral Hip System H-MAX S stem (K112091, K150855)
• POLARSTEM Standard and Lateral Femoral Stems with Ti/HA (K130728)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

August 22, 2016

Limacorporate S.p.A. % Dr. Stephen J. Peoples President Peoples & Associates - Stephen J. Peoples, VMD, MS 411 Auditorium Blvd. Winona Lake, Indiana 46590

Re: K160011 Trade/Device Name: H-MAX S Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: MEH, JDI, KWY Dated: July 18, 2016 Received: July 21, 2016

Dear Dr. Peoples:

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

{1}------------------------------------------------

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 yours, Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K160011

Device Name H-MAX S stem

Indications for Use (Describe)

The H-Max S stems are indicated for use in total and partial hip arthroplasty and are intended for press-fit (uncemented) use. The H-Max S Stem are intended for use with CoCrMo femoral heads or Biolox Delta femoral heads and

Limacorporate cemented acetabular cups or cementless Delta TT acetabular cups. In partial Hip arthroplasty H-Max S stem is intended for use with Limacorporate Lock Bipolar heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

· non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;

· rheumatoid arthritis;

· treatment of femoral head and neck fractures;

· revisions in cases of good remaining femoral bone stock.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Summary of Safety and Effectiveness

Date: December 14, 2015

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy

US Contact Person: Stephen J. Peoples, VMD,MS Peoples & Associates 411 Auditorium Blvd Winona Lke, IN 46590 Phone: [phone] [e-mail]

| Product | Product Code | Regulation and Classification Name |
|----------------------------------------------|--------------|----------------------------------------------------------------------------------------------------------------------------|
| H-MAX S Stems<br>Class II medical<br>devices | MEH | Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous<br>uncemented prosthesis per 21 CFR<br>888.3353 |
| | JDI | Hip joint metal/polymer semi-constrained<br>cemented prosthesis per 21 CFR 888.3350 |
| | KWY | Hip joint femoral (hemi-hip<br>metal/polymer cemented or uncemented<br>prosthesis per 21 CFR 888.3390 |

### Description:

The H-MAX S femoral system consists of the H-MAX S femoral stem, a femoral head and an acetabular cup. In total hip arthroplasty, the H-MAX S stems are intended for use with modular CoCrMo femoral heads or Bioloz Delta ceramic femoral heads and a compatibile Limacorporate Cemented Cup or uncemented Delta TT acetabular cup. When used in partial hip arthroplasty, H-MAX S stems are intended for use with Limacorporate Lock Bipolar Heads.

The H-MAX S femoral stem is a monolithic cementless stem made from Ti6Al4V (ISO 5832-3, ASTM F1472). The external surface has a macro-roughened surface. A layer of hydroxyapatite is applied along the length of the stem. The H-MAX S stem is manufactured in 11 sizes for each of two configurations (conventional and lateralizing) that vary in the CCD angle.

{4}------------------------------------------------

#### Intended Use:

The H-MAX S stems are indicated for use in total and partial hip arthroplasty and are intended for pres-fit (uncemented) use. The H-MAS S stems are intended for use with CoCrMo femoral heads or Biolox Delta femoral heads and Limacorporate cemented acetabular cups or cementless Delta TT acetabular cups. In partial hip arthroplasty, H-MAX S stems are intended for use with Limacorporate Lock Bipolar heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia
- Rheumatoid arthritis
- Treatment of femoral head and neck fractures
- Revisions in cases of good remaining femoral bone stock

#### Predicate Devices:

- H-MAX S Femoral Hip System H-MAX S stem (Limacorporate, K112091 and . K150855)
- . POLARSTEM Stabdard and Lateral Femoral Stems with Ti/HA (Smith and Nephew, Inc. K130728)

#### Comparable Features to Predicate Device(s):

H-MAX S Stems are exactly the same devices already cleared via K112091 and K150855. The only changes involve:

- Introduction of a new supplier for the HA coating (the subject device is . substantially equivalent to the H-MAX S Stems already cleared):
- . Introduction of the indication for partial hip arthroplasty (the subject device is substantially equivalent to the POLARSTEM).

### Non-Clinical Testing:

The materials, design, femoral head sizes and acetabular components remain the same as described in previously cleared submissions. All non-clinical testing performed for the previous submissions of H-MAX S Stems remain applicable. The changes of this submission were evaluated through:

- Validation of the HA coating in accordance with FDA Guidance "510(k) . Information needed for hydroxyapatite coated orthopedic implants";
- . Analysis of the Range of Motion for the H-MAX S Stem coupled with Lock Bipolar Heads for the indication of partial hip arthroplasty.

The testing results demonstrated the system's ability to perform substantially equivalent to the predicate devices considered.

{5}------------------------------------------------

## Clinical Testing:

Clinical testing g was not necessary to demonstrate substantial equivalence of the H-MAX S Stems to the predicate devices.