AMIStem-C

K193433 · Medacta International S.A. · LZO · Jan 9, 2020 · Orthopedic

Device Facts

• Record ID: K193433
• Device Name: AMIStem-C
• Applicant: Medacta International S.A.
• Product Code: LZO · Orthopedic
• Decision Date: Jan 9, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The hip prosthesis AMStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia • Avascular necrosis of the femoral head • Acute traumatic fracture of the femoral head or neck • Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

Device Story

AMIStem-C is a straight, triple-tapered, rectangular cross-section femoral stem for cemented total or partial hip arthroplasty. Used in primary or revision surgery; implanted by orthopedic surgeons. Device features mirror-polished neck and body to minimize wear from contact with cups and optimize load transfer to cement, reducing stress shielding. Subject device is a size 00 line extension to existing AMIStem-C product line, providing smaller stem length and neck offset. Implants replace damaged femoral head/neck to restore joint function and reduce pain.

Clinical Evidence

Bench testing only. No clinical data. Performance testing leveraged from predicate device includes neck fatigue testing (ISO 7206-4:2010), shaft fatigue testing (ISO 7206-6:2013), Range of Motion (ROM) evaluation, bacterial endotoxin testing (LAL and USP <151>), sterilization validation, and shelf-life testing.

Technological Characteristics

Material: High Nitrogen Stainless steel (ISO 5832-9). Design: Straight, triple-tapered, rectangular cross-section femoral stem. Surface: Mirror-polished neck and body. Connectivity: None. Sterilization: Validated. Software: None.

Indications for Use

Indicated for patients requiring total or partial hip arthroplasty (primary or revision) due to severely painful/disabled joints from arthritis, rheumatoid polyarthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, or failure of previous hip surgeries.

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

• Medacta Total Hip Prosthesis System AMIStem C & QUADRA C Short Neck (K103189)

Reference Devices

• AMIStem-P stems (K173794)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

January 9, 2020

## Re: K193433

Trade/Device Name: AMIStem-C 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: LZO, JDI Dated: December 10, 2019 Received: December 10, 2019

Dear Chris Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K193433

Device Name AMIStem-C

### Indications for Use (Describe)

The hip prosthesis AMStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia

· Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

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

| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

## 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 PRAStaff(@fda.hhs.gov

"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}------------------------------------------------

# 3.0 510(k) Summary

#### I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone]

Contact Person: Stefano Baj, Regulatory Affairs and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: December 10, 2019 Date Revised: January 3, 2020

#### II. Device

| Device Proprietary Name: | AMIStem-C |
|--------------------------|-------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Femoral Stem |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,<br>Cemented or Non-Porous, Uncemented |
| Primary Product Code: | LZO |
| Secondary Product Codes: | JDI |
| Regulation Number: | 21 CFR 888.3353 |
| Device Classification | II |

#### III. Predicate Device

Substantial equivalence is claimed to the following device:

- Medacta Total Hip Prosthesis System AMIStem C & QUADRA C Short Neck, ● K103189, Medacta International SA
The following device is referenced in the submission: AMIStem-P stems ● K173794, Medacta International

#### IV. Device Description

AMIStem-C is a straight triple tapered cemented femoral stem of rectangular cross-section, for use in total or partial hip arthroplasty for primary or revision surgery. The material is High Nitrogen Stainless steel in accordance with ISO 5832-9.

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

Its superficial feature is a mirror polishing on the neck and the body: the whole body is mirror polished in order to minimize the wear due to the occasional contact between neck and cup, particularly in case of double-mobility cups, and to optimize the load transfer from stem to cement avoiding the stress shielding.

The AMIStem-C femoral stem size 00 is a line extension to the stems to the currently marketed Amistem-C product line.

#### V. Indications for Use

The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement is indicated in the following cases:

- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head ●
- Acute traumatic fracture of the femoral head or neck
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial ● hip arthroplasty, hip resurfacing replacement or total hip arthroplasty

#### VI. Comparison of Technological Characteristics

The subject AMIStem-C femoral stem and the predicate AMIStem-C femoral stems are identical with respect to materials of construction, surface finish, biocompatibility, device usage, sterility, shelf-life, and packaging.

The subject AMIStem-C femoral stem provides a smaller stem length and neck offset than the currently available AMIStem-C femoral stems. These differences do not introduce a new worst case from a clinical point of view or with respect to the biomechanical performance of the implants.

#### VII. Performance Data

The introduction of the AMIStem-C size 00 standard femoral stem does not create a new worst case; therefore, the following performance testing from the predicate device was leveraged to support this submission:

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

- neck fatigue testing per ISO 7206-4:2010; ●
- shaft fatigue testing per ISO 7206-6:2013; ●
- Range of Motion (ROM) Evaluation ●
- Bacterial Endotoxin Testing (LAL test and USP <151>); .
- sterilization validation; and ●
- shelf-life testing. .

## VIII. Conclusion

The information provided within this submission supports that the AMIStem C size 00 standard femoral stem is as safe and effective as the predicate device; therefore, the AMIStem-C is substantially equivalent to the predicate device.