AVENIR CEMENTED HIP STEM

K131884 · Zimmer GmbH · LZO · Aug 22, 2013 · Orthopedic

Device Facts

• Record ID: K131884
• Device Name: AVENIR CEMENTED HIP STEM
• Applicant: Zimmer GmbH
• Product Code: LZO · Orthopedic
• Decision Date: Aug 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of: - Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases - Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR) - Acute traumatic fracture of the femoral head or neck - Avascular necrosis of the femoral head.

Device Story

Avenir® Cemented Hip Stem is a femoral hip prosthesis designed for cemented fixation into the intramedullary canal. Device is a straight, double-tapered stem manufactured from Protasul-S30 stainless steel. Tapered geometry matches Avenir-Müller stem to promote self-locking within the femoral canal. Used by orthopedic surgeons in clinical settings for total or hemi hip arthroplasty. Provides structural replacement for damaged femoral components, facilitating joint rehabilitation and restoring hip function for patients with degenerative, traumatic, or necrotic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence established via non-clinical bench testing, including accelerated corrosion fatigue, proximal/mid-stem fatigue, pull-off strength, burst strength, and range of motion analysis.

Technological Characteristics

Material: Protasul-S30 stainless steel. Design: Straight, double-tapered femoral stem. Fixation: Cemented. Principle: Mechanical load-bearing prosthesis for hip arthroplasty. No software or electronic components.

Indications for Use

Indicated for patients requiring total or hemi hip arthroplasty due to degenerative, post-traumatic, or rheumatic joint wear; failed prior hip surgeries (osteotomy, arthrodesis, hemiarthroplasty, or THR); acute traumatic femoral head/neck fractures; or avascular necrosis of the femoral head.

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

• MS-30® Hip Prosthesis (K993043, K001078, K020713, K040803)
• Avenir® Müller Cementless Hip Stem (K123392)

Submission Summary (Full Text)

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Sponsor:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Names . and References:

Classification Panel:

Predicate Device(s):

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

## K131884

## 510(k) Summary

Zimmer, GmbH Sulzer Allee 8 Winterthur CH-8404 Switzerland

**AUG 2 2 2013**

Karen O'Leary Senior Specialist, Regulatory Affairs Telephone: [phone] Fax: [phone]

24 June 2013

Avenir® Cemented Hip Stem

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented

21 CFR §888.3353 - LZO - Prosthesis, hip, semiconstrained, metal/ceramic/polymer, cemented or non-porous, uncemented

21 CFR 8888.3360 - LWJ - Prosthesis, hip, semiconstrained, metal/polymer, uncemented

21 CFR \$888.3360 - KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis

21 CFR &88.3310 - KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer

21 CFR §888.3390 - KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Orthopedics/87

MS-30® Hip Prosthesis, manufactured by Zimmer GmbH,

- K993043, cleared December 2, 1999 .
- K001078, cleared June 23, 2000 ●
- K020713, cleared May 14, 2002 .
- K040803, cleared April 29, 2004 .

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## K131884

Avenir® Müller Cementless Hip Stem, manufactured by Zimmer GmbH

· K123392, cleared March 4, 2013

The Avenir Cemented Hip Stem is a femoral hip prosthesis that is designed for cemented fixation into the intramedullary canal for pathological or degenerative conditions involving the femur that merit total or hemi hip arthroplasty.

The Avenir Cemented Hip Stem is a straight, doubletapered stem manufactured from Protasul - S30 stainless steel material. The tapered aspects of the stem match the Avenir-Müller Stem, and promotes self-locking of the stem within the femoral canal.

The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

- Advanced wear of the joint due to degenerative, post-. traumatic, or rheumatic diseases
- Failed previous hip surgery including . joint reconstruction (osteotomy). arthrodesis, hemiarthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck .
- Avascular necrosis of the femoral head. .

The Avenir® Cemented Stem is similar in intended use, materials, sterility and performance characteristics to the predicate device(s).

Non-Clinical Performance and Conclusions:

The results of non-clinical (lab) performance testing demonstrate the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included: Accelerated Corrosion Fatigue Test, Proximal & Mid-Stem Fatigue Testing, Pull-off Strength testing and rationale, summary of Burst Strength Testing and Range of Motion analysis.

## Purpose and Device Description:

### Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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

August 22, 2013

Zimmer GmbH Ms. Karen O'Leary Senior Specialist, Regulatory Affairs Zimmer Incorporated P.O. Box 708 Warsaw, Indiana 46581

Re: K131884

Trade/Device Name: Avenir® Cemented Hip 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: LZO, LWJ, KWL, KWL, KWZ, KWY Dated: June 24, 2013 Received: June 25, 2013

Dear Ms. O'Leary:

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

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## Page 2 - Ms. Karen O'Leary

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

# Erin I. Keith

For

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

## 510(k) Number (if known): K131884

## Device Name:

Avenir® Cemented Hip Stem

### Indications for Use:

The product is intended for total or hemi hip arthroplasty with cemented applications for rehabilitating hips damaged as a result of:

- Advanced wear of the joint due to degenerative, post-traumatic, or rheumatic diseases ●
- Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, ● hemiarthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck ●
- Avascular necrosis of the femoral head. .

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

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Division of Orthopedic Devices

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