Who is the manufacturer of Avenir Muller Stem, Avenir Cemented Hip Stem?

Zimmer GmbH filed the 510(k) submission for Avenir Muller Stem, Avenir Cemented Hip Stem (K193030).

What is the FDA product code for Avenir Muller Stem, Avenir Cemented Hip Stem?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Avenir Muller Stem, Avenir Cemented Hip Stem?

510(k) clearance (submission type: Special).

What are the predicate devices for Avenir Muller Stem, Avenir Cemented Hip Stem?

Avenir® Müller Stem (K123392).

Who can help prepare an FDA 510(k) submission like Avenir Muller Stem, Avenir Cemented Hip Stem?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Avenir Muller Stem, Avenir Cemented Hip Stem

K193030 · Zimmer GmbH · LZO · Dec 6, 2019 · Orthopedic

Device Facts

Record ID	K193030
Device Name	Avenir Muller Stem, Avenir Cemented Hip Stem
Applicant	Zimmer GmbH
Product Code	LZO · Orthopedic
Decision Date	Dec 6, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Avenir® Müller Stem is intended for: Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists. Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Acute traumatic fracture of the femoral head or neck. Avascular necrosis of the femoral head. Avenir® Müller Stems are for cementless use only. The Avenir® Cemented Hip Stem 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 Müller Stem and Avenir Cemented Hip Stem are femoral hip prostheses designed to replace the proximal femur in total or hemi-hip arthroplasty. Müller Stem is a wedge-shaped, collarless titanium alloy implant with proximal ribs and Ti-6Al-4V plasma spray/hydroxyapatite coating for cementless fixation. Cemented Hip Stem is a highly polished, wedge-shaped, collarless stainless steel alloy implant for cemented fixation. Both feature a 3D proximal-to-distal taper and are available in standard and lateralized versions. Used in clinical settings by orthopedic surgeons to restore hip function. Output is the physical replacement of the femoral head/neck, providing structural support and stability to the hip joint. Benefits include pain relief and improved mobility for patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence is supported by non-clinical performance testing, including packaging integrity verification per ISO 11607-1:2006 and ISO 11607-2:2006, and mechanical integrity/resistance testing for reclassified instruments.

Technological Characteristics

Avenir Müller Stem: Ti-6Al-4V titanium alloy with plasma spray and hydroxyapatite coating. Avenir Cemented Hip Stem: Stainless steel alloy. Both are wedge-shaped, collarless, single-unit femoral stems with 3D proximal-to-distal taper. Sterilization via validated methods. No software or electronic components.

Indications for Use

Indicated for patients with advanced joint wear due to degenerative, post-traumatic, or rheumatic diseases; failed previous hip surgery (osteotomy, arthrodesis, hemiarthroplasty, or THR); acute traumatic femoral head/neck fracture; or avascular necrosis of the femoral head. Avenir Müller Stem is for cementless use; Avenir Cemented Hip Stem is for cemented use.

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

Avenir® Müller Stem (K123392)

Reference Devices

Avenir® Cemented Hip Stem (K131884)
Avenir Complete Hip System (K182048)

Related Devices

K131884 — AVENIR CEMENTED HIP STEM · Zimmer GmbH · Aug 22, 2013
K123392 — AVENIR MULLER STEM · Zimmer GmbH · Mar 4, 2013
K173794 — AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared · Medacta International S.A. · Mar 14, 2018
K182048 — Avenir Complete Hip System · Zimmer, Inc. · Dec 7, 2018
K192189 — Avenir Complete Hip System, Size 0 Coxa Vara · Zimmer, Inc. · Dec 18, 2019

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). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 6, 2019 Zimmer GmbH Melanie Mitrov Regulatory Affairs, Specialist Sulzerallee 8 Winterthur, 8404 Switzerland Re: K193030 Trade/Device Name: Avenir Muller Stem, 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, KWY, KWZ, LWJ, MEH, KWL Dated: October 24, 2019 Received: October 30, 2019 Dear Melanie Mitrov: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K193030 Device Name Avenir® Müller Stem Indications for Use (Describe) · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. · Failed previous hip surgery (not THA) where pain, deformity, or dysfunction persists. · Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. · Acute traumatic fracture of the femoral head or neck. · Avascular necrosis of the femoral head. Avenir® Müller Stems are for cementless use only. 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) #### 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) #### K193030 Device Name Avenir® Cemented Hip Stem Indications for Use (Describe) 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, or total hip replacement (THR) - · Acute traumatic fracture of the femoral head or neck - Avascular necrosis of the femoral head. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;">☒Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## |X | Prescription Use (Part 21 CFR 801 Subpart D) #### 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a white "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color and is aligned to the right of the circle. # 510(k) Summary | Sponsor: | Zimmer GmbH Sulzerallee 8, P.O. Box 8404 Winterthur, Switzerland | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Melanie Mitrov Specialist, Regulatory Affairs Telephone: +41 58 854 233 Fax: +41 58 854 233 | | Date: | November 20, 2019 | | Trade Name: | Avenir® Müller Stem Avenir® Cemented Hip Stem | | Common Name | Femoral Stem | | Classification Product Code : | LZO, KWY, KWZ, LWJ, MEH, KWL | | Device Classification Name: | prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented prosthesis, hip, constrained, cemented or uncemented, metal/polymer prosthesis, hip, semi-constrained, metal/polymer, uncemented prosthesis, hip, semi-constrained, uncemented, metal / polymer, non- porous, calcium phosphate prosthesis, hip, hemi-, femoral, metal | | Regulation Number / Description: | 21 CFR § 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. 21 CFR § 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. 21 CFR § 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis. 21 CFR § 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. 21 CFR § 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. 21 CFR § 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. | | Primary Predicate Device: | Avenir® Müller Stem, manufactured by Zimmer GmbH, K123392, cleared March 2013 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the words "ZIMMER BIOMET" in a sans-serif font. The logo is simple and modern, and the blue and white color scheme is clean and professional. | Reference Device: | Subject Device | Reference Device | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Avenir® Cemented Hip Stem (K193030) only. | Avenir® Cemented Hip Stem, manufactured by Zimmer GmbH, K131884, cleared August 2013. | | Device Description: | The Avenir® Müller Stem is a titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit and the stem features proximal ribs on the anterior and posterior surfaces which are designed to increase stability. Except for the polished neck area, the surface of the stem is coated with Ti-6Al-4V titanium alloy plasma spray and oversprayed by a hydroxyapatite coating. The stem is available as both a lateralized and standard version. The Avenir® Cemented Hip Stem is a stainless steel alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design and features a three dimensional proximal-to-distal taper. The stem and neck are a single unit. The stem is highly polished and available as both a lateralized and standard version. | | | Intended Use | Avenir® Müller Stem is intended for: Advanced wear of the joint due to degenerative, post- traumatic or rheumatic diseases.Failed previous hip surgery (not THA) where pain, deformity or dysfunction persists.Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.Acute traumatic fracture of the femoral head or neck.Avascular necrosis of the femoral head. Avenir® Müller Stems are for cementless use only. | The Avenir® Cemented Hip Stem 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 diseasesFailed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR)Acute traumatic fracture of the femoral head or neckAvascular necrosis of the femoral head. | | Comparison to Predicate Device: | The intended use of the modified devices, as described in its labeling has not changed as a result of the modifications proposed in the | | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color, providing a contrast against the white background. | | present submission. Zimmer GmbH proposes modification of the indications for use thereby limiting the indications within those of the previously cleared devices. Modification of the packaging configuration for the subject implant devices is proposed. The new packaging configuration and the methods to support the package integrity have been previously described in K182048 (Avenir Complete Hip System). The proposed changes do not alter the fundamental scientific technology shared by both the subject devices and predicate device. Zimmer GmbH is furthermore seeking clearance for certain system-specific Class II instruments these instruments that have previously considered Class I exempt and correction of classification to Class II is proposed within present submission. | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: Packaging configuration change: Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Packaging Configuration testing was conducted by representative worst-case products. Correction of instrument classification from Class I to Class II: Amendment of Design Controls with verification of mechanical integrity and resistance. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. | | Conclusion: | The subject devices have the same intended use and similar indications for use as the predicate device. The subject devices use the same operating principle, incorporate the same basic design and labelling and are manufactured and sterilized using the same materials and processes as the predicate device. Except for the modifications described in this submission the subject devices are identical to the predicate device, and the performance data and analyses demonstrate that: <ul><li>any differences do not raise new questions of safety and effectiveness as established with performance testing; and </li><li>the subject devices are at least as safe and effective as the legally marketed predicate device </li></ul> | - legally marketed predicate device.