K Number

Device Name

PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS

Manufacturer

MICROPORT ORTHOPEDICS INC.

Date Cleared

2014-09-12

(122 days)

Product Code

LZO JDI LPH MBL

Regulation Number

888.3353

Intended Use

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - inflammatory degenerative joint disease such as rheumatoid arthritis; 2. - 3. correction of functional deformity; and, - 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

Device Description

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are available in 32 configurations and are coated with titanium plasma spray conforming to ASTM F1580. The 32 configurations consist of standard and reduced flare components (14 sizes reduced and 18 sizes standard). The reduced and standard flares refer to the amount of material in the proximal-medial region. Each flare configuration is available in two neck offset options, Straight (standard) and Varus 8° (extended). The geometry, distal-from-resection, is identical to those available with the predicate device.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K130984

Reference Devices

K130984

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical hip stem and its material properties and testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes

The device is a hip stem used in total hip arthroplasty to reduce pain and improve hip function, addressing conditions like degenerative joint disease and functional deformities.

Diagnostic

No
The description indicates the device is a hip stem used in total hip arthroplasty to reduce pain and improve hip function; it is a prosthetic implant, not a device used for diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a monolithic stem manufactured from forged titanium alloy, indicating it is a physical implant, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty. This is a medical device used in vivo (within the body) to replace a joint.
Device Description: The description details a physical implant made of titanium alloy, designed to be surgically implanted.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

Product codes

LZO, LPH, MBL, JDI

Device Description

The purpose of this submission is to provide a long neck option to the predicate PROFEMUR® Renaissance Classic Hip Stems (K130984) by adding a line extension. The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are available in 32 configurations and are coated with titanium plasma spray conforming to ASTM F1580. The 32 configurations consist of standard and reduced flare components (14 sizes reduced and 18 sizes standard). The reduced and standard flares refer to the amount of material in the proximal-medial region. Each flare configuration is available in two neck offset options, Straight (standard) and Varus 8° (extended). The geometry, distal-from-resection, is identical to those available with the predicate device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip

Indicated Patient Age Range

Skeletally mature patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Testing: The PROFEMUR® Renaissance® Classic Long Neck Hip Stems were evaluated by proximal and distal fatigue tests in accordance with ISO 7206-4 and 6 and satisfied the acceptance criteria of each. Additionally, the PROFEMUR® Renaissance® Classic Long Neck Hip Stems were evaluated for range of motion and were deemed acceptable per ISO 21535.
Clinical Testing: Clinical data was not provided for the subject devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K130984

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
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.(b)
Classification. Class II.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.

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

September 12, 2014

MicroPort Orthopedics, Inc. Mr. Byron Ledbetter Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

Re: K141235

Trade/Device Name: PROFEMUR® Renaissance® Classic Long Neck Hip Stems 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, LPH, MBL, JDI Dated: August 12, 2014 Received: August 13, 2014

Dear Mr. Ledbetter:

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

Page 2 - Mr. Byron Ledbetter

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

	Food and Duug Aministration	STORES MAMUH QUA HTJAH OF THEMITSAAD	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -	Date: Date: Jann	om Approved: OM	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Section 203(k) Mortgage Insurance: HUD's primary program for facilitating the rehabilitation and repair of single family properties. It insures mortgages that cover the purchase or refinancing of a home, and the cost of its rehabilitation. Section 203(k) mortgages are available to eligible borrowers through FHA-approved lending institutions nationwide. The minimum mortgage amount is $5,000.00. The maximum mortgage amount is determined by the FHA mortgage limits for the area. The borrower must meet standard FHA credit requirements to qualify for a Section 203(k) mortgage. The property must meet certain requirements to be eligible for a Section 203(k) mortgage. The property must be at least one year old. The property must be structurally sound and capable of being rehabilitated. The property must meet all applicable local codes and zoning requirements. The property must be the borrower's primary residence. Section 203(k) mortgages can be used for a variety of rehabilitation projects, including: Repairing or replacing roofs, Repairing or replacing windows and doors, Repairing or replacing siding, Repairing or replacing plumbing, Repairing or replacing electrical systems, Repairing or replacing heating and cooling systems, Repairing or replacing flooring, Painting, Installing new kitchens or bathrooms, Adding additions to the home, Making the home accessible to people with disabilities, Energy conservation improvements. Section 203(k) mortgages are a valuable tool for homeowners who want to rehabilitate or repair their homes. They can provide access to financing that would otherwise be unavailable. Section 203(k) mortgages can also help to improve the quality of housing in communities across the country. Section 203(k) Consultant: A professional who is trained and experienced in the rehabilitation of homes. Section 203(k) consultants can help borrowers to develop a rehabilitation plan, obtain bids from contractors, and oversee the rehabilitation process. Section 203(k) consultants are required for all Section 203(k) mortgages over $35,000.00. Section 203(k) consultants must be approved by HUD. Section 203(k) consultants can provide valuable assistance to borrowers who are undertaking a rehabilitation project. They can help to ensure that the project is completed on time and within budget. Section 203(k) consultants can also help to protect borrowers from fraud and abuse. Section 203(k) Streamline: A simplified version of the Section 203(k) program that is available for smaller rehabilitation projects. Section 203(k) Streamline mortgages are available for projects that cost less than $35,000.00. Section 203(k) Streamline mortgages do not require the use of a Section 203(k) consultant. Section 203(k) Streamline mortgages are a good option for borrowers who want to make minor repairs or improvements to their homes. Section 203(k) Limited Repair Program: A program that allows borrowers to finance up to $35,000.00 in repairs to their homes. Section 203(k) Limited Repair Program mortgages are available to eligible borrowers through FHA-approved lending institutions nationwide. The borrower must meet standard FHA credit requirements to qualify for a Section 203(k) Limited Repair Program mortgage. The property must meet certain requirements to be eligible for a Section 203(k) Limited Repair Program mortgage. The property must be at least one year old. The property must be structurally sound and capable of being rehabilitated. The property must meet all applicable local codes and zoning requirements. The property must be the borrower's primary residence. Section 203(k) Limited Repair Program mortgages can be used for a variety of rehabilitation projects, including: Repairing or replacing roofs, Repairing or replacing windows and doors, Repairing or replacing siding, Repairing or replacing plumbing, Repairing or replacing electrical systems, Repairing or replacing heating and cooling systems, Repairing or replacing flooring, Painting, Installing new kitchens or bathrooms, Making the home accessible to people with disabilities, Energy conservation improvements. Section 203(k) Limited Repair Program mortgages are a valuable tool for homeowners who want to rehabilitate or repair their homes. They can provide access to financing that would otherwise be unavailable. Section 203(k) Limited Repair Program mortgages can also help to improve the quality of housing in communities across the country. Section 203(k) Full: A more comprehensive version of the Section 203(k) program that is available for larger rehabilitation projects. Section 203(k) Full mortgages are available for projects that cost more than $35,000.00. Section 203(k) Full mortgages require the use of a Section 203(k) consultant. Section 203(k) Full mortgages are a good option for borrowers who want to make major repairs or improvements to their homes. Section 203(k) Supplemental Loan: A loan that can be used to finance additional repairs or improvements to a home that is already being rehabilitated under a Section 203(k) mortgage. Section 203(k) Supplemental Loans are available to eligible borrowers through FHA-approved lending institutions nationwide. The borrower must meet standard FHA credit requirements to qualify for a Section 203(k) Supplemental Loan. The property must meet certain requirements to be eligible for a Section 203(k) Supplemental Loan. The property must be at least one year old. The property must be structurally sound and capable of being rehabilitated. The property must meet all applicable local codes and zoning requirements. The property must be the borrower's primary residence. Section 203(k) Supplemental Loans can be used for a variety of rehabilitation projects, including: Repairing or replacing roofs, Repairing or replacing windows and doors, Repairing or replacing siding, Repairing or replacing plumbing, Repairing or replacing electrical systems, Repairing or replacing heating and cooling systems, Repairing or replacing flooring, Painting, Installing new kitchens or bathrooms, Making the home accessible to people with disabilities, Energy conservation improvements. Section 203(k) Supplemental Loans are a valuable tool for homeowners who want to rehabilitate or repair their homes. They can provide access to financing that would otherwise be unavailable. Section 203(k) Supplemental Loans can also help to improve the quality of housing in communities across the country. Section 203(k) Consultant Fees: The fees charged by Section 203(k) consultants for their services. Section 203(k) consultant fees are typically based on the scope of the rehabilitation project. Section 203(k) consultant fees can be financed as part of the Section 203(k) mortgage. Section 203(k) consultant fees are a necessary expense for borrowers who are undertaking a rehabilitation project. They can help to ensure that the project is completed on time and within budget. Section 203(k) consultant fees can also help to protect borrowers from fraud and abuse. Section 203(k) Contingency Reserve: A reserve of funds that is set aside to cover unexpected costs that may arise during the rehabilitation project. Section 203(k) contingency reserves are typically 10-20% of the total cost of the rehabilitation project. Section 203(k) contingency reserves can be financed as part of the Section 203(k) mortgage. Section 203(k) contingency reserves are a necessary precaution for borrowers who are undertaking a rehabilitation project. They can help to protect borrowers from financial hardship if unexpected costs arise. Section 203(k) Draw Request: A request for funds from the Section 203(k) mortgage to pay for work that has been completed on the rehabilitation project. Section 203(k) draw requests must be approved by the lender and the Section 203(k) consultant. Section 203(k) draw requests are typically paid directly to the contractor. Section 203(k) draw requests are a necessary part of the Section 203(k) process. They help to ensure that the contractor is paid for their work and that the rehabilitation project is completed on time and within budget. Section 203(k) Final Inspection: An inspection that is conducted by the lender and the Section 203(k) consultant to ensure that the rehabilitation project has been completed in accordance with the rehabilitation plan. Section 203(k) final inspections are required before the final draw request can be approved. Section 203(k) final inspections are a necessary part of the Section 203(k) process. They help to ensure that the rehabilitation project has been completed to the borrower's satisfaction and that the property meets all applicable codes and zoning requirements. Section 203(k) Completion Certificate: A certificate that is issued by the lender and the Section 203(k) consultant after the final inspection has been completed and the rehabilitation project has been approved. Section 203(k) completion certificates are required before the Section 203(k) mortgage can be converted to a permanent mortgage. Section 203(k) completion certificates are a necessary part of the Section 203(k) process. They help to ensure that the rehabilitation project has been completed to the borrower's satisfaction and that the property meets all applicable codes and zoning requirements. Section 203(k) Conversion to Permanent Mortgage: The process of converting the Section 203(k) mortgage to a permanent mortgage after the rehabilitation project has been completed. Section 203(k) conversion to permanent mortgage is typically done after the Section 203(k) completion certificate has been issued. Section 203(k) conversion to permanent mortgage is a necessary part of the Section 203(k) process. It allows the borrower to lock in a fixed interest rate and monthly payment for the remainder of the mortgage term. Section 203(k) Default: The failure to make payments on the Section 203(k) mortgage. Section 203(k) default can lead to foreclosure. Section 203(k) default is a serious problem that can have a devastating impact on borrowers and their families. Section 203(k) Foreclosure: The process of taking possession of a property after the borrower has defaulted on the Section 203(k) mortgage. Section 203(k) foreclosure can result in the borrower losing their home. Section 203(k) foreclosure is a serious problem that can have a devastating impact on borrowers and their families. Section 203(k) Loss Mitigation: The process of working with borrowers who are at risk of defaulting on their Section 203(k) mortgage to help them avoid foreclosure. Section 203(k) loss mitigation can include options such as forbearance, loan modification, and short sale. Section 203(k) loss mitigation is a valuable tool for helping borrowers to stay in their homes. Section 203(k) Claims: Claims that are filed by lenders with HUD to recover losses that they have incurred as a result of Section 203(k) defaults. Section 203(k) claims are paid out of the FHA insurance fund. Section 203(k) claims are a necessary part of the Section 203(k) program. They help to protect lenders from losses and to ensure that the program remains financially sound. Section 203(k) Program Evaluation: An evaluation of the Section 203(k) program that is conducted by HUD to assess the program's effectiveness and to identify areas for improvement. Section 203(k) program evaluations are conducted on a regular basis. Section 203(k) program evaluations are a valuable tool for ensuring that the program is meeting its goals and that it is serving the needs of borrowers and communities across the country. Section 203(k) Program Regulations: The regulations that govern the Section 203(k) program. Section 203(k) program regulations are published in the Code of Federal Regulations (CFR). Section 203(k) program regulations are a valuable resource for borrowers, lenders, and other stakeholders who are involved in the Section 203(k) program. Section 203(k) Program Guidance: Guidance that is issued by HUD to help borrowers, lenders, and other stakeholders to understand and comply with the Section 203(k) program regulations. Section 203(k) program guidance is published in a variety of formats, including handbooks, mortgagee letters, and training materials. Section 203(k) program guidance is a valuable resource for anyone who is involved in the Section 203(k) program. Section 203(k) Program Training: Training that is provided by HUD to help borrowers, lenders, and other stakeholders to understand and comply with the Section 203(k) program regulations. Section 203(k) program training is offered in a variety of formats, including online courses, webinars, and in-person workshops. Section 203(k) program training is a valuable resource for anyone who is involved in the Section 203(k) program. Section 203(k) Program Resources: Resources that are available to help borrowers, lenders, and other stakeholders to learn more about the Section 203(k) program. Section 203(k) program resources include the HUD website, the FHA Resource Center, and the Section 203(k) Handbook. Section 203(k) program resources are a valuable tool for anyone who is interested in learning more about the Section 203(k) program. Section 203(k) Program Contact Information: Contact information for HUD staff who can answer questions about the Section 203(k) program. Section 203(k) program contact information is available on the HUD website. Section 203(k) program contact information is a valuable resource for anyone who has questions about the Section 203(k) program. Section 203(k) Program Success Stories: Stories of borrowers who have successfully used the Section 203(k) program to rehabilitate or repair their homes. Section 203(k) program success stories are available on the HUD website. Section 203(k) program success stories are a valuable tool for inspiring other borrowers to consider using the Section 203(k) program. Section 203(k) Program Challenges: Challenges that are faced by borrowers, lenders, and other stakeholders who are involved in the Section 203(k) program. Section 203(k) program challenges include the complexity of the program, the difficulty of finding qualified contractors, and the risk of fraud and abuse. Section 203(k) program challenges are important to be aware of so that borrowers, lenders, and other stakeholders can take steps to mitigate these risks. Section 203(k) Program Future: The future of the Section 203(k) program. The Section 203(k) program is expected to continue to be a valuable tool for homeowners who want to rehabilitate or repair their homes. The Section 203(k) program is also expected to continue to evolve to meet the changing needs of borrowers and communities across the country. Section 203(k) Program Conclusion: The Section 203(k) program is a valuable tool for homeowners who want to rehabilitate or repair their homes. The Section 203(k) program can provide access to financing that would otherwise be unavailable. The Section 203(k) program can also help to improve the quality of housing in communities across the country. Section 203(k) Program Disclaimer: The information contained in this document is for informational purposes only and does not constitute legal or financial advice. Borrowers should consult with a qualified professional before making any decisions about the Section 203(k) program. Section 203(k) Program Copyright: This document is copyrighted by HUD. All rights reserved. Section 203(k) Program Contact Information: HUD 451 7th Street SW Washington, DC 20410 (202) 708-1112

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See Premeters Statement ary 31, 2017 0210-0160 00020

ndications for Use

K141235

Device Name

tory, declarative, joint, dis-

Image /page/3/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with a white circle and a red star inside, followed by the words "MicroPort" in blue and "Orthopedics" in red. Below the logo, the words "MicroPort Orthopedics Inc." are written in black.

510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Renaissance® Classic Long Neck Hip Stems.

| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington, TN 38002
Phone: (866) 872-0211
Fax: (855) 446-2247 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 3, 2014 |
| Contact Person: | Byron Ledbetter
Regulatory Affairs Specialist II |
| Proprietary Name of Modified Device: | PROFEMUR® Renaissance® Classic Long
Neck Hip Stems |
| Common Name: | Femoral Hip Stem |
| Classification Name and Reference: | 888.3353 LZO
Hip joint metal/ceramic/polymer semi
constrained cemented or nonporous,
uncemented prosthesis
Class II |
| | 888.3350 JDI
Hip joint metal/polymer semi-constrained
cemented prosthesis
Class II |
| | 888.3358 LPH
Hip joint metal/polymer/metal semi-
Constrained porous-coated
uncemented prosthesis
Class II |

Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red four-pointed star. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Underneath the entire logo is the text "MicroPort Orthopedics Inc." in black.

888.3358 MBL Hip joint metal/polymer/metal semi-Constrained poruous-coated uncemented prosthesis Class II

Subject Product Code and Panel Code:

Orthopedics/87/LZO/JDI/LPH/MBL

Predicate Devices:

PROFEMUR® Renaissance® Classic Hip Stem, K130984

Device Description

Intended Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
1. correction of functional deformity; and,
1. revision procedures where other treatments or devices have failed.

Image /page/5/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red underneath. Below the logo is the text "MicroPort Orthopedics Inc." in black.

Technological Characteristics of the Device

The indications for use of the PROFEMUR® Renaissance® Classic Long Neck Hip Stems are identical to those for the predicate device (K130984). The subject devices are made from an identical titanium alloy (ASTM F620) and possess an identical titanium plasma spray coating (ASTM 1580) as the predicate device. The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are designed to provide geometry, distal-from-resection, which is identical to those available with the predicate device with the exception of neck length.

Nonclinical Testing

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems were evaluated by proximal and distal fatigue tests in accordance with ISO 7206-4 and 6 and satisfied the acceptance criteria of each. Additionally, the PROFEMUR® Renaissance® Classic Long Neck Hip Stems were evaluated for range of motion and were deemed acceptable per ISO 21535.

Clinical Testing

Clinical data was not provided for the subject devices.

Conclusions

The indications for use and fundamental scientific technology of the PROFEMUR® Renaissance" Classic Long Neck Hip Stems are identical to those of the predicate device. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The safety and effectiveness of the PROFEMUR® Renaissance® Classic Long Neck Hip Stems is adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.