(89 days)
PROFEMUR® Preserve Hip Stems, K112080
No
The summary describes a hip stem implant and its mechanical testing, with no mention of AI or ML technology.
Yes
The device is a hip stem used in total hip arthroplasty to reduce pain and improve hip function, indicating a therapeutic purpose.
No
The PROFEMUR® Preserve Hip Stems are described as components for total hip arthroplasty, intended for treatment of conditions like degenerative joint disease and functional deformity. Their testing involves fatigue tests and range of motion evaluation, not diagnostic measurements or interpretation.
No
The device description clearly states the device is a physical hip stem manufactured from titanium alloy, which is a hardware component.
Based on the provided text, 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, addressing conditions like osteoarthritis and rheumatoid arthritis. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a modular hip stem made from titanium alloy, designed for surgical implantation.
- 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.
N/A
Intended Use / Indications for Use
The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended 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;
- 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;
- correction of functional deformity; and,
4, revision procedures where other treatments or devices have failed
The PROFEMUR® Preserve Sizes 1-3 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, JDI, LPH, MBL
Device Description
The PROFEMUR® Preserve Sizes 1-3 Hip Stems are modular stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are available in three configurations and are coated with titanium plasma spray conforming to ASTM F1580.
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
Nonclinical Testing:
The PROFEMUR® Preserve Sizes 1-3 Hip Stems were evaluated by proximal and distal fatigue tests in accordance with ISO 7206-4 and ASTM F2068. The devices satisfied the acceptance criteria of each standard.
Range of motion was evaluated and satisfied the acceptance criteria of ISO 21535.
Clinical Testing: Clinical data was not provided for the subject devices.
Key Metrics
Not Found
Predicate Device(s)
PROFEMUR® Preserve Hip Stems, K112080
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, composed of three wavy lines forming a profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
MicroPort Orthopedics, Incorporated Mr. Byron Ledbetter Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K150133
Trade/Device Name: PROFEMUR® Preserve Sizes 1-3 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, JDI, LPH, MBL Dated: December 23, 2014 Received: January 21, 2015
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
1
(21 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 (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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K150133 (pg 1/1)
Device Name PROFEMUR® Preserve Sizes 1-3 Hip Stems
Indications for Use (Describe)
The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended 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;
-
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;
-
correction of functional deformity; and,
4, revision procedures where other treatments or devices have failed
The PROFEMUR® Preserve Sizes 1-3 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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PROFEMUR® Preserve Sizes 1-3 Hip Stems Traditional 510(k) 510(k) Summary
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: | December 23, 2014 |
| Contact Person: | Byron Ledbetter
Regulatory Affairs Specialist II |
| Proprietary Name of Modified Device: | PROFEMUR® Preserve Sizes 1-3 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 |
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Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with a white circle inside, and a red diamond shape in the center of the circle. 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.
PROFEMUR® Preserve Sizes 1-3 Hip Stems Traditional 510(k) 510(k) Summary
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
888.3358 MBL Hip joint metal/polymer/metal semi-Constrained poruous-coated uncemented prosthesis Class II
Subject Product Code and Panel Code:
Predicate Devices:
PROFEMUR® Preserve Hip Stems, K112080
Orthopedics/87/LZO/JDI/LPH/MBL
Device Description
The purpose of this submission is to provide additional sizing options for the predicate PROFEMUR® Preserve Hip Stems (K112080) by adding a line extension. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are modular stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are available in three configurations and are coated with titanium plasma spray conforming to ASTM F1580.
Intended Use
The PROFEMUR® Preserve Sizes 1-3 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:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed.
The PROFEMUR® Preserve Sizes 1-3 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.
5
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 word "MicroPort" in a large, bold, blue font, with the word "Orthopedics" in a smaller, red font underneath it. Below the logo is the text "MicroPort Orthopedics Inc." in a smaller, black font.
Technological Characteristics of the Device
The indications for use of the PROFEMUR® Preserve Sizes 1-3 Hip Stems are identical to those for the predicate device (K112080). 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® Preserve Sizes 1-3 Hip Stems are designed to provide geometry which is similar to those available with the predicate device.
Nonclinical Testing
The PROFEMUR® Preserve Sizes 1-3 Hip Stems were evaluated by proximal and distal fatigue tests in accordance with ISO 7206-4 and ASTM F2068. The devices satisfied the acceptance criteria of each standard.
Range of motion was evaluated and satisfied the acceptance criteria of 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® Preserve Sizes 1-3 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® Preserve Sizes 1-3 Hip Stems is adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.