(63 days)
No
The device description and performance studies focus on the material properties, mechanical testing, and design features of a hip stem, with no mention of AI or ML.
Yes
The device is a prosthesis intended to replace a diseased or damaged hip joint and restore function, thereby providing a therapeutic benefit for conditions like osteoarthritis or avascular necrosis.
No.
The device is a PROFEUR® Preserve Classic Stem, which is a femoral component used in total hip arthroplasty to reduce or relieve pain and improve hip function. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is a monolithic femoral component manufactured from forged titanium alloy, indicating it is a physical implant, not software.
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 to treat conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (femoral stem) made of titanium alloy, designed for surgical implantation. This is consistent with a medical device, not an IVD.
- Performance Studies: The performance studies focus on mechanical properties like range of motion and fatigue testing, which are relevant to the structural integrity and function of a surgical implant. IVD performance studies would involve evaluating the accuracy and reliability of a test to detect a substance or condition.
- Anatomical Site: The anatomical site is the hip joint, which is where the device is surgically implanted. IVDs typically analyze biological samples (blood, urine, tissue, etc.) collected from the body.
In summary, the PROFEMUR® Preserve Classic Stems are a surgical implant used in total hip arthroplasty, which falls under the category of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROFEMUR® Preserve Classic 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 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 Classic 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 (comma separated list FDA assigned to the subject device)
LZO
Device Description
The PROFEMUR® Preserve Classic Stems are monolithic femoral components manufactured from a forged titanium alloy (ASTM F620). The hip stems are designed for use in cementless total hip arthroplasty and possess identical indications for use to the predicates (K112080).
The design features of the PROFEMUR® Preserve Classic Stems are summarized below:
- Stems are forged from Ti6Al4V alloy conforming to ASTM F620
- Stems possess unalloyed titanium plasma coating manufactured from powder conforming to ASTM F1580
- Neck offsets are offered in Straight and Varus 8 options
- Stems are offered in twelve sizes for both neck offsets
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)
The subject PROFEMUR® Preserve Classic Stems were evaluated for range of motion in accordance with ISO 21535. The stems were also successfully evaluated by proximal fatigue testing according to ISO 7206-6. The subject stems were verified to be applicable to ISO 7206-4 distal fatigue testing that was performed on a modular stem possessing a similar geometry. The FEA models used in comparison were previously validated in testing submitted in K141235. Successful results of testing support the expectation that the device will perform as intended under normal physiological loading conditions, and support the substantial equivalence of the PROFEMUR® Preserve Classic Stem.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MicroPort Orthopedics. Incorporated Mr. Matt Paul Regulatory Affairs Project Manager 5677 Airline Road Arlington, Tennessee 38002
April 10, 2015
Re: K150302 Trade/Device Name: PROFEMUR® Preserve Classic 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 Dated: February 5, 2015 Received: February 6, 2015
Dear Mr. Paul:
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
Page 2 - Mr. Matt Paul
(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/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 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,
Mark N. Melkerson -S
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)
K150302 (page 1/1)
Device Name PROFEMUR® Preserve Classic Stem
Indications for Use (Describe)
The PROFEMUR® Preserve Classic 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 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 Classic 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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3
Image /page/3/Picture/1 description: The image shows the logo and contact information for MicroPort Orthopedics. The logo features the company name in blue text with a red star in a blue square. Below the logo is the company's address, which is 5677 Airline Road, Arlington, TN 38002, and their website, ortho.microport.com.
510(k) Summary of Safety and Effectiveness
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, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Preserve Classic Stems.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
Phone: 901-867-4350
Fax: 901-451-6018 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 5, 2015 |
| Contact Person: | Matt Paul
Requlatory Affairs Project Manager |
| Proprietary Name: | PROFEMUR® Preserve Classic Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 888.3353 LZO Hip joint metal/ceramic/polymer semi
constrained cemented or nonporous, uncemented prosthesis -
Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/ LZO |
| Predicate Device: | PROFEMUR® Preserve Stem (K112080) |
| Reference Devices: | DYNASTY® Biofoam Shell (K122382)
PROFEMUR® TL Classic Hip Stem (K123688)
PROFEMUR® TL Classic Long Neck Hip Stems (K140676) |
4
l. Device Description
The PROFEMUR® Preserve Classic Stems are monolithic femoral components manufactured from a forged titanium alloy (ASTM F620). The hip stems are designed for use in cementless total hip arthroplasty and possess identical indications for use to the predicates (K112080). The design features of the PROFEMUR® Preserve Classic Stems are summarized below:
- . Stems are forged from Ti6Al4V alloy conforming to ASTM F620
- Stems possess unalloyed titanium plasma coating manufactured from powder ● conforming to ASTM F1580
- . Neck offsets are offered in Straight and Varus 8 options
- Stems are offered in twelve sizes for both neck offsets ●
II. Indications for Use
Identically to the predicate, the PROFEMUR® Preserve Classic 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 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 Classic Stems are single use components, intended for use in uncemented total hip arthroplasty.
PROFEMUR® Preserve Classic is intended for use with the sterile compatible components listed in Table 1 below, identical to the predicate.
5
| Table 1. Compatible Components | ||
|---|---|---|
| 510(k) | Intended Combinations | |
| Modular Femoral Neck Sleeves | ||
| K072656 | Short to X-long neck sleeves to use with ceramic-polyethylene with ID 38-46mm | |
| Modular Femoral Heads | ||
| K953025 | Metal-Polyethylene, OD 28mm XXL | |
| K932222 | Metal-Polyethylene, OD 28mm | |
| K920593 | Ceramic-Polyethylene, OD 28mm | |
| K925512 | Ceramic-Polyethylene, OD 28mm | |
| K893685 | Ceramic-Polyethylene with ID 28-36mm | |
| K002149 | Metal-Polyethylene with ID 22-36mm, OD 42-68mm | |
| K051348 | Metal-Polyethylene with ID 36-56mm | |
| K072656 | Ceramic-Polyethylene with ID 38-46mm | |
| Acetabular Shell and Inserts | ||
| K002149 | Metal-Poly with ID 22-36mm, OD 42-68mm | |
| K043073 | Metal-Polyethylene and Ceramic-Polyethylene with ID 22-36mm, OD 46-68mm | |
| K043099 | Metal-Polyethylene and Ceramic-Polyethylene with ID 22-36mm, OD 46-68mm | |
| K052026 | Metal-Polyethylene and Ceramic-Polyethylene with ID 28-36mm | |
| K061547 | Metal-Polyethylene with ID 32-42mm, OD 50-58mm | |
| K070785 | Metal-Polyethylene and Ceramic-Polyethylene with ID 28-46mm, OD 46-68mm | |
| K082924 | Metal-Polyethylene with ID 28-54mm, OD 46-76mm | |
| K122382 | Metal-Polyethylene with OD 46-76 mm |
III. Nonclinical Testing
The subject PROFEMUR® Preserve Classic Stems were evaluated for range of motion in accordance with ISO 21535. The stems were also successfully evaluated by proximal fatigue testing according to ISO 7206-6. The subject stems were verified to be applicable to ISO 7206-4 distal fatigue testing that was performed on a modular stem possessing a similar geometry. The FEA models used in comparison were previously validated in testing submitted in K141235. Successful results of testing support the expectation that the device will perform as intended under normal physiological loading conditions, and support the substantial equivalence of the PROFEMUR® Preserve Classic Stem.
IV. Clinical Testing
Clinical data was not provided for the subject devices.
6
V. Technological Characteristics
The PROFEMUR® Preserve Classic Stems are designed to provide geometric sizing options that resemble a subset of those available with the predicate device. Furthermore, the subject devices are made from an identical titanium alloy (ASTM F620) and possess an identical titanium plasma spray coating design specification and material (ASTM F1580 powder) to the predicate device. Coating process and vendor information are identical to those provided for reference device K123688.
For all associated instruments that do contain colorants, detailed color additive information was provided for the same instruments in K140676.
VI. Substantial Equivalence Information
The intended use and indications for use of the PROFEMUR® Preserve Classic Stems are identical to those of the predicate devices (K112080). The materials of the subject devices are identical to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to that of the predicate devices. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. For more details on subject and predicate comparison, see the comparison table located in the Device Description (Tab 014).
VII. Conclusion
The design features, subject and predicate testing, materials information, and analysis data provided in this premarket notification adequately support the substantial equivalence of the PROFEMUR® Preserve Classic Stem.