(86 days)
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No
The document describes a mechanical device (distal centralizers) made of PMMA for use in hip arthroplasty. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No
The device is a component used in total hip arthroplasty to guide the implant and center the hip stem, not a therapeutic device itself that directly treats pain or improves function. Its role is mechanical and supportive within the surgical procedure.
No
The device is a PMMA centralizer used in total hip arthroplasty to guide the hip stem implant and create a uniform cement mantle. Its intended use is for treatment and surgical assistance, not for diagnosing a condition.
No
The device is a physical component (molded PMMA centralizers) intended for surgical implantation, not a software program.
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 device used in vivo (within the body) during a surgical procedure (total hip arthroplasty) to aid in the placement of a hip stem implant. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical component (molded PMMA centralizer) placed within the femoral canal. This is consistent with a surgical implant accessory, not a diagnostic test performed on a biological sample.
- Anatomical Site: The device is used in the "femoral canal," which is an internal anatomical location. IVDs typically interact with biological samples like blood, urine, tissue, etc., outside the body.
The information provided aligns with a medical device used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The PMMA Distal Centralizers 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,
-
- revision procedures where other treatments or devices have failed
The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.
Product codes
LZO, JDI
Device Description
The PROFEMUR® X™ Distal Centralizers are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The material used for the Distal Centralizers identically conforms to the same material standard as the predicate devices (molded PMMA), but will use a new material resin. Like the predicate, the replacement resin will contain 2 copolymers, designed to contribute to material properties.
The worst case design of the subject material for the PROFEMUR® X™ Centralizers was evaluated via functional testing, chemical analysis and biocompatibility. A review of these that the PROFEMUR® X" Centralizers are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femoral canal, hip
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The PROFEMUR® X" Distal Centralizers have been tested by functional and biocompatibility testing, and chemical analysis. A review of the results indicates that the PROFEMUR® X™ Centralizers are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 1 9 2013
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® X™ Distal Centralizers.
Submitted By:
.
.
.
.
Date:
Contact Person:
5677 Airline Rd, Arlington TN, 38002 (800) 238-7188
Wright Medical Technology, Inc.
January 22, 2013
Matt Paul Regulatory Affairs
Proprietary Name:
Common Name:
Classification Name and Reference:
Subject Product Code and Panel Code:
Predicate Devices Name and Number:
PROFEMUR® X™ Distal Centralizers
Centralizer
21 CFR 888. 3353 LZO Hip joint metal/ceramic/ polymer, cemented or non-porous, uncemented prosthesis Class II
Orthopedics/87/ LZO, JDI
PROFEMUR® X™ (PROFEMUR XTR)
510(k): K052915
Predicate Classification and Number:
Orthopedics/87/ LZO, 888.3353
DEVICE INFORMATION
A. Device Description
The PROFEMUR® X™ Distal Centralizers are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The material used for the Distal Centralizers identically conforms to the same material standard as the predicate devices (molded PMMA), but will use a new material resin. Like the predicate, the replacement resin will contain 2 copolymers, designed to contribute to material properties.
The worst case design of the subject material for the PROFEMUR® X™ Centralizers was evaluated via functional testing, chemical analysis and biocompatibility. A review of these that the PROFEMUR® X" Centralizers are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.
1
B. Intended Use
·
Wright Distal Centralizers are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
-
- revision procedures where other treatments or devices have failed
Wright Distal Centralizers are indicated for cemented hip arthroplasty.
C. Technological Characteristics of the Device
The PROFEMUR® X™ Distal Centralizers have the same technological characteristics as the predicate devices. The PMMA Distal Centralizers are placed on the hip stem implant during its final insertion into the bone, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within the femoral canal, and thereby allow a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The material used for the Distal Centralizers identically conforms to ASTM F451 as does the material used for the predicate devices (molded PMMA).
D. Nonclinical Testing
The PROFEMUR® X" Distal Centralizers have been tested by functional and biocompatibility testing, and chemical analysis. A review of the results indicates that the PROFEMUR® X™ Centralizers are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure.
ن Clinical Testing
Clinical data was not provided for the centralizers.
ﻨﺎ Conclusions
The indications for use of the PROFEMUR® X™ Distal Centralizers are identical to the previously cleared predicate devices. The design features and processing of the devices are unchanged. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® X™ Distal Centralizers are adequately supported by the substantial equivalence information, materials information, and analysis data summarized within this Premarket Notification.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 19, 2013
Wright Medical Technology. Incorporated % Mr. Matt Paul Project Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002
Re: K130167
Trade/Device Name: PROFEMUR® X™ Distal Centralizers 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 Dated: February 28, 2013 Received: March 1, 2013
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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Matt Paul
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 (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 Small Manufacturers, International and Consumer Assistance 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.
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
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K130167
Indications for Use
Device Name: PROFEMUR® X™ Distal Centralizers
Indications For Use:
The PMMA Distal Centralizers 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;
- ന് correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.
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)
Elizabet កើរ
Division of Orthopedic Devices