(90 days)
No
The document describes a mechanical implant (femoral stem) and its physical properties and testing. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is used to reduce or relieve pain and/or improve hip function, which are therapeutic goals.
No
This device, the PROFEMUR® Z Classic Stems, is a total hip arthroplasty component, which is a medical implant used to replace a joint, not to diagnose a condition. Its intended use is for reduction or relief of pain and/or improved hip function in patients with certain conditions, which are therapeutic rather than diagnostic purposes.
No
The device description clearly states it is a monolithic femoral stem manufactured from forged titanium alloy, which 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, addressing conditions like osteoarthritis and rheumatoid arthritis. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as a monolithic femoral stem manufactured 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, or tissue) to provide information for diagnosis, monitoring, or treatment.
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® Z 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® Z 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
LZO, JDI
Device Description
The purpose of this submission is to add a monolithic femoral neck option to the PROFEMUR® Z Hip System. The PROFEMUR® Z Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Z Classic Stems are available in 9 sizes (1-9) and are available in two surface finish options: gritblast or titanium plasma spray conforming to ASTM F1580. Each size is available with either a long or short fixed femoral neck and all sizes are available in two neck offset options, Standard (neutral) and Extended (varus). The surface finish options, neck lengths, and neck offset are designed to create options identical to those available with the predicate modular devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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
The PROFEMUR® Z Classic Stems were evaluated in proximal and distal fatigue tests in accordance with ISO 7206-4, 6, and 8 and satisfied the acceptance criteria of each. Range of motion was evaluated in accordance with ISO 21535 and the subject device satisfied the acceptance criteria. The titanium plasma spray coating is applied according to WMT specification and is identical to that used in the predicate device (K111699). The titanium plasma spray coating was verified by testing present within a vendor Master File and summarized within this premarket notification.
Key Metrics
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.
0
PROFEMUR® Z Classic Stems Special 510(k) 510(k) Summary
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized design consisting of three horizontal, overlapping shapes that resemble stylized wings or arrows. The shapes are black and create a sense of movement or direction.
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® Z Classic Stems.
(a)(1) Submitted By:
Date:
Contact Person:
(a)(2) Proprietary Name of Modified Device:
Common Name:
Classification Name and Reference:
Subject Product Code and Panel Code:
(a)(3) Predicate Devices:
Wright Medical Technology, Inc. 5677 Airline Rd Arlington, TN 38002 (800) 238-7188
November 5, 2012
David Fitch, PhD Clinical Affairs Specialist
· PROFEMUR® Z Classic Stems
Femoral Hip Stem
888.3350 JDI Hip joint metal/polymer semiconstrained cemented prosthesis Class II
888.3353 LZO Hip joint metal/ceramic/polymer, cemented or non-porous, uncemented prosthesis Class II
Orthopedics/87/JDI/LZO
PROFEMUR® Z Plasma-Coated Hip Stem, K111699
STEM Hip Replacement System, K021346
Tab 07: Page 1 of 3
FEB 5 2013
1
PROFEMUR® Z Classic Stems Special 510(k)
510(k) Summary
Image /page/1/Picture/3 description: The image shows the word "WRIGHT." in all caps. Below the word is a logo that appears to be two stylized W's that are stacked on top of each other. The logo is in black and the word is in black.
(a)(4) Device Description
The purpose of this submission is to add a monolithic femoral neck option to the PROFEMUR® Z Hip System. The PROFEMUR® Z Classic Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Z Classic Stems are available in 9 sizes (1-9) and are available in two surface finish options: gritblast or titanium plasma spray conforming to ASTM F1580. Each size is available with either a long or short fixed femoral neck and all sizes are available in two neck offset options, Standard (neutral) and Extended (varus). The surface finish options, neck lengths, and neck offset are designed to create options identical to those available with the predicate modular devices.
(a)(5) Indications for Use
The PROFEMUR® Z 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® Z 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.
(a)(6) Technological Characteristics of the Device
The indications for use of the PROFEMUR® Z Classic Stems are identical to those for the predicate devices (K111699, K021346). The subject devices are made from an identical titanium alloy (ASTM F620) as the predicate devices. The PROFEMUR® Z Classic Stems are designed to provide identical range of sizes, surface finishes, neck lengths, and neck offsets as those provided by the modular predicates. The subject device design is identical to that of the predicate devices with the exception of featuring a monolithic neck design and a slightly modified impaction slot.
(b)(1) Nonclinical Testing
The PROFEMUR® Z Classic Stems were evaluated in proximal and distal fatigue tests in accordance with ISO 7206-4, 6, and 8 and satisfied the acceptance criteria of each. Range of motion was evaluated in accordance with ISO 21535 and the subject device satisfied the acceptance criteria. The titanium plasma spray coating is applied according to WMT specification and is identical to that used in the predicate device (K111699). The titanium plasma spray coating was verified by testing present within a vendor Master File and summarized within this premarket notification.
Headquarters
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com
Tab 07: Page 2 of 3
2
PROFEMUR® Z Classic Stems Special 510(k) 510(k) Summary
Image /page/2/Picture/2 description: The image shows the word "WRIGHT." in all capital letters. Below the word is a stylized design that appears to be a logo or emblem. The text and design are in black and the background is white.
(b)(2) Clinical Testing
Clinical data was not provided for the subject devices.
(b)(3) Conclusions
The indications for use and fundamental scientific technology of the PROFEMUR® Z Classic Stems are identical to those of the predicate devices. 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® Z Classic Stems is adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.
Headquarters Arlington, TN 38002 Wright Medical Technology, Inc. 5677 Airline Road www.wmt.com
Tab 07: Page 3 of 3
3
Image /page/3/Picture/0 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 resembling an eagle or bird in flight, composed of three curved lines.
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
Wright Medical Technology, Incorporated % David Fitch, Ph.D. Clinical Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Letter dated: February 5, 2013
Re: K123434
Trade/Device Name: PROFEMUR®Z Classic 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 Dated: January 7, 2013 Received: January 8, 2013
Dear Dr. Fitch:
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 (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
4
Page 2 - Dr. David Fitch
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PROFEMUR® Z Classic Stems Special 510(k) Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K123434
Device Name: PROFEMUR® Z Classic Stems
Indications for Use:
The PROFEMUR® Z 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® Z 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.
Prescription Use X ' AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael C. Owens 2013.02.05 12:11:26 -05'00'
Division of Orthopedic Devices
Headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone www.wmt.com
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