(108 days)
Not Found
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a total hip arthroplasty system intended to reduce or relieve pain and improve hip function, aligning with the definition of a therapeutic device.
No
The device is a hip implant (hip stem), which is a prosthetic device for hip arthroplasty, not a diagnostic tool. Its intended use is for treatment (pain relief, improved function, correction of deformity), not diagnosis.
No
The device description clearly states it is a physical hip stem made of titanium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip arthroplasty to treat conditions affecting the hip joint. This is a surgical procedure performed on the patient's body.
- Device Description: The device is a hip stem, which is an implantable medical device.
- 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 samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Wright Medical total hip systems are indicated 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;
- correction of functional deformity; and, 3.
-
- revision procedures where other treatments or devices have failed
The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI
Device Description
- . Cementless modular stems
- Available in 9 sizes .
- Manufactured from Titanium alloy with a heavy grit blasted surface .
The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.
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® Z Revision Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8.
Clinical Testing: Clinical data was not provided for the class II hip 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.
Not Found
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
9 2012 AUG
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® Z Revision Hip Stem .
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Wright Medical Technology, Inc. 5677 Airline Rd, Arlington TN, 38002 (800) 238-7188
February 7, 2012
Yuan Li, Ph.D Regulatory Affairs Specialist
PROFEMUR® Z Revision Hip Stem
Hip Stem
888.3353 LZO Hip joint metal/ceramic/ polymer, cemented or non-porous, uncemented prosthesis Class II
888.3350 JDI Hip joint metal/polymer semiconstrained cemented prosthesis Class II
Subject Product Code and Panel Code:
Predicate Devices:
Orthopedics/87/LZO, JDI
STEM Hip Replacement System 510(k)s: K021346
PRESERVE HIP STEM 510(K): K112080
Device Information
A. Intended Use
Wright Medical total hip systems are indicated 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;
- correction of functional deformity; and, 3.
-
- revision procedures where other treatments or devices have failed
The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.
1
K171221
B. Device Description
Design features of the subject stems are summarized below:
- . Cementless modular stems
- Available in 9 sizes .
- Manufactured from Titanium alloy with a heavy grit blasted surface .
The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.
C. Nonclinical Testing
The PROFEMUR® Z Revision Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8.
D. Clinical Testing
Clinical data was not provided for the class II hip stem.
E. Conclusions
The indications for use of the PROFEMUR® Z Revision Hip Stems are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® Z Revision Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle. In the center of the circle is a stylized symbol that resembles an eagle or bird with outstretched wings. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Yuan Li 5677 Airline Rd. Arlington, TN 38002 US
AUG 9 2012
Re: K121221
Trade/Device Name: Profemur Z Revision Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Cemented or Non-Porous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, JDI Dated: July 9, 2012 Received: July 10, 2012
Dear Mr. Li:
We have reviewed vour 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
3
Page 2 - Mr. Yuan Li
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Mikkelson
Mark N. Melkerson Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KIZIZZI
Indications for Use
510(k) Number (if known):
Device Name: PROFEMUR® Z Revision Hip Stem
Indications For Use:
-
- 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 Revision Hip Stem is intended for cementless 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)
Aho
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
从121221 510(k) Number