(102 days)
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Not Found
No
The document describes a physical medical device (hip stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a hip stem used in total hip arthroplasty to reduce pain and improve hip function in patients with various degenerative joint conditions, which aligns with the definition of a therapeutic device.
No
The document describes a hip stem implant, which is a prosthetic device used in surgery, not a device for diagnosing medical conditions.
No
The device description clearly describes a physical hip stem, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a hip implant (a cemented hip stem) used in surgical procedures (total hip arthroplasty) to replace a damaged hip joint. It is a physical device implanted into the body, not a device that analyzes samples taken from the body.
The intended use and device description are consistent with a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROFEMUR® XTR Cemented Hip Stem is 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 rhcumatoid arthritis;
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LZO, JDL, KWA
Device Description
The design features of the PROFEMUR® XTR Cementcd Hip Stem are summarized bclow:
- The PROFEMUR® XTR Ccmented Hip Stem is available in 5 sizes and is intended . for use with previously cleared WMT modular necks.
- The PROFEMUR® XTR Cemented Hip Stem features a dual tapering stem and . polished surface.
- The PROFEMUR® XTR Ccmented Hip Stem is intended for cemented use only. .
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
Not Found
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.
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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.
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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).
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§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image shows the word "WRIGHT." in large, bold, stencil-like letters. Above the word, there is the text "K052915 Page: 1/2". Below the word, there is a design of three stylized, horizontal lines that are stacked on top of each other.
JAN 2.7 2006
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Sale Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® XTR Hip Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | January 19, 2006 |
| Contact Person: | Theresa Leister Regulatory Affairs Specialist II |
| Proprietary Name: | PROFEMUR® XTR Cemented Hip Stem |
| Common Name: | Cemented Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3350 Hip joint metal/polymer, semi- constrained, cemented prosthesis - Class II 21 CFR 888.3320 Hip joint metal/ metal semi- constrained, with a cemented acetabular component prosthesis -- Class III 21 CFR 888.3330 Hip joint metal/ metal semi- constrained, with an uncemented acetabular component prosthesis - Class III 21 CFR 888.3353 Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ JDI, LZO, JDL, KWA |
headquarters
Wright Medical Technology, Inc.
5677 Airline Road
Arlington TN 38002 901.867.9971 phone www.wmt.com
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany
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Image /page/1/Picture/1 description: The image shows the word "WRIGHT" in large, bold, sans-serif font. Below the word is a graphic design element consisting of three stacked, angled shapes that resemble stylized wings or chevrons. In the upper right corner of the image, there is some handwritten text that appears to be a document number or page reference, with the numbers "2052915" and the word "Page" followed by a number.
DEVICE INFORMATION
A. INTENDED USE
The PROFEMUR® XTR Cemented Hip Stem is 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 rhcumatoid arthritis;
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.
B. DEVICE DESCRIPTION
The design features of the PROFEMUR® XTR Cementcd Hip Stem are summarized bclow:
- The PROFEMUR® XTR Ccmented Hip Stem is available in 5 sizes and is intended . for use with previously cleared WMT modular necks.
- The PROFEMUR® XTR Cemented Hip Stem features a dual tapering stem and . polished surface.
- The PROFEMUR® XTR Ccmented Hip Stem is intended for cemented use only. .
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material, type of interfacc, and design features of the PROFEMUR® XTR Cemented Hip Stem are substantially equivalent to the devices previously cleared for market. The safety and effectiveness of the PROFEMUR® XTR Cemented Hip Stem are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
2
Image /page/2/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 AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
JAN 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Theresa Leister Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K052915
Trade/Device Name: Profemur XTR Cemented Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis Regulatory Class: III Product Codes: KWA, JDL, LZO, JDI Dated: January 16, 2006 Received: January 18, 2006
Dear Ms. Leister:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
3
Page 2 – Ms. Theresa Leister
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
ನ್ನಾ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PROFEMUR® XTR Cemented Hip Stem INDICATIONS STATEMENT
KOSZ915 510(k) Number (if known):
Device Name: PROFEMUR® XTR Cemented Hip Stem
Indications For Use:
The PROFEMUR® XTR Cemented Hip Stem is 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, רי
- revision procedures where other treatments or devices have failed 4.
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)
MS
(Division Sign-Off) (Division of General, Restorative, Division of of of of and Neurological Devices
510(k) Number K082915