(73 days)
Not Found
Not Found
No
The document describes a physical medical device (femoral stem) and its intended use and design features. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The sections specifically looking for mentions of AI, DNN, or ML are marked as "Not Found".
Yes
The device is clearly indicated for the reduction or relief of pain and/or improved hip function, which are therapeutic goals.
No
The provided text describes a femoral stem used in total hip arthroplasty, which is a surgical implant for treatment, not a device used for diagnosis.
No
The device description clearly details a physical implant (femoral stem) with specific material properties, sizes, and surface finishes, indicating it is a hardware medical device.
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 (femoral stem) used in total hip arthroplasty to treat conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics of a surgical implant (sizes, taper, surface finish, shape). This aligns with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The ATH Femoral 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 necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint discase such as rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of fractures that are unmanageable using other techniques.
Product codes
JDI, LPH
Device Description
The design features for Wright Medical Technology's ATH Femoral Stem are as follows:
- Sizes range from 4mm to 13mm .
- Wright Medical Technology's standard 12/14 SLT taper .
- . Grit blast surface finish
- Proximal body with double wedge shape .
- Proximal body has rounded off rectangular cross-section .
- Tapered distal stem with rounded off rectangular cross-section .
- Dimple on lateral shoulder .
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a document with the text "510(K) SUMMARY OF SAFETY AND EFFECTIVENESS" and the Wright Medical logo. The document also has the date "MAR 11 2004" and the handwritten text "K034028 page 1 of 2". The document appears to be a summary of safety and effectiveness for a medical device.
In accordance with the Food and Drug Administration Rule to implement provin Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information scrves as a Summary of Safety and Effectiveness for the ATH Femoral Stem.
510(K) SUMMARY
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | December 19, 2003 |
| Contact Person: | Jeanine H. Redden |
| Regulatory Affairs Associate | |
| Proprietary Name: | ATH Femoral Stem |
| Common Name: | HIP PROSTHESIS |
| Classification Name and Reference: | 21 CFR 888.3358 Prosthesis, hip, semi-constrained, |
| metal/polymer, porous uncemented- Class II | |
| 21 CFR 888.3350 Prosthesis, hip, semi-constrained, | |
| metal/polymer, cemented- Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/LPH/JDI |
DEVICE INFORMATION
A. INTENDED USE
The ATH Femoral 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 necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint discase such as rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of fractures that are unmanageable using other techniques.
B. DEVICE DESCRIPTION
The design features for Wright Medical Technology's ATH Femoral Stem are as follows:
- Sizes range from 4mm to 13mm .
- Wright Medical Technology's standard 12/14 SLT taper .
- . Grit blast surface finish
headquarters
5677 Airline Boad Arlington, IN 38002 Wright Medical Technology, Inc.
901.867.9971 phone
international subsidianes 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
1
K034028
page 2 of 2
And Children Children Children
- Proximal body with double wedge shape .
- Proximal body has rounded off rectangular cross-section .
- Tapered distal stem with rounded off rectangular cross-section .
- Dimple on lateral shoulder .
C. SUBSTANTIAL EQUIVALENCE INFORMATION
Wright Medical Technology's ATH Femoral Stem is substantially cquivalent to the wing.it insured "Founded" "The safety and effectiveness of the ATH predicate actives provised by the substantial equivalent information, matcrials data, and testing results provided within this Premarket Notification.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wings, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
MAR 1 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K034028
Trade/Device Name: ATH Femoral Stem Implant Regulation Numbers: 21 CFR 888.3350 and 21 CFR 888.3358 Regulation Names: Spinal interlaminal fixation orthosis, Hip joint metal/polymer/metal semi-constrained pouous-coated uncemented prosthesis Regulatory Class: II Product Codes: JDI and LPH Dated: February 20, 2004 Received: February 23, 2004
Dear Ms. Redden:
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 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.
3
Page 2 - Ms. Jeanine H. Redden
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K034028
ATH Femoral Stem Device Name:
Indications For Use:
The ATH Femoral 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 necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of fractures that are unmanageable using other techniques.
Prescription Use (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)
Mark N Milliman
- Restorative and Neurological Devices
Page 1 of 1
510(k) Number K034028