(83 days)
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Not Found
No
The summary describes a mechanical hip stem and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the "reduction or relief of pain and/or improved hip function," which are therapeutic outcomes.
No
The provided text describes a medical device, the "Cemented EXTEND™ Hip Stem," which is used for treatment in total hip arthroplasty, not for diagnosing conditions.
No
The device description clearly states it is a "monolithic design femoral component" made of "cast cobalt chrome alloy," indicating it is a physical implant, 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, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The description clearly states this is a "Cemented EXTEND™ Hip Stem," a "monolithic design femoral component" made of "cast cobalt chrome alloy." This is a physical implant designed to be surgically placed inside the body.
- Intended Use: The intended use describes the conditions for which the hip stem is used in total hip arthroplasty, which is a surgical procedure.
This device is a surgical implant, not an IVD.
N/A
Intended Use / Indications 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 nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This device is for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDI and LZO
Device Description
The Cemented EXTEND™ Hip Stem is a monolithic design femoral component. The Cemented EXTEND™ Hip Stem is cast from cobalt chrome alloy (ASTM F-75). The stem is available straight with standard or reduced flare, or bowed with a calcar platform. It is designed for use with bone cement.
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 (proximal femur with head involvement)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EXTENDTM Hip System demonstrates acceptable fatigue strength.
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.
EXTENDIM Hip System
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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§ 888.3350 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/0 description: The image shows the text "WRIGHT MEDICAL TECHNOLOGY, INC." in a bold, sans-serif font. Below this text is the address "5677 AIRLINE ROAD ARLINGTON, IN 38002". The text is black and the background is white, creating a high contrast image.
Contact Person: Date:
Kim Tompkins November 19, 1997
510(k) Summa
Trade/Proprietary Name: Common Name: Classification: Predicate Device:
Cemented EXTEND™ Hip Stem Femoral Hip Stem Class II EXTENDIM Hip System, Wright Medical Technology, Inc
NOV 2 4 1997
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92
Description/Intended Use
1).
The Cemented EXTEND™ Hip Stem is a monolithic design femoral component. The The Ceinenton EXTER & From cast cobalt chrome alloy (ASTM F-75). The stem is available straight with standard or reduced flare, or bowed with a calcar platform. It is available suaight with standad of rechnology, Inc. cobalt chrome alloy or alumina ceramic femoral heads. It is designed for use with bone cement.
The Cemented EXTEND™ Hip Stem in total hip arthroplasty for reduction or relief of The Celliented EATER in 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 nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Testing
The EXTBNDTM Hip System demonstrates acceptable fatigue strength.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
··············
Ms. Kim Tompkins Director, Clinical and Requlatory Affairs Wright Medical Technology, Inc. 5677 Airline Road 38002 Arlington, Tennessee
NOV 2 4 1997
Re: K973296 Cemented EXTEND™ Hip Stem Trade Name: Regulatory Class: II Product Codes: JDI and LZO Dated: August 29, 1997 September 2, 1997 Received:
Dear Ms. Tompkins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Kim Tompkins
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Wright Medical Technology, Inc. Premarket Notification -Cemented EXTEND™ Hip Stem
C. Indications for Use of the Device
Page 1 of 1
510(k) Number (if known): 1973296
Cemented EXTEND™ Hip Stem Device Name:
Indications 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, 1) avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2)
- correction of functional deformity; 3)
- revision procedures where other treatments or devices have failed; and, 4)
- treatment of nonunion, femoral neck and trochanteric fractures of the ર) proximal femur with head involvement that are unmanageable using other techniques.
This device is for cemented use only.
(Please do not write belo
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K973296
Prescription Use_X_ (Per 21 CFR 801.109) Or
Over-the-Counter Use
(Optional Format 1-2-96)
000010