(21 days)
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No
The document describes a mechanical hip implant system with modifications to the trunnion design and size options. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an "Exeter V40™ Hip System" intended for "total hip replacement" to treat various joint diseases and correct functional deformities, which are therapeutic interventions.
No
The text indicates the device is an Exeter Hip System, which is a prosthetic intended for total hip replacement, rather than for diagnosing conditions.
No
The device description clearly outlines physical components of a hip replacement system (stems, heads, trunnion, centralizer), indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "total hip replacement" and addresses conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a surgical implant used in the body.
- Device Description: The description details components of a hip implant (stems, heads, trunnion, centralizer). These are physical devices implanted during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting diseases or conditions in vitro, or providing information for diagnosis or monitoring based on such analysis.
IVD devices are used to examine specimens outside of the body to provide information about a person's health. This device is a therapeutic implant used inside the body.
N/A
Intended Use / Indications for Use
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
- Rheumatoid arthritis, .
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, .
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with ● head involvement that are unmanageable using other techniques.
Product codes
JDI
Device Description
This Special 510(k) covers a modified Exeter Hip System which differs from the existing, predicate Exeter Hip System primarily in that it features a different trunnion known as the V40™ Taper. In addition to the change in Exeter Hip Stems and Heads from the predicate trunnion design to the newer V40™ Taper, this submission includes some additional stem and head sizes, the addition of an insertion dimple on the stems, reduction in stem neck diameter, and a new wingless version of the stem centralizer component.
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
Indicated Patient Age Range
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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
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Summary of Performance Studies
The subject modified hip stems have successfully endured testing in accordance with ISO 7206-4 and 7206-6. Testing of commercially available Zirconia V40™ Femoral Heads demonstrated their suitability for use with the subject hip stems.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
JUN 1 5 2001
Modified Exeter Hip System with V40™ Taper
Special 510(k) Premarket Notification
Special 510(k) Summary - Modified Exeter Hip System with V40™ Taper
Proprietary Name: Common Name : Classification Name and Reference:
Proposed Regulatory Class : Device Product Code : For Information contact:
Exeter Hip System with V40TM Taper Artificial Hip System Prosthesis. Hip. Semi-Constrained. Metal/Polymer/Metal, Cemented, 21 CFR $888.3350 Class II 87 JDI Nancy J. Rieder Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401 Phone: (201) 934-4364 Fax: (201) 760-8435
Description/Technologicol Comparison
This Special 510(k) covers a modified Exeter Hip System which differs from the existing, predicate Exeter Hip System primarily in that it features a different trunnion known as the V40™ Taper. In addition to the change in Exeter Hip Stems and Heads from the predicate trunnion design to the newer V40™ Taper, this submission includes some additional stem and head sizes, the addition of an insertion dimple on the stems, reduction in stem neck diameter, and a new wingless version of the stem centralizer component.
Intended Use
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
- Rheumatoid arthritis, .
Page 3
1
Modified Exeter Hip System with V40™ Taper
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, .
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
Testing Summary
The subject modified hip stems have successfully endured testing in accordance with ISO 7206-4 and 7206-6. Testing of commercially available Zirconia V40™ Femoral Heads demonstrated their suitability for use with the subject hip stems.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
JUN 1 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nancy J. Rieder Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K011623
Trade Name: Exeter Hip System with V40" Taper Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: May 24, 2001 Received: May 25, 2001
Dear Ms. Rieder:
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 Regulation (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 regulation may result in regulatory 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.
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.
3
Page 2 - Ms. Nancy J. Rieder
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 additionally, of 59. Additionally, for questions on the promotion and advertising of your device, (2017) 594-1639. Tradition 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 mormaton on Jour Soll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mesturth
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
510(k) Number (if known): K011623
Device Name: Modified Exeter Hip System with V40TM Taper
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis, .
- Rheumatoid arthritis, .
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, .
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with ● head involvement that are unmanageable using other techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use
Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011623