(140 days)
Not Found
Not Found
No
The device description focuses on the materials and mechanical components of a bipolar hip prosthesis, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended to treat and correct medical conditions such as degenerative joint disease, rheumatoid arthritis, functional deformity, and fractures, which falls under the definition of a therapeutic device.
No
The device description and intended use indicate it is an implantable prosthetic device (a bipolar head) used for treatment and correction of conditions of the proximal femur, not for diagnosing them.
No
The device description clearly details physical components made of Cobalt Chrome alloy and UHMW polyethylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's purpose in treating various conditions of the femoral joint, such as osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a physical implant (a bipolar head) made of materials like Cobalt Chrome alloy and UHMW polyethylene. It is designed to be surgically implanted to replace or repair a damaged joint. This is a medical device, not a diagnostic reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
In summary, this device is a surgical implant used for the treatment of musculoskeletal conditions, which falls under the category of a medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended to be used for:
- femoral noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
- rheumatoid arthritis, 2.
- correction of functional deformity, 3.
- revision procedures where other treatments or devices have failed, and 4.
-
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Product codes
KWY
Device Description
A bipolar head which is preassembled. Outer head is made from Cobalt Chrome alloy ASTM F75 and sizes range from 38mm to 62mm in 1mm increments. An UHMW polyethylene insert will be pressed into the inner surface of the outer head during the manufacturing process. This polyethylene insert will articulate with an inner femoral head. The inner head diameter will be 22mm for outer head diameters from 38mm to 55mm and 26mm for outer diameters from 56mm to 62mm. The inner head will be pressed into the poly insert in the operating room using a bipolar head assembly device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral
Indicated Patient Age Range
Not Found
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
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
AUG 21 1998
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The characters appear to be 'K981238'. The writing style is casual, and the characters are slightly distorted, giving them a unique, handwritten appearance. The image is in black and white, with the characters standing out against the white background.
510(k) SUMMARY
Device:
Classification Name:
Classification No.: Common / Usual Name: Proprietary Name:
Prosthesis, Hip, Hemi-, Femoral, Metal / Polymer, Cemented or Uncemented
87KWY Bipolar femoral head Whiteside Biomechanics, Inc. Bipolar Femoral Head
Manufacturer Identification:
Whiteside Biomechanics, Inc. 12634 Olive Blvd. St. Louis, MO 63141
1932213 Establishment Registration Number:
Device Description:
A bipolar head which is preassembled. Outer head is made from Cobalt Chrome alloy ASTM F75 and sizes range from 38mm to 62mm in 1mm increments. An UHMW polyethylene insert will be pressed into the inner surface of the outer head during the manufacturing process. This polyethylene insert will articulate with an inner femoral head. The inner head diameter will be 22mm for outer head diameters from 38mm to 55mm and 26mm for outer diameters from 56mm to 62mm. The inner head will be pressed into the poly insert in the operating room using a bipolar head assembly device.
Intended Use:
This device is intended to be used for :
- femoral noninflammatory degenerative joint disease including osteoarthritis and 1. avascular necrosis,
- rheumatoid arthritis, 2.
- correction of functional deformity, 3.
- revision procedures where other treatments or devices have failed, and 4.
-
- treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Additional Information:
This femoral head is made of Cobalt Chrome with a UHMW poly insert. The inner head will be pressed into the polyethylene insert in the OR. This femoral head will be sterilized by 100% ethylene oxide in nitrogen according to the AAMI Guidelines for sterilization. Resterilization is NOT recommended.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 21 1998
Michael C. Wall, R.N. Official Correspondent Whiteside Biomechanics, Inc. 12634 Olive Boulevard St. Louis, Missouri 63141
Re: K981238 Bipolar Femoral Head Trade Name: Regulatory Class: II Product Code: KWY Dated: June 29, 1998 Received: July 23, 1998
Dear Mr. Wall:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 CER 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 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 - Michael C. Wall, R.N.
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,
Russell S. Hogan
An 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
510(k) Number (if known):
Device Name: Whiteside Biomechanics, Inc. Bipolar Femoral Head
Indications For Use:
-
- Noninflammatory degenerative joint disease including osteoarthritis.
-
- Avascular necrosis.
- 3 . Correction of functional deformity.
- 4 . Revision procedures where other treatments or devices have failed.
- 5 . Treatment of femoral neck and trochanteric fractures of the proximal femur with head involvement and non-union of femoral neck fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) ાર
Over-The-Counter Use `No
(Optional Format 1-2-96)
Roswell L. Kenyon
-+: