(133 days)
Not Found
No
The summary describes a mechanical hip prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as being for "arthroplasty therapy" as a result of femoral neck fractures, directly indicating its therapeutic purpose.
No
The device is a prosthesis intended for arthroplasty therapy due to femoral neck fractures, not for diagnosing conditions.
No
The device description clearly states it is a physical hip joint prosthesis comprised of a CoCrMo shell, polyethylene insert, and security ring, indicating it is a hardware device.
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 about a person's health.
- Device Description: The provided description clearly states the device is a "one-piece hip joint prosthesis comprised of a CoCrMo shell, a polyethylene insert and polyethylene security ring." This is an implantable device used in surgery.
- Intended Use: The intended use is "in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant." This describes a surgical procedure and the device's role within it.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Plus Bipolar Prosthesis CoCrMo in intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.
Product codes
KWY
Device Description
The PLUS Bipolar Prosthesis CoCrMo is a one-piece hip joint prosthesis comprised of a CoCrMo shell, a polyethylene insert and polyethylene security ring. The advantages are 1) self-centering effect of the positive-excentric Bipolar prosthesis promotes the neutral position of the implant, 2) protects the acetabulum because the main articulation is between the implant femoral head and the Bipolar prosthesis. 3) optimum protection against the risk of dislocation with a built-in security ring, 4) the polyethylene insert is firmly fastened into the metal shell which prevents micromotion and polyethylene wear, 5) highly polished metal surface minimizes friction between implant and acetabulum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint femoral (hemi-hip)
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)
None provided at this time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
NOV 25 1998
K 982447
Premarket Notification 510(k) PLUS Bipolar Prosthesis CoCrMo July 8, 1998
510(k) Summary of Safety and Effectiveness
September 11, 1998
- PLUS Bipolar Prosthesis CoCrMo Trade name:
- Bipolar Hip Joint Prosthesis Common name:
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented Classification name: prosthesis (87KWY)
Foundation Hip System, Bipolar Assembly, Encore Orthopedics, Equivalence: Austin, Texas (K953510).
- The PLUS Bipolar Prosthesis CoCrMo is a one-piece hip joint Characteristics: prosthesis comprised of a CoCrMo shell, a polyethylene insert and polyethylene security ring. The advantages are 1) self-centering effect of the positive-excentric Bipolar prosthesis promotes the neutral position of the implant, 2) protects the acetabulum because the main articulation is between the implant femoral head and the Bipolar prosthesis. 3) optimum protection against the risk of dislocation with a built-in security ring, 4) the polyethylene insert is firmly fastened into the metal shell which prevents micromotion and polyethylene wear, 5) highly polished metal surface minimizes friction between implant and acetabulum.
- The PLUS Bipolar Prosthesis CoCrMo is intended for use in Indications: arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implants.
- Contraindications include acute or chronic infections (local or Contraindications: systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
- None provided at this time. Performance data:
1
Image /page/1/Picture/10 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 1998
Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122
K982447 Re: Plus Bipolar Prosthesis CoCrMo Trade Name: Regulatory Class: II Product Code: KWY Dated: September 11, 1998 September 14, 1998 Received:
Dear Mr. Loch:
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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 In addition, FDA may publish further announcements action. 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 - Mr. Hartmut Loch
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 requlation (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
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Page 1 of 1
510(k) Number (if known): K982447
Device Name: Plus Bipolar Prosthesis CoCrMo
Indications For Use:
The Plus Bipolar Prosthesis CoCrMo in intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ice Evaluation (SDE)
Prescription Use_y2 (Per 21 CFR 801.1b9)
OR
Over-The-Counter Use K6
(Optional Format 1-2-96)