(90 days)
Not Found
No
The summary describes a physical implant (acetabular cup) made of polyethylene with different sizes. There is no mention of software, algorithms, image processing, AI, ML, or performance metrics typically associated with AI/ML devices.
Yes
The device is an acetabular cup for hip arthroplasty, which is a medical procedure to treat a disease or injury, thus making it a therapeutic device.
No
Explanation: The device is an acetabular cup, which is an implant used in hip arthroplasty for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical component made of ultra high molecular weight polyethylene, which is a hardware material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cemented use in hip arthroplasty where the acetabular socket needs restructuring." This describes a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical implant (an acetabular cup) made of polyethylene, designed to be surgically placed in the hip.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
This device is a medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
The PE-PLUS Acetabular Cup is made of an ultra high molecular weight polyethylene (ASTM F 648) and accommodates three ball head sizes (diameters of 22, 28, and 32). Twelve sizes are available for the 22 and 28 head diameters, (cup sizes 42 to 64, in 2mm increments) and nine cup sizes for the 32 head diameter (cup sizes 48 to 64, in 2mm increments).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Extensive literature has been provided. Performance data:
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.
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.
Not Found
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).
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
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0
SEP 2 3 1999
510(k) Summary of Safety and Effectiveness
June 25, 1999
- PE-PLUS Acetabular Cup Trade name:
- Common name: Cemented Acetabular Cup
- Prosthesis, hip, semi-constrained, metal/polymer, cemented Classification 21 CFR 888.3350 (87 JDI) name:
- Implex HEP Acetabular Cup System, Cemented (K971705, 08-06-97); Equivalence: Howmedica Duration Stabilized UHMWPE Exeter All Plastic Acetabular Component (K972792, 10-16-97)
- The PE-PLUS Acetabular Cup is made of an ultra high molecular weight Characteristics: polyethylene (ASTM F 648) and accommodates three ball head sizes (diameters of 22, 28, and 32). Twelve sizes are available for the 22 and 28 head diameters, (cup sizes 42 to 64, in 2mm increments) and nine cup sizes for the 32 head diameter (cup sizes 48 to 64, in 2mm increments).
- The PE-PLUS Acetabular Cup is intended for cemented use in hip Indications: arthroplasty where the acetabular socket needs restructuring.
- Contraindications include acute or chronic infections (local or systemic), Contraindications: 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.
Extensive literature has been provided. Performance data:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 23 1999
Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122
Re: K992153 PE-Plus Acetabular Cup Product Code: JDI Class: II Dated: June 25, 1999 Received: June 25, 1999
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 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 (OS) 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.
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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 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 at (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
510(k) Number (if known):
Device Name:
PE-PLUS Acetabular Cup
Indications For Use:
The PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring.
DaOalley
ision of General Restorativ 510(k) Number
1984
Prescription Use
(Per 21 CFR 801.109)