(92 days)
Not Found
No
The summary describes a mechanical implant (acetabular cup system) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is an Acetabular Cup System used in total hip replacement, which is a therapeutic intervention for conditions like osteoarthritis, rheumatoid arthritis, and bone tumors, aiming to alleviate pain and restore function.
No
The device description indicates it is an acetabular cup system used as part of a total hip replacement, which is a treatment rather than a diagnostic tool.
No
The device description clearly states it is comprised of physical components: a coated outer shell manufactured from titanium alloy and a UHMWPE liner force fitted into a cobalt chrome metal dome casing. This indicates a hardware medical device, not a software-only one.
Based on the provided information, the Equator Plus™ Acetabular Cup System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are 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 Equator Plus™ Acetabular Cup System is a physical implant designed to be surgically placed within the human body as part of a hip replacement. It is made of titanium alloy, UHMWPE, and cobalt chrome.
- Intended Use: The intended use is to replace a damaged or diseased acetabulum (hip socket) in patients with specific conditions affecting the hip joint. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
Therefore, the Equator Plus™ Acetabular Cup System is a medical device, specifically a surgical implant, and not an IVD.
N/A
Intended Use / Indications for Use
The Equator Plus™ Acetabular Cup System has the following indications for use:
- · The patient should be skeletally mature.
- · The patient's condition should be due to one or more of the following:
-
- Osteoarthritis.
-
- Rheumatoid arthritis.
-
- Tumor conditions involving the upper third of the femur or of the Acetabular.
-
- Ankylosing spondylitis.
-
- Psoriatic arthritis.
-
- Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
-
- Non union of femoral neck fracture or avascular necrosis of the femoral head.
-
- Post-traumatic fracture/dislocation of the hip.
-
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
-
- Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
-
- Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
-
Product codes
JDI, LWJ, MAY
Device Description
The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femur, Acetabular
Indicated Patient Age Range
Skeletally mature
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)
SUMMANT of TED III. has provided analytical and mechanical testing to r orthand Orthopactics, Ltd. Has proved and compliance to standards for the Equator Plus™ Acetabular Cup System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The Equator Plus™ Acetabular Cup System has been qualified for use with the Margron Hip Replacement System (cleared under K032641).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
OCT 7 - 2005
Image /page/0/Picture/1 description: The image shows the text "510(k) Summary" in a large, bold font. The text is black and the words are underlined. The text is centered on the image.
SUBMITTED FOR:
| Company Name: | Portland Orthopaedics Limited | |
|---|---|---|
| Address: | Unit 3, 44 McCauley St | |
| Matraville, NSW, 2036 Australia | ||
| Telephone: | ++ 61-2-9666-8444 | |
| Fax: | ++61-2-9666-8544 | |
| SUBMITTED BY: | Elaine Duncan, M.S.M.E., RAC | |
| President, Paladin Medical, Inc. | ||
| PO Box 560 | ||
| Stillwater, MN 55082 | ||
| Telephone: | 715-549-6035 | |
| Fax: | 715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | July 5, 2005, revised September 26, 2005 | |
| TRADE NAME: | Equator Plus™ Acetabular Cup System | |
| COMMON NAME: | Acetabular Cup System | |
| DEVICE PROCODE & PANEL: | : JDI, LWJ, MAY Orthopaedics 87 |
DESCRIPTION of the DEVICE:
The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.
SUBSTANTIAL EQUIVALENCE INFORMATION
The Equator Plus™ Acetabular Cup System described in this submission is substantially equivalent to the predicate devices in the same classification and procode designation. Testing and materials qualification have demonstrated that the differences in the Equator Plus ™ Acetabular Cup System do not raise any new issues of safety and effectiveness. The Equator Plus™ Acetabular Cup System has been qualified for use with the Margron Hip Replacement System (cleared under K032641).
INDICATIONS FOR USE:
The Equator Plus™ Acetabular Cup System has the following indications for use:
- · The patient should be skeletally mature.
- · The patient's condition should be due to one or more of the following:
-
- Osteoarthritis.
-
- Rheumatoid arthritis.
-
1
510(k) Summary-Continued
- Tumor conditions involving the upper third of the femur or of the Acetabular.
-
- Ankylosing spondylitis.
-
- Psoriatic arthritis.
-
- I sollatie urnifitib.
- Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
-
- Non union of femoral neck fracture or avascular necrosis of the femoral head.
-
- Post-traumatic fracture/dislocation of the hip.
-
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
-
- Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
-
- Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
SUMMARY of TESTING:
SUMMANT of TED III. has provided analytical and mechanical testing to r orthand Orthopactics, Ltd. Has proved and compliance to standards for the Equator Plus™ Acetabular Cup System.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human figures, representing the department's focus on health and well-being. The text is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2005
Portland Orthopaedics Limited c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K051844
Trade/Device Name: The Equator Plus™ Acetabular Cup System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MAY, JDI, LWJ Dated: September 26, 2005 Received: September 27, 2005
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Ms. Elaine Duncan, M.S.M.E., RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark Miller
C Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Equator Plus™ Acetabular Cup System Device Name:
The Equator Plus™ Acetabular Cup System has the following indications for use:
· The patient should be skeletally mature.
- · The patient's condition should be due to one or more of the following:
-
- Osteoarthritis.
-
- Rheumatoid arthritis.
-
- Tumor conditions involving the upper third of the femur or of the Acetabular.
-
- Ankylosing spondylitis.
-
- Psoriatic arthritis.
-
- Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
-
- Non union of femoral neck fracture or avascular necrosis of the femoral head.
-
- Post-traumatic fracture/dislocation of the hip.
-
- Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
-
- Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
-
- Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_k o 51844