(129 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of a hip implant component, with no mention of AI or ML.
Yes
The device is intended to treat conditions such as femoral neck and trochanteric fractures and osteonecrosis of the femoral head, which makes it a therapeutic device.
No
Explanation: The device description clearly states "The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip." This indicates it is a prosthetic implant used for treatment in surgery, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components made of materials like UHMWPE, cobalt chrome, and Ti-6Al-4v, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Description: The Apex Hip System Bipolar Head is a physical implant designed to replace a part of the hip joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for hemiarthroplasty of the hip, which is a surgical procedure to replace a portion of the hip joint. This is a treatment, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- . Femoral neck and trochanteric fractures of the proximal femur,
- Osteonecrosis of the femoral head;
- Revision procedures where other devices or treatments for these indications have failed.
Product codes (comma separated list FDA assigned to the subject device)
KWY
Device Description
The Apex Hip System Bipolar Head consists of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have an inner diameter that mates with a 28 mm diameter femoral head. The Apex Hip System Bipolar Head may be used in conjunction with an Apex Hip System femoral stem (K060072) for hemiarthroplasty.
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)
Non-Clinical Test Summary: The following tests were conducted:
- Push-out and lever-out testing.
- Locking ring spring storage heat tolerance test (150°F).
- ETO sterilization validation, SAL 10^6
Clinical Test Summary: No clinical studies were performed.
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
§ 888.3390 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
Image /page/0/Picture/1 description: The image shows the text 'K100151' in a handwritten style. The characters are clearly visible and legible. The text appears to be a code or identifier.
OMNI life science Apex Hip System Bipolar Head
| Submitter | OMNI life science, Inc.
50 O'Connell Way
E. Taunton MA 02718 |
|------------------|--------------------------------------------------------------------|
| Contact | Robert Zoletti
VP Regulatory Affairs
774-226-1845 |
| Preparation Date | April 8, 2010 |
MAY 2 8 2010
| Device Name | |
|---|---|
| Common Name | Hemi-hip prosthesis, uncemented |
| Trade Name | Apex Hip System Bipolar Head |
| Classification Name | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis |
| Orthopedic (OR) | |
| Regulatory Class | Class II per 21 CFR §888.3390 |
| Product Code | KWY |
| Legally Marketed | |
| Predicate Device(s) | Apex Hip System Bipolar Head |
| K 082468, K945793, K931655 | |
| Device Description | The Apex Hip System Bipolar Head consists of a factory assembled Ultra High |
| Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and | |
| UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer | |
| diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient | |
| anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates | |
| with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) | |
| have an inner diameter that mates with a 28 mm diameter femoral head. The Apex | |
| Hip System Bipolar Head may be used in conjunction with an Apex Hip System | |
| femoral stem (K060072) for hemiarthroplasty. | |
| Indications for Use | The indications have not changed from the predicate. The Apex Hip System Bipolar |
| Head is intended for use in combination with an Apex Hip System femoral stem for | |
| uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be | |
| used for the following conditions, as appropriate: | |
| Femoral neck and trochanteric fractures of the proximal femur;Osteonecrosis of the femoral head;Revision procedures where other devices or treatments for these indications have failed. | |
| Predicate Device | |
| Comparison | The Apex Hip System Bipolar Head is identical to the Apex Hip System Bipolar Head |
| cleared in K082468 with the following exceptions: | |
| The UHMWPE (ASTM F-648) retaining ring in the Acetabular component was modified to increase the amount of interference/overlap between the retaining ring and the head.A Retaining Spring (Ti-6Al-4V Eli) was added to the UHMWPE Retaining Ring. | |
| Non-Clinical Test | |
| Summary | The following tests were conducted: |
| Push-out and lever-out testing.Locking ring spring storage heat tolerance test (150°F).ETO sterilization validation, SAL 106 | |
| Clinical Test | |
| Summary | No clinical studies were performed. |
| Conclusions | The Apex Hip System Bipolar head is substantially equivalent to the predicate device. |
rage
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OMNI Life Science, Inc. % Mr. Robert Zoletti VP Regulatory Affairs 175 Paramount Drive Raynham, MA 02767
MAY 2 8 2010
Re: K100151
Trade/Device Name: Apex Hip System Bipolar Head Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented Regulatory Class: Class II Product Code: KWY Dated: May 21, 2010 Received: May 26, 2010
Dear Mr. Robert Zoletti:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 -Mr. Robert Zoletti
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CER.Part.803.), please go-to_
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K100151
Indications for Use
510(k) Number (if known): K100151
Device Name: Apex Hip System Bipolar Head
Indications For Use:
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- . Femoral neck and trochanteric fractures of the proximal femur;
- Osteonecrosis of the femoral head;
- Revision procedures where other devices or treatments for these indications have failed.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (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)
| for mxm | |
|---|---|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices |
Page 1 of 1510(k) Number K|0015/
OMNI BiPolar