(175 days)
Not Found
No
The device description and intended use are purely mechanical, describing a physical implant for hip replacement. There is no mention of software, algorithms, or data processing that would suggest AI/ML.
Yes
The device is intended for the treatment of conditions like fractures and osteonecrosis, indicating a therapeutic purpose.
No
Explanation: The device is an implantable medical device (bipolar head for hip arthroplasty), which is used for treatment rather than diagnosis. Its function is to replace or assist a hip joint, not to detect or identify a disease or condition.
No
The device description clearly states it is a physical implantable device made of materials like UHMVPE and cobalt chrome, intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Apex Hip System Bipolar Head is a prosthesis intended for surgical implantation in the hip joint. It is a physical component used to replace or augment a damaged part of the body.
- Intended Use: The intended use describes the conditions for which the prosthesis is used (fractures, osteonecrosis, revisions) and its function in a hemiarthroplasty procedure. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool.
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
KWY
Device Description
The Apex Hip System Bipolar Head consists of a factory assembled UHMVPE IIner in a coball chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the palient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bloolar heads (43 mm to 60 mm) have en inner diameter that mates with a 28 mm diameter temoral head. The Agex Hip System Bipolar Head may be used for hemiarthroplasty in conjunction with the following Apex Hip System femoral stems: Apox K1 ™ , Apex K2 ™ , and Apex Modular™
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for OMNIlife science. The logo consists of a circular symbol with a hole in the center, positioned above the text "OMNIlife science". The word "science" has a trademark symbol next to it.
FEB 1 8 2009
510(K) Summary
K 082468
Apex Hip System Bipolar Head
January 14, 2009
- OMNI life science, Inc. 1. Submitter: 175 Paramount Drive Raynham, MA 02787
- Contact: William McCallum Requiatory and Quality Systems (508) 824-2444 x413
2. Device Name
Proprietary Name: Apax Hip System Bipolar Head Common Name: Hemi-hip prosthesis, uncemented Classification Name: Hip joint femoral (hemi-hip) metalloolymer comented or uncemented prosthesis Regulatory Class: Class II per 21 CFR $888.3390
3. Intended 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 hemlarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- 争 Femoral neck and trochanteric fractures of the proximal femur:
- Osteonecrosis of the femoral head; 사
- Revision procedures where other devices or treatments for these indications have failed.
4. Device Description
The Apex Hip System Bipolar Head consists of a factory assembled UHMVPE IIner in a coball chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the palient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bloolar heads (43 mm to 60 mm) have en inner diameter that mates with a 28 mm diameter temoral head. The Agex Hip System Bipolar Head may be used for hemiarthroplasty in conjunction with the following Apex Hip System femoral stems: Apox K1 ™ , Apex K2 ™ , and Apex Modular™
Page 1 of 2
1
5. Predicate Device Comparison
Substantial equivalence is claimed to the Pivot Bipofar Femoral Head (KO50966) distributed by Ortho Development, the PLUS Bipciar Prosthesis (K982447) distributed by Plus Orthopaedics (now Smith & Nephew), and the BioPro Bipolar Head (K082705). The following table summarizes the similarities and differences between the Apex Hip System Bipolar Head and these predicate devices:
| | Apex Hip
System
Bipolar Head | Ortho
Development
Pivot Bipolar | Plus
Orthopedics
PLUS Bipolar | BioPro
Bipolar Head |
|------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 510(k)
Number | Pending | K050966 | K982447 | K082705 |
| FDA Product
Code | KWY | KWY | KWY | KWY |
| DESIGN | | | | |
| Liner-Shell | UHMWPE-
CoCr | UHMWPE-
CoCr | UHMWPE-
CoCr | UHMWPE
CoCr |
| Head Outer
Diameter | 38 to 60 mm in
1 mm
increments | 38 to 60 mm in
1 mm
increments | 43 to 60 mm in
1 mm
increments | 38 to 60 mm
in 1 mm
increments |
| Self-
aligning
(eccentric
head) | Yes | Yes | Yes | Yes |
| Liner Inner
Diameter | 22.225 or 28
mm | 22.225 or 28
mm | 28 mm | 22.225 or 28
mm |
| Liner-Head
Assembly | Head snap-fit
into bipolar liner | Head snap-fit
into bipolar liner | Head held in by
retention ring | Head snap-fit
into bipolar
liner |
| UHMWPE
retention
ring | Yes | Yes | Yes | Yes |
| MATERIALS | | | | |
| Femoral
head | CoCr or
alumina
ceramic | Cobalt
chromium
(CoCr) | Cobalt
chromium
(CoCr) | CoCr or
alumina
ceramic |
| Outer shell | Cobalt
chromium
(ASTM F75) | Cobalt
chromium
(ASTM F75) | Cobalt
chromium
(ASTM F75) | Cobalt
chromium
(ASTM F75) |
| Liner and
retention
ring | UHMWPE
(ASTM F648),
EtO sterilized
(not highly
crosslinked) | UHMWPE
(ASTM F648),
gamma
sterilized (not
highly
crosslinked) | UHMWPE
(ASTM F648),
EtO sterilized
(not highly
crosslinked) | UHMWPE
(ASTM
F648), EtO
sterilized (not
highly
crosslinked) |
Page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2009
OMNI Life Science, Inc. % Mr. William McCallum Director, Regulatory and Quality Systems 175 Paramount Drive Raynham, Massachusetts 02767
Re: K082468
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 prosthesis Regulatory Class: II Product Code: KWY
Dated: January 14, 2009 Received: January 15, 2009
Dear Mr. McCallum:
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 - Mr. William McCallum
Enclesure
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)); please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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4
Indications for Use
610(k) Number (if known): K082468
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 revilsion hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
. Femoral neck and tracteric fracteres of the proximal temur: చెన్ని
- Osteonecrosis of the femoral head;
- Revision procedures where other devices ar treatments for these indications have failed.
Presoription Use X (Per 21 CF61801 Subpart D)
ANDIOR
Over-The Counter Use, 23 CFR 801 Subpert 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, Restorativest and Neurological Devices
510(k) Number.