(90 days)
No
The 510(k) summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a prosthesis intended for arthroplasty of the hip, which is a medical procedure to treat conditions like fractures and osteonecrosis, thus serving a therapeutic purpose.
No
The device, BioPro Bipolar Head, is a prosthetic implant used in hip arthroplasty, not a device designed to diagnose medical conditions. Its intended use is to replace components of the hip joint.
No
The device description clearly indicates it is a physical implantable device made of UHMWPE and cobalt chrome, intended for hip arthroplasty. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that the BioPro Bipolar Head is a prosthesis intended for surgical implantation in the hip joint. It is a physical device used to replace or support a damaged anatomical structure.
- Intended Use: The intended use describes the conditions for which the prosthesis is used in hip arthroplasty (hip replacement surgery). This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a medical device, specifically an implantable orthopedic device, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The BioPro Bipolar Head is intended for use in combination with a BioPro femoral stem for uncemented primary or revision arthroplasty 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 BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt 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 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 with a == iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, proximal femur, femoral head
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
KOB2705 (pg1/2)
510K Summary
DEC 1 5 2008
BioPro Bipolar Head
August 25, 2008
BioPro, Inc. 17 17th Street Port Huron, MI 48060
Contact: David Mrak Director of Product Dev. (810) 982-7777
2. Device Name
- Submitter:
BioPro Bipolar Head Proprietary Name: Hip prosthesis, uncemented Common Name: Hip joint femoral metal/polymer cemented or uncemented Classification Name: prosthesis Class II per 21 CFR §888.3390 Requlatory Class:
3. Intended Use
The BioPro Bipolar Head is intended for use in combination with a BioPro femoral stem for uncemented primary or revision arthroplasty 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.
4. Device Description
The BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt 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 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 with a == iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.
1
5. Predicate Device Comparison
Substantial equivalence is claimed to the Pivot Bipolar Femoral Head (1882146) Substantial equivalorio is claimot to the PLUS Bipolar Prosthesis (K982447) distributed by Ortho Dovelopment and Smith & Nephew). The following table distributed by Tus Orthopadules (non-Shiken the BioPro Bipolar Head and these predicate devices:
| | BioProBipolar
Head | Ortho
Development Pivot
Bipolar Head | Plus Orthopedics
PLUS Bipolar
Prosthesis |
|-----------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k) Number | Pending | K050966 | K982447 |
| FDA Product Code | KWY | KWY | KWY |
| DESIGN | | | |
| Head-Liner-Shell | CoCr-UHMWPE-
CoCr | CoCr-UHMWPE-
CoCr | 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 |
| Self-aligning
(eccentric head) | Yes | Yes | Yes |
| Liner Inner Diameter | 22.225 or 28 mm | 22.225 or 28 mm | 28 mm |
| Liner-Head
Assembly | Head snap-fit into
bipolar liner | Head snap-fit into
bipolar liner | Head held in by
retention ring |
| UHMWPE retention
ring | Yes | Yes | Yes |
| MATERIALS | | | |
| Outer shell | 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) |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Public Health Service
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
BioPro, Inc. % Mr. David Mrak Director of Product Development 17 Seventeenth St. Port Huron, Michigan 48060
DEC 1 5 2008
Re: K082705
Trade/Device Name: BioPro Bipolar Head, Models 18130 - 18152 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: August 15, 2008 Received: September 16, 2008
Dear Mr. Mrak:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed for we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 to sund in the encreation of the enactment date of the Medical Device Amendments, or to Conninered phor to May 20, 1976, Lie accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Free) that to her ice, subject to the general controls provisions of the Act. The r ou may, ulciclore, thanker and act include requirements for annual registration, listing of general controls provisions of the rise, 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 If your device is classified the world . Existing major regulations affecting your device can thay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Court of I courts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDF is issualles or on device complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of any I cucha statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), idocimig (21 CFR Part 820); and if applicable, the electronic for the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. David Mrak
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 Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KD827056pg1/1) 510(k) Number (if known):
Device Name: BioPro Bipolar Head
Indications for Use:
The BioPro Bipolar Head is intended for use in combination with a BioPro PSL Hip System femoral stem for uncemented primary or revision arthroplasty 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 (Per 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)
Niel R.P. Oden for
Page 1 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
s