(137 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device functions as a replacement for the femoral head in hip hemi-arthroplasty to treat specific diagnostic indications such as displaced femoral neck fractures, avascular necrosis, and non-union of femoral neck fractures. Its purpose is to restore the function of the natural femoral head.
No
The provided text describes the Durasul Bipolar as a device intended for surgical implantation in hip hemi-arthroplasty to replace the femoral head. While it mentions "Specific diagnostic indications for use of a bipolar," these are conditions for which the device is used, not what the device does diagnostically. The device itself is an implantable prosthetic, not a tool for diagnosing medical conditions.
No
The device description clearly states it consists of physical components (polyethylene insert/liner and an outer CoCr shell) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for a hip hemi-arthroplasty, replacing the function of the natural femoral head. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of a prosthetic hip joint (polyethylene insert, CoCr shell). This aligns with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is a therapeutic device used in surgery to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.
Product codes (comma separated list FDA assigned to the subject device)
KWY
Device Description
The Durasul Bipolar consists of a polyethylene insert/liner and an outer CoCr shell. In vivo, the CoCr shell articulates directly with well-preserved articular cartilage while the Durasul insert articulates directly with a 22 or 26mm femoral head. The Durasul Bipolar components are available in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a hip hemi-arthroplasty.
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)
Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices.
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
KD40947
AUG 2 7 2004
510(k) SUMMARY
| SPONSOR NAME: | Zimmer
9900 Spectrum Drive
Austin, TX 78717 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Audrey Swearingen
Phone: (512) 432-9255
Audrey.Swearingen@Zimmer.com |
| TRADE NAME: | Durasul® Bipolar |
| COMMON NAME: | Hemi-Hip |
| CLASSIFICATION: | Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or
Uncemented Prosthesis (87 KWY) are Class II per 21 CFR
§888.3390. |
PREDICATE DEVICES:
- Centerpulse Orthopedics, Inc. Bipolar (K873815) and .
- Exactech's AcuMatch L-Series Bipolar (K013211). .
DEVICE DESCRIPTION:
The Durasul Bipolar consists of a polyethylene insert/liner and an outer CoCr shell. In vivo, the CoCr shell articulates directly with well-preserved articular cartilage while the Durasul insert articulates directly with a 22 or 26mm femoral head. The Durasul Bipolar components are available in a variety of sizes to allow the surgeon to replicate the natural anatomy of the hip joint as closely as possible when performing a hip hemi-arthroplasty.
INTENDED USE:
The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests, design comparisons, and functional analyses conducted on the Durasul Bipolar demonstrate that this device is substantially equivalent to the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 2004
Ms. Audrey Swearingen Manager, Regulatory Affairs Zimmer Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K040947 Trade/Device Name: Durasul® Bipolar 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 6, 2004 Received: August 9, 2004
Dear Ms. Swearingen:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to that 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices that have been rouire approval of a premarket approval application (PMA). and Costiere Act (110.) that to nevice, subject to the general controls provisions of the Act. The I ou may, therefore, mans. of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 n your device is elassinod (tional controls. Existing major regulations affecting your device can may oc subject to back acceral 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 r lease oc devilod that I Dr o last is to the complies with other requirements of the Act that I Dr Has Intacted 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 Orth 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.
2
Page 2 - Ms. Audrey Swearingen
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to ogin mailing of substantial equivalence of your device to a legally premarket notheation: "The PDF mining of dassification 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 If you desire specific advice for your ac (301) 594-4659. Also, please note the regulation entitled, Colliation of Gollippiante in (Set notification" (21CFR Part 807.97). You may obtain Misoranung Uy Telefone to premainter to premainter the Act from the Division of Small other general 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 A. Melleson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K040947
Device Name: Durasul® Bipolar
Indications for Use:
The Durasul Bipolar is intended for non-cemented use in a hip hemi-arthroplasty in which it assumes the function of the natural femoral head in conjunction with a prosthetic femoral head component. Specific diagnostic indications for use of a bipolar include displaced femoral neck fractures, avascular necrosis of the femoral head, and non-union of femoral neck fractures.
X Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation for ODE)
Mark A Mulkeren
Division of General, Restorative, and Neurological Devices
Page 1 of 1
K040947 510(k) Number_________________________________________________________________________________________________________________________________________________________________