(193 days)
P960054, P960047, K021661
Not Found
No
The description focuses on the mechanical components and intended use of a constrained acetabular liner for hip arthroplasty. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies mentioned are mechanical tests and design comparisons, not studies related to algorithmic performance.
Yes
The device is intended for the treatment of high-risk hip dislocation in total hip arthroplasties.
No
The device is an acetabular liner for hip arthroplasties, which is an implant used in treatment, not for diagnosis.
No
The device description clearly states it consists of physical components (a liner and a ring) intended for surgical implantation in a total hip arthroplasty. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation in the hip to treat instability and reduce the risk of dislocation in total hip arthroplasty. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components (liner and ring) and how they are assembled and implanted. It does not mention any components or processes related to testing biological samples.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
This device is a medical device used in surgery, specifically a component for a total hip replacement.
N/A
Intended Use / Indications for Use
The Epsilon™ Durasul® Constrained Acetabular Liner is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.
Product codes (comma separated list FDA assigned to the subject device)
KWZ
Device Description
This device consists of two components: a liner and a ring, which will be assembled and attached to one of the corresponding Centerpulse Orthopedics Inc. acetabular shells. The liner mates with previously-cleared Centerpulse Orthopedics Inc. acetabular shell components via a snap lock mechanism. The metallic reinforcing ring provides added femoral head constraint once assembled. The fixation method of the acetabular components is porous cementless with supplemental screws, and the fixation method of the femoral components is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component. At the time of surgery, the constrained liner and ring will be assembled to the corresponding acetabular shell and femoral head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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 Epsilon™ Durasul® Constrained Acetabular Liner demonstrate that this device is substantially equivalent to the predicate device.
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.
P960054, P960047, K021661
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
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
KO30923
OCT - 3 2003
510(k) SUMMARY
| SPONSOR NAME: | Centerpulse Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth
Phone: (512) 432-9324
Robert.Wolfarth@Centerpulse.com |
| TRADE NAME: | Epsilon™ Durasul® Constrained Acetabular Liner |
| COMMON NAME: | Constrained Acetabular Insert |
| CLASSIFICATION: | Constrained Acetabular Inserts (87 KWZ) are Class II per 21 CFR
§888.3310, reviewed by the Orthopedic Devices panel. |
PREDICATE DEVICES:
- Johnson & Johnson DePuy S-ROM Poly-Dial Constrained Liner (P960054) ●
- Stryker/Howmedica/Osteonics Omnifit Constrained Liner (P960047) .
- . Biomet Ringloc Constrained Liner (K021661)
DEVICE DESCRIPTION:
This device consists of two components: a liner and a ring, which will be assembled and attached to one of the corresponding Centerpulse Orthopedics Inc. acetabular shells. The liner mates with previously-cleared Centerpulse Orthopedics Inc. acetabular shell components via a snap lock mechanism. The metallic reinforcing ring provides added femoral head constraint once assembled. The fixation method of the acetabular components is porous cementless with supplemental screws, and the fixation method of the femoral components is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component. At the time of surgery, the constrained liner and ring will be assembled to the corresponding acetabular shell and femoral head.
INTENDED USE:
The Epsilon™ Durasul® Constrained Acetabular Liner is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance tests, design comparisons, and functional analyses conducted on the Epsilon™ Durasul® Constrained Acetabular Liner demonstrate that this device is substantially equivalent to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design featuring three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 2003
Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K030923
Trade Name: Epsilon™ Durasul® Constrained Acetabular Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: July 7, 2003 Received: July 9, 2003
Dear Mr. Wolfarth:
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.
2
Page 2 - Mr. Robert M. Wolfarth
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 (301) 594-4659. 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 vours,
Mali McMillan
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
长030923 510(K) Number:
Device Name:
Epsilon™ Durasul® Constrained Acetabular Insert
Indications for Use:
The Epsilon™ Durasul® Constrained Acetabular Insert is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
- Restorative al Devices
510(k) Number K030923