(104 days)
Not Found
Not Found
No
The document describes a mechanical implant (acetabular liners) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a component of a total hip prosthesis used in the replacement of body parts due to degenerative joint disease, trauma, or failed previous prostheses, and to address chronic dislocation, which are all therapeutic functions.
No
Explanation: The device is a constrained acetabular liner intended as a component of a total hip prosthesis for treating hip dislocations. It is an implantable device used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "line extension intended to add Series II Constrained Acetabular Liners to the Series II Hip System," indicating it is a physical implant component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace parts of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description confirms it's a component of a hip replacement system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
The Series II Constrained Acetabular Liners are intended to be used with the various components of the Series II Hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
Product codes
87 KWZ, KWZ
Device Description
This 510(k) submission is a line extension intended to add Series II Constrained Acetabular Liners to the Series II Hip System.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K063552 (pg 1 of 2)
Summary of Safety and Effectiveness Series II Constrained Acetabular Liners
| Proprietary Name: | Series II Constrained Acetabular Liners |
|---|---|
| Common Name: | Artificial Hip Acetabular Component |
| Classification Name and Reference | Hip joint metal/polymer constrained |
| cemented or uncemented prosthesis, | |
| 21 CFR §888.3310 | |
| Device Product Code: | 87 KWZ |
| For Information contact: | Francisco Haro, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5493 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | November 21, 2006 |
Description:
This 510(k) submission is a line extension intended to add Series II Constrained Acetabular Liners to the Series II Hip System.
Intended Use:
The Series II Constrained Acetabular Liners are intended to be used with the various components of the Series II Hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.
Indications for Use:
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
1
K063552 (pg2 of 2)
Substantial Equivalence:
The subject Series II Constrained Acetabular Liners share intended use, design concepts, and demonstrated comparable mechanical properties to the predicate components and are substantially equivalent to these devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corporation c/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
MAR 0 8 2007
Re: K063552
Trade/Device Name: Series II Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: February 16, 2007 Received: February 20, 2007
Dear Mr. Haro:
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. Francisco Haro
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Milliman
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
510(k) Number (if known): / 063552
Device Name: Series II Constrained Acetabular Liners
Indications for Use:
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
Over-The-Counter Use Prescription Use _ X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K063552