(24 days)
Not Found
No
The summary describes a mechanical implant with modifications to its geometry and fixation method, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a component of a total hip prosthesis, which is used to replace a diseased or damaged hip joint and restore its function, thus treating a medical condition.
No
The device is an implantable component of a total hip prosthesis, used to stabilize the hip joint in patients at high risk of dislocation. It does not perform any diagnostic function.
No
The device description clearly describes a physical implant (acetabular insert) made of materials like titanium alloy and polymer, intended for surgical implantation. It discusses modifications to the physical geometry and fixation method, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant – a component of a total hip prosthesis. It is designed to be surgically placed within the body.
- Intended Use: The intended use is to be a component of a total hip prosthesis for patients at high risk of hip dislocation. This is a therapeutic and structural function, not a diagnostic one performed on a specimen outside the body.
Therefore, based on the description and intended use, the Trident® Constrained Acetabular Insert is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Product codes (comma separated list FDA assigned to the subject device)
87 KWZ
Device Description
The Trident® Constrained Acetabular Insert is a specific insert designed to accept a Stryker UHR® bipolar head. The bipolar head is preassembled to the insert and securely retained by a titanium alloy retaining ring. This submission details two separate modifications to the predicate Trident Constrained Acetabular Insert. The first modification is described as the subject Trident® 0° Constrained Acetabular Insert. The subject Trident® 0° Constrained Acetabular Insert has a neutral (0°) face instead of the 10° face on the predicate Trident® Constrained Acetabular Insert. The second modification is described as the subject Trident® All-Poly Constrained Acetabular Insert. The subject Trident® All-Poly Constrained Acetabular Insert has a neutral (0°) face instead of the 10° face on the predicate Trident® Const Acetabular Insert and a modified external geometry to allow for cement fixation.
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)
Mechanical testing and analysis demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength.
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
§ 888.3310 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
Line Extension to the Trident Constrained Acetabular Insert
K06165 1 of 2)
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Trident® Constrained Acetabular Insert
JUL - 7 2006
| Proprietary Name: | Trident® Constrained Acetabular Insert |
|---|---|
| Common Name: | Constrained Hip Prosthesis |
| Proposed Regulatory Class: | Class II |
| Classification: | 21 CFR § 888.3310 - Prosthesis, Hip, Constrained, Cemented or |
| Uncemented, Metal/ Polymer | |
| Device Product Code: | 87 KWZ |
| For Information contact: | Joseph Viola |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Telephone: (201) 831-5379 | |
| Fax: (201) 831-6038 |
Email: joseph.viola@stryker.com
May 15, 2006 Date Summary Prepared:
1
Special 510(k) Premarket Notification
Device Description
The Trident® Constrained Acetabular Insert is a specific insert designed to accept a Stryker UHR® bipolar head. The bipolar head is preassembled to the insert and securely retained by a titanium alloy retaining ring. This submission details two separate modifications to the predicate Trident Constrained Acetabular Insert. The first modification is described as the subject Trident® 0° Constrained Acetabular Insert. The subject Trident® 0° Constrained Acetabular Insert has a neutral (0°) face instead of the 10° face on the predicate Trident® Constrained Acetabular Insert. The second modification is described as the subject Trident® All-Poly Constrained Acetabular Insert. The subject Trident® All-Poly Constrained Acetabular Insert has a neutral (0°) face instead of the 10° face on the predicate Trident® Constrained Acetabular Insert and a modified external geometry to allow for cement fixation.
Indications for Use
The Trident® Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Substantial Equivalence
The features of the subject components are substantially equivalent to the predicate devices, the Trident® 10° Constrained Acetabular Insert (P960047), the Howmedica Osteonics Contemporary Cup (K982670) and the Biomet Freedom™ Constrained Acetabular Insert (K030047), based on similarities in intended use, materials and design. Mechanical testing and analysis demonstrates substantial equivalence of the subject components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate Trident® insert and subject components are identical.
ﻟﺪ
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2006
Howmedica Osteonics Corp. c/o Mr. Joseph Viola Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K061654 Trade/Device Name: Trident® Constrained Acetabular Insert Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: May 15, 2006 Received: June 13, 2006
Dear Mr. Viola:
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 for associoior 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 r ou may , atests 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. Joseph Viola
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Вашазе Вневно
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K061654 510(k) Number (if known):
Device Name: Trident® Constrained Acetabular Insert
Indications For Use:
- The Trident® Constrained Acetabular Insert is intended for use as a component of a total . hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
Prescription Use
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amlan Bhund
AND/OR
Restorativ Division of Gene and Neurological Devices
510(k) Number K061654