(15 days)
The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® II X3® Polyethylene bearing inserts, which are also the subject of this submission. If additional fixation is desired, the dome screw holes, if present, have . been designed to accept Howmedica Osteonics 6.5mm or 5.5mm bone screws.
The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation with the mating Trident® II X36 Polyethylene Inserts.
Indications for Use:
- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- · Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
This Special 510(k) submission is intended to add the Trident® II Acetabular System. This system is a minor modification to the locking mechanism of the predicate Trident Acetabular System.
Here's an analysis of the provided text regarding the Trident® II Acetabular System, focusing on the acceptance criteria and the study proving it:
Acceptance Criteria and Device Performance for Trident® II Acetabular System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Comparable mechanical properties to predicate device | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
| Material | Same as predicate device | Shares the same materials as the currently available acetabular components of the Trident® Acetabular System. |
| Design Concept | Basic design concepts same as predicate device | Shares the same basic design concepts as that of the currently available acetabular components of the Trident® Acetabular System. |
| Intended Use | Same as predicate device | Shares the same intended use as that of the currently available acetabular components of the Trident® Acetabular System. |
| Substantial Equivalence | Demonstrates substantial equivalence to predicate device based on mechanical properties and design. | Mechanical testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices. |
2. Sample Size and Data Provenance:
The document does not provide details on specific sample sizes for the mechanical testing. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, the study involved mechanical testing of the device, implying laboratory-based data rather than patient data.
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention the use of experts to establish ground truth. The evaluation of the device was based on mechanical testing and comparison to a predicate device, not on expert interpretations of clinical data or images.
4. Adjudication Method:
Adjudication methods (e.g., 2+1, 3+1, none) are relevant for studies involving human interpretation or clinical outcomes. This submission focuses on engineering analysis and comparison to a predicate device, so an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of a device (often AI-assisted) on human reader performance, which doesn't apply to a mechanical implant like an acetabular system.
6. Standalone (Algorithm Only) Performance:
No standalone (algorithm only) performance study was done. This refers to the performance of an AI algorithm without human intervention, which is not relevant to a mechanical hip implant.
7. Type of Ground Truth Used:
The ground truth for this device's acceptance was:
- Mechanical Test Results: The measured mechanical properties of the Trident® II Acetabular System itself.
- Predicate Device Specifications/Performance: The established mechanical properties, materials, and design concepts of the legally marketed predicate Trident Acetabular System.
Essentially, the device's performance was compared directly to engineering standards and a pre-existing, approved device.
8. Sample Size for the Training Set:
There is no mention of a "training set" because this is a medical device, not an AI or machine learning model. The evaluation is based on mechanical testing and comparison.
9. How Ground Truth for the Training Set Was Established:
As there is no training set mentioned or relevant for this type of device submission, this question is not applicable.
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K0636/6
Summary of Safety and Effectiveness Trident® II Acetabular System
DEC 2 0 2006
Proprietary Name:
Common Name:
Classification Name:
Regulation Number:
Device Product Code:
For Information Contact:
Trident® II Acetabular System
Artificial Hip Replacement Components -Acetabular
Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis
21 CFR §888.3353
LZO, MEH
Manal Morcos, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5020 Fax: (201) 831-6038
Date Summary Prepared:
October 10, 2006
Description:
This Special 510(k) submission is intended to add the Trident® II Acetabular System. This system is a minor modification to the locking mechanism of the predicate Trident Acetabular System.
Intended Use:
The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation within the prepared acetabulum. They are compatible with Trident® II X3® Polyethylene bearing inserts, which are also the subject of this submission. If additional fixation is desired, the dome screw holes, if present, have . been designed to accept Howmedica Osteonics 6.5mm or 5.5mm bone screws.
The Trident® II Acetabular Shells described in this 510(k) submission are single-use sterile devices intended for cementless fixation with the mating Trident® II X36 Polyethylene Inserts.
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Indications for Use:
- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- · Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Substantial Equivalence:
The subject Trident® II Acetabular System shares the same intended use, materials, and basic design concepts as that of the currently available acetabular components of the Trident® Acetabular System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices.
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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 features a stylized eagle-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Mr. Manal Morcos Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430
DEC 2 0 2006
Re: K063616
Trade/Device Name: Trident® II Acetabular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: December 4, 2006 Received: December 5, 2006
Dear Mr. Morcos:
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.
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Page 2 - Mr. Manal Morcos
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,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Trident® II Acetabular System
The subject Trident® II Acetabular Shells are intended for cementless fixation within the prepared acetabulum. The subject Acetabular shells intended for use with mating Trident® II X3® Polyethylene Inserts.
Indications for Use:
- · Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- · Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- · Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum,
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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 (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
120123616 510(k) Number_
N/A