(90 days)
The subject devices are sterile, single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.
- 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 is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
The LFIT Cobalt Chrome femoral head product line will now be available with large diameter femoral heads and acetabular components that accommodate the larger diameters. The LFIT femoral heads will be offered in 36mm, 40mm, and 44mm diameters. The larger diameter femoral heads are compatible with Howmedica Osteonics V-40® and C-taper® hip stems.
The Trident® acetabular system will offer polyethylene liners able to accommodate 40mm and 44mm diameter femoral heads. The polyethylene liners are compatible with the Trident® line of acetabular shells.
The provided text is a 510(k) summary for the Trident® Hip System. This document outlines the regulatory submission for a medical device (hip prosthesis) and focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with specific acceptance criteria, device performance metrics, or details about a training/test set, expert ground truth, or MRMC studies.
Therefore, most of the information requested in your prompt cannot be extracted from this document as it does not contain details of an AI/algorithm performance study.
However, I can provide what information is available:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of an algorithm's performance, nor does it report device performance in terms of metrics like sensitivity, specificity, accuracy, etc., which would be typical for an AI-enabled device. The "acceptance" in this context refers to regulatory acceptance based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a medical device (hip prosthesis), not an AI algorithm evaluated with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for an AI algorithm is not established in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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K 661434 1 ×2
AUG 2 2 2006
Image /page/0/Picture/2 description: The image shows the logos for Stryker Howmedica Osteonics. The Stryker logo is in bold, sans-serif font and is located at the top left of the image. Below Stryker is the Howmedica logo, which is also in bold, sans-serif font. Below Howmedica is the Osteonics logo, which is in a thinner, sans-serif font. There is a horizontal line below the Osteonics logo.
325 Corporate Drive
Mahwah, NJ USA 07430
510(k) Summary of Safety and Effectiveness for the Trident® Hip System
| Proprietary Name: | Trident® Hip System |
|---|---|
| Common Name: | Hip Prosthesis |
| Classification Name and Reference | Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Nonporous UncementedProsthesis21 CFR §888.3350 |
| Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis21 CFR §888.3358 | |
| Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis21 CFR §888.3353 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 LZO - Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cemented or Non-Porous,Uncemented |
| 87 LPH - Prosthesis Hip, Semi-Constrained, PorousCoated, Uncemented | |
| 87 MEH - Prosthesis, hip, semi-constrained,uncemented, metal/polymer, non-porous, calicum-phosphate | |
| 87 JDI - Prosthesis, hip, semi-constrained,metal/polymer, cemented |
{1}------------------------------------------------
K061434 2012
| For Information contact: | Tiffani Rogers |
|---|---|
| Regulatory Affairs Specialist | |
| Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07432 | |
| Phone: (201) 831-5412 | |
| Fax: (201) 831-6038 | |
| E-Mail: Tiffani.Rogers@stryker.com | |
| Date Summary Prepared: | May 22, 2006 |
Device Description
The LFIT Cobalt Chrome femoral head product line will now be available with large diameter femoral heads and acetabular components that accommodate the larger diameters. The LFIT femoral heads will be offered in 36mm, 40mm, and 44mm diameters. The larger diameter femoral heads are compatible with Howmedica Osteonics V-40® and C-taper® hip stems.
The Trident® acetabular system will offer polyethylene liners able to accommodate 40mm and 44mm diameter femoral heads. The polyethylene liners are compatible with the Trident® line of acetabular shells.
Intended Use:
The subject devices are sterile, single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.
Indications for Use
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid 트 arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other 제 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 is inadequate for other reconstructive techniques as I indicated by deficiencies in the acetabulum.
Substantial Equivalence:
The LFIT femoral heads and Trident® large diameter acetabular inserts are substantially equivalent to Howmedica Osteonics' LFIT cobalt chrome femoral heads, K021310 and K022077, Inter-Op Durasul Acetabular System cleared by Sulzer Orthopaedics, K993259, and Howmedica Osteonics' Trident® acetabular system, K033716.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2006
Howmedica Osteonics Corp % Ms.Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K061434
Trade/Device Name: Trident™ Large Diameter Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, JDI, MEH Dated: May 22, 2006 Received: May 24, 2006
Dear Ms. Rogers:
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 - Ms.Tiffani Rogers
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,
Barbara Buchind
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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111 Ko 61434
510(k) Number (if known):
Device Name: Trident® Large Diameter Hip System
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 트 less likely to achieve satisfactory results,
- ICSS Incl. 10 demore sailbrery researly researly, we seconstructive techniques as 트 indicated by deficiencies in the acetabulum.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR Over-the-Counter Use (Per 21 CFR 801.109)
21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara BrienD
Division of General, Restorative, and Neurological Devices
510(k) Number K061434
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.