(90 days)
Not Found
No
The document describes a mechanical implant (femoral heads and acetabular components) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an implant used in hip replacement procedures for various painful disabling joint diseases, which falls under the definition of a therapeutic device.
No
The device is a component of a hip replacement system, specifically a femoral head and acetabular component, intended for mechanical fixation and use in hip arthroplasty procedures. It is a therapeutic device, not one that diagnoses conditions.
No
The device description clearly describes physical components (femoral heads, acetabular components, polyethylene liners) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
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 device for mechanical fixation in hip arthroplasty procedures. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details physical components (femoral heads, acetabular components, polyethylene liners) designed for surgical implantation.
- Anatomical Site: The device is used in the Hip, which is an anatomical location within the body, not a specimen taken from the body.
IVD devices are typically used in laboratories or point-of-care settings to analyze samples like blood, urine, tissue, etc., to provide diagnostic information. This device is a surgical implant used to replace a joint.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
87 LZO, 87 LPH, 87 MEH, 87 JDI
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.
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)
Not Found
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.
K021310, K022077, K993259, K033716
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
§ 888.3358 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.
0
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 Uncemented | |
| Prosthesis | |
| 21 CFR §888.3350 | |
| Hip joint metal/polymer/metal semi-constrained | |
| porous-coated uncemented prosthesis | |
| 21 CFR §888.3358 | |
| Hip joint metal/ceramic/polymer semi-constrained | |
| cemented or nonporous uncemented prosthesis | |
| 21 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, Porous | |
| Coated, 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.
2
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.
3
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
4
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