(89 days)
Not Found
No
The document describes a physical medical device (acetabular inserts) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to relieve pain and restriction of motion associated with painful disabling joint disease of the hip, which aligns with the definition of a therapeutic device.
No
The device description indicates that the Trident® Large Diameter Acetabular Inserts are replacement parts for the hip joint, used in total hip arthroplasty to relieve pain and improve motion. Its purpose is to physically replace anatomical structures, not to diagnose conditions.
No
The device description clearly states it is a physical implant made of Ultra High Molecular Weight polyethylene, intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text clearly describes a physical implantable device (acetabular inserts made of polyethylene) intended for surgical implantation into the hip joint to replace damaged surfaces. This is an in vivo (within the body) device, not an in vitro diagnostic test.
- Lack of Diagnostic Testing: The intended use and device description do not mention any form of testing on biological samples or providing diagnostic information. The device's purpose is mechanical replacement and restoration of function.
N/A
Intended Use / Indications for Use
Intended Use: The Trident® Large Diameter Acetabular Inserts are intended for the replacement of the bearing and articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.
These subject devices are provided sterile and designed for single use only, and are intended for use in patients indicated for total hip arthroplasty. The components may be used for primary and revision applications.
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 proposed acetabular inserts are Ultra High Molecular Weight polyethylene devices that range thickness from 3.8mm to 12.6mm measured at 34° from the axis of symmetry. The subject inserts include Trident® Large Diameter acetabular inserts, which will be available in 40mm and 44mm inner diameter (ID), and accommodate Howmedica Osteonics' 40mm and 44mm cobalt chrome femoral heads (K061434). The sizes 28 through 36 inner diameter inserts accommodate previously cleared Howmedica Osteonics' 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, acetabulum
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.
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
Image /page/0/Picture/0 description: The image contains the words "K062419", "stryker", "Howmedical", and "OSTEONICS". There is also a handwritten "1/2" in the upper right corner of the image. The words "stryker", "Howmedical", and "OSTEONICS" are stacked on top of each other.
325 Corporate Drive Mahwah, NJ USA 07430
510(k) Summary of Safety and Effectiveness for the Trident® Large Diameter Acetabular Inserts
NUV 15 2006
| Proprietary Name: | Trident® Large Diameter Acetabular Inserts |
|---|---|
| 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
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 August 17, 2006
Date Summary Prepared:
Device Description
The proposed acetabular inserts are Ultra High Molecular Weight polyethylene devices that range thickness from 3.8mm to 12.6mm measured at 34° from the axis of symmetry. The subject inserts include Trident® Large Diameter acetabular inserts, which will be available in 40mm and 44mm inner diameter (ID), and accommodate Howmedica Osteonics' 40mm and 44mm cobalt chrome femoral heads (K061434). The sizes 28 through 36 inner diameter inserts accommodate previously cleared Howmedica Osteonics' femoral heads. The polyethylene liners are compatible with the Trident® line of acetabular shells.
Intended Use:
The Trident® Large Diameter Acetabular Inserts are intended for the replacement of the bearing and articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.
These subject devices are provided sterile and designed for single use only, and are intended for use in patients indicated for total hip arthroplasty. The components may be used for primary and revision applications.
Indications for Use
- 피 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 트 procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are 트 less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as F indicated by deficiencies in the acetabulum.
Substantial Equivalence:
The Trident® large diameter acetabular inserts are substantially equivalent to Howmedica Osteonics' Trident® Acetabular Inserts, K033716 and Inter-Op Durasul Acetabulan System cleared by Sulzer Orthopaedics, K002575.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
NOV 15 2006
Re: K062419
Trade/Device Name: Trident® Large Diameter Acetabular Inserts Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: LPH, JDI, LZO, MEH Dated: August 17, 2006 Received: August 18, 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,
for Rob
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): 1662419
Device Name: Trident® Large Diameter Acetabular Inserts
Indications for Use
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid 매 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 피 less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as 트 indicated by deficiencies in the acetabulum.
Prescription Use
OR Over-the-Counter Use -------(Per 21 CFR 801.109)
Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.O. Runa
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
11962919 510(k) Number