(442 days)
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Not Found
No
The document describes a mechanical implant (hip system components) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on material properties and mechanical testing.
Yes
The device is intended to treat painful, disabling joint disease of the hip, relieve pain, instability, and restriction of motion, and replace the bearing surface of the acetabulum, all of which align with the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
This device, the Trident® Acetabular Hip System Polyethylene inserts, is described as a component for total hip arthroplasty, used for replacement of the bearing surface to relieve pain and improve motion. Its function is to treat a condition, not to diagnose it.
No
The device description clearly indicates it is a physical component (acetabular inserts) of a total hip system, not software.
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 surgical implant for replacing a joint surface in the hip. This is a therapeutic device, not a diagnostic one.
- Device Description: The description reinforces that the device is a component of a total hip system used for surgical replacement.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical properties, wear, and material characteristics, which are relevant to the function of a surgical implant, not a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnostic purposes. This device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Hip System components are for use in total hip arthroplasty to relieve pain and restore function for indications such as: painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis; revision of previous failed 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.
Product codes (comma separated list FDA assigned to the subject device)
87 JDI, 87 LPH, 87 LWJ, 87 LZO, 87 MEH
Device Description
The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes material properties testing; wear testing; the effect of sterilization on the sequentially crosslinked and annealed material; dimensional assessment of the sequentially crosslinked and annealed material; disassembly force evaluation; and contact stresses.
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.
Trident® Hip System
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
K033716 FEB 1 0 2005
Summary of Safety and Effectiveness
| Contact Person: | Karen Ariemma
Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
(201) 831-5718 (Phone)
(201) 831-6038 (FAX) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 3, 2005 |
| Device: | Trident® Hip System |
| Classification: | Prosthesis Hip, 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 |
| | Hip Joint Metal/Polymer Semi-Constrained Cemented
Prosthesis, 21 CFR 888.3350 |
| Device Product Codes: | 87 JDI, 87 LPH, 87 LWJ, 87 LZO, 87 MEH: |
| Predicate Devices: | Trident® Hip System |
| Indications for Use: | The Trident® Acetabular Hip System Polyethylene inserts
are intended for use with the mating Trident Acetabular
Shells. The Trident Acetabular Shells are intended for
cementless fixation. The Trident® Hip System components
are for use in total hip arthroplasty to relieve pain and
restore function for indications such as: painful, disabling
joint disease of the hip resulting from: non-inflammatory
degenerative arthritis, rheumatoid arthritis, post-traumatic
arthritis, or late stage avascular necrosis; revision of
previous failed 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. |
1
| Proposed Modification: | Addition of new polyethylene components of a modified
sequentially crosslinked and annealed material which has
undergone a STERRAD gas plasma sterilization. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The device includes the acetabular inserts of a total hip
system. These components are used for the replacement of
the bearing surface of the acetabulum to relieve pain,
instability and the restriction of motion due to degenerative
bone disease, including osteoarthritis, rheumatoid arthritis,
failure of other devices or trauma. |
| Summary of Data: | A risk analysis and research and development testing have
been performed to demonstrate equivalence of the proposed
products to the predicate devices. The testing includes
material properties testing; wear testing; the effect of
sterilization on the sequentially crosslinked and annealed
material; dimensional assessment of the sequentially
crosslinked and annealed material; disassembly force
evaluation; and contact stresses. |
:
: 上一篇:
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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 2005
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K033716
Trade/Device Name: Trident® Hip System Trade/Device Name: "Thuene" Thp 3558:21 CFR 888.3353 and 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Hip joint metal/ceramic/polymer semiancetrained cemented or nonporous uncemented prosthesis,Hip joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: II Product Code: LPH, LZO, JDI, MEH and LWJ Dated: December 14, 2004 Received: December 15, 2004
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed four becalent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreases in the enactment date of the Medical Device Amendments, or to commerce prior to rias 2011-12-11 in accordance with the provisions of the Federal Food, Drug, devices mark nave occh recident a newee 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, mereleve, mains of the Act include requirements for annual registration, listing of general voltrols pro reserving 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 If your device is olassinod (600 a00 10) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least of advised that i Dr brisean that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must
3
Page 2 - Ms. Karen Ariemma
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 CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter with anow you to ough mailing of substantial equivalence of your device to a legally premarket notification. The FDA mianing of castion 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 11 you desire specific advice for Jour do 100-276-0120. Also, please note the regulation entitled, Connact the Office of Collier of Colliention" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours
Martin M. Wilkerson
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K033716
Device Name: Trident Hip System - Polyethylene Inserts
Indications For Use:
The Trident® Acetabular Hip System Polyethylene inserts are intended for use with the mating Trident® Acetabular Shells. The Trident® Acetabular Shells are intended for cementless fixation. The Trident® Acetabular Hip System Polyethylene inserts are indicated for use in total hip arthroplasty in the following instances:
- Painful, disabling joint disease of the hip resulting from: non-inflammatory . degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- Revision of previous failed 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
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
f
Concurrence of CDRH Office of Device Evaluation (ODE)
Met
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K033716