(63 days)
Not Found
No
The description focuses on patient-specific design and manufacturing based on anatomy, without mentioning AI/ML for analysis, planning, or other functions. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is used for total hip arthroplasty to resurface the acetabular socket, rehabilitating damaged hips due to disease, deformity, or trauma. This directly treats a medical condition and restores function.
No
The device is an implant for resurfacing the acetabular socket in total hip arthroplasty, which is a treatment/therapy, not a diagnostic procedure.
No
The device description clearly describes a physical implant (acetabular cup system with flanges and screws) intended for surgical implantation, not a software-only product.
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.
- Device Description: The TriFlange™ Acetabular Cup System is a physical implant designed to replace or resurface the acetabular socket in the hip. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to resurface the acetabular socket during total hip arthroplasty. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgically implanted medical device, not a diagnostic test.
N/A
Intended Use / Indications for Use
The TriFlange™ Acetabular Cup System is intended to be used with the Duraloc® UHMWPE liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
The TriFlange™ Acetabular Cup System is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
Product codes (comma separated list FDA assigned to the subject device)
87LPH, 87 MEH
Device Description
The patient specific TriFlange™ Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated Duraloc acetabular cup with three patient specific illial, ischial and pubic flanges added to reinforce weak acetabula similar to the Protrusio Cage. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabular socket and hips
Indicated Patient Age Range
skeletally mature individuals
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.
K952740, K962007, K983035, K972393, K980711
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
.
510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Marcia J. Arentz
Senior Regulatory Associate
Phone: (219) 371-4944
FAX: (219) 371-4940 |
| Trade Name: | TriFlange™ Acetabular Cup System |
| Common Name: | Patient specific flanged acetabular cup system |
| Classification: | Class II |
| Device Product Code: | Code: 87LPH Prosthesis, Hip, Semi-Constrained,
Metal/Polymer, Porous uncemented
Code: 87 MEH Prosthesis, Hip Semi-Constrained,
Uncemented, Metal/Polymer, Non-porous, Calcium-
phosphate |
| Substantially Equivalent Device: | DePuy Duraloc® 400 Acetabular Cup................................ K952740
DePuy Protrusio Cage........................................................ K962007
Biomet Patient Matched Flanged
Acetabular Component ................................................. K983035
Sulzer Inter-Op™ HA Porous
Acetabular System ......................................................... K972393
Zimmer Harris/Galante Porous........................................ K980711
Hip Prosthesis With HA/TCP Coating |
| Device Description: | The patient specific TriFlange™ Acetabular Cup System
is an acetabular cup system designed and manufactured to
match the individual patient's anatomy. The system
consists of a porous coated Duraloc acetabular cup with
three patient specific illial, ischial and pubic flanges
added to reinforce weak acetabula similar to the Protrusio
Cage. The device may be fixed in place with titanium
bone screws of various lengths through a variety of screw
holes in the flanges. |
| Intended use: | The TriFlange™ Acetabular Cup System is intended to be
used with the Duraloc® UHMWPE liners to resurface the
acetabular socket in cementless application during total
hip arthroplasty. |
1
Indications for use:
Substantial equivalence:
The TriFlange™ Acetabular Cup System is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
The TriFlange™ Acetabular Cup System with patient specific flanges is substantially equivalent to the currently marketed DePuy Duraloc® Acetabular Cup (K952740), the DePuy Protrusio Cage (K962007) the Biomet Patient Matched Flanged Acetabular Component (K983035), the Sulzer Inter-OpTM HA Porous Acetabular System (K972393) and the Zimmer Harris/Galante Porous Hip Prosthesis With HA/TCP coating (K980711).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2000
Ms. Marcia J. Arentz Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K001277
Trade Name: TriFlange™ Acetabular Cup System Regulatory Class: II Product Code: LPH, MEH Dated: April 20, 2000 Received: April 21, 2000
Dear Ms. Arentz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 - Ms. Marcia J. Arentz
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Duna R. lochner -
Celia M. 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
510(k) Number (if known): kooj 377 ---
Device Name: TriFlange™ Acetabular Cup System
Indications for Use:
The TriFlange™ Acetabular Cup System is intended to be used with the Duraloc polyethylene liners to resurface the acetabular socket in cementless application during total hip arthroplasty. The device is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by disease, deformity, or trauma including non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant.
Concurrence of CDRH, Office of Device Evaluation
D:une R. Lochner
Division Sign-O (Division Sign-On)
Division of General Restorative Devices
.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use10(k) Number_KQQ12
000003