(89 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical hip stem and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the treatment of various medical conditions affecting the hip joint, such as arthritis, avascular necrosis, and fractures, which aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
The DePuy Tri-Lock Hip Stem is described as a femoral hip stem used in joint replacement surgery, which is a therapeutic device, not a diagnostic one. Its intended use focuses on treating joint conditions rather than diagnosing them.
No
The device description clearly states it is a femoral hip stem, which is a physical implant, 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, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- DePuy Tri-Lock Hip Stem: This device is a surgical implant designed to replace a damaged hip joint. It is implanted inside the body during surgery.
The description clearly indicates it's a physical implant for surgical use, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
The DePuy Tri-Lock Hip Stem is indicated for cementless use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement;
-
- Certain cases of ankylosis.
Product codes
87 LPH
Device Description
The DePuy Tri-Lock Hip Stem consists of variously sized femoral hip stems which will be available in two versions (standard and lateralized) with a modular head design. The DePuy Tri-Lock Hip Stem employs Porocoat porous coating for use with or without cement. When it is used cementless, it is intended for tissue ingrowth to obtain biological fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
DePuy Prodigy Hip, DePuy AML Proximally-Coated Stem, DePuy Porocoat Dual Lock Total Hip System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 18 1998
K974740
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Arlene C. Saull, RAC
Sr. Submissions Associate
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
| TRADE NAME: | DePuy Tri-Lock Hip Stem |
| COMMON NAME: | Porous-coated hip prosthesis |
| CLASSIFICATION: | Class II per 888.3358: Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH: Prosthesis, Hip, Semi-Constrained Metal/Polymer,
Porous Uncemented |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | DePuy Prodigy Hip
DePuy AML Proximally-Coated Stem,
DePuy Porocoat Dual Lock Total Hip System |
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Tri-Lock Hip Stem consists of variously sized femoral hip stems which will be available in two versions (standard and lateralized) with a modular head design. The DePuy Tri-Lock Hip Stem employs Porocoat porous coating for use with or without cement. When it is used cementless, it is intended for tissue ingrowth to obtain biological fixation.
The DePuy Tri-Lock Hip Stem is indicated for cementless use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement;
- న. Certain cases of ankylosis.
Page 1 of 2
000004
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Tri-Lock Hip Stem is similar in material and intended use (cementless) to the Prodigy Hip and the AML Proximally-Coated Hip Stem, both cleared for cementless use.
The subject DePuy Tri-Lock Hip Stem is similar in material, design and size to the predicate Tri-Lock Hip Stem. (submitted as the DePuy Porocoat Dual Lock Total Hip System) which was cleared for cemented use.
All of these systems consist of ASTM F-75 Cast Cobalt Chromium Molybdenum Alloy femoral stems with porous coating made from ASTM F-75 Cobalt Chromium Molybdenum Alloy. All of the predicate modular femoral stems have identical neck tapers that use the DePuy Articul/eze Total Hip Balls, available in Cobalt Chrome and Zirconia Ceramic.
Based on the information supplied in this premarket notification submission, DePuy, Inc. believes that the subject Tri-Lock Hip Stem is substantially equivalent in terms of materials, design, sizing and intended use to the Prodigy Hip, AML Proximally-Coated Stem, and the Porocoat Dual Lock Total Hip System (predicate Tri-Lock) that have been previously cleared by the FDA. It is expected that the performance of the subject DePuy Tri-Lock Hip Stem will be similar to these predicate devices.
Arlene C. Saull
Arlene C. Saull, RAC Sr. Submissions Associate
12-18-97
Date
END OF 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FORM
Page 2 of 2
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of human profiles facing right, arranged in a way that suggests movement or flow. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 1998
Ms. Arlene C. Saull Senior Submissions Associates DePuy Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re : K974740 DePuy Tri-Lock® Hip Stem Trade Name: Requlatory Class: II Product Code: LPH Dated: December 18, 1997 December 19, 1997 Received:
Dear Ms. Saull:
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 controls provisions The general controls provisions of the Act 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.
3
Page 2 - Ms. Arlene C. Saull
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.
If you desire specific advice for your device on our labeling requlation (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,
Russell S. Hayne
An Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
DePuy Tri-Lock® Hip Stem _____________________________________________________________________________________________________________________________________________________ Device Name
Indications for Use:
The DePuy Tri-Lock Hip Stem is indicated for cementless use in the treatment of
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement;
=============================================================================================================================================================================
-
- Certain cases of ankylosis.
Concurrence of CDRH, Office of Device Evaluation:
- Certain cases of ankylosis.
OR
Plumell Payne forima
(Division Sign-Off Division of General Restorative Devices 510(k) Number _
Prescription Use
✗
Over-The Counter Use ___(Per 21 CFR 801.109)
000003