(89 days)
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.
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.
This submission is a 510(k) summary for a hip stem device (DePuy Tri-Lock Hip Stem). It relies on substantial equivalence to predicate devices rather than clinical studies to demonstrate safety and effectiveness. Therefore, the questions related to studies, ground truth, and expert evaluation are not directly applicable.
Here's an analysis of the provided information, addressing what is present and noting what is not:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the typical sense for a performance study (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, the basis for approval is substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The DePuy Tri-Lock Hip Stem is found to be substantially equivalent in terms of materials, design, sizing, and intended use to the predicate devices: DePuy Prodigy Hip, AML Proximally-Coated Stem, and Porocoat Dual Lock Total Hip System. The performance is expected to be similar to these predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is a 510(k) for a medical device (hip stem) seeking clearance based on substantial equivalence. It does not involve a "test set" of data from clinical studies in the way a diagnostic or AI device would. The approval is based on comparison to existing, legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "test set" requiring ground truth establishment by experts for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As there is no test set or clinical study data requiring adjudication, this question is not relevant to this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a hip stem, not an AI-powered diagnostic device or a device involving human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant (hip stem), not an algorithm or software. Standalone performance is not relevant in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As stated, there is no "ground truth" derived from clinical data in this submission. The "truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which the new device is compared.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device and does not involve a learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. Since there is no training set, there is no ground truth establishment for it.
{0}------------------------------------------------
MAR 18 1998
K974740
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988 |
|---|---|
| 510(K) CONTACT: | Arlene C. Saull, RACSr. Submissions AssociateDePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, 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 |
| SUBSTANTIALLYEQUIVALENT DEVICES: | DePuy Prodigy HipDePuy 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
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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
§ 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.