(27 days)
Tri-Lock® Hip Stem
Not Found
No
The 510(k) summary describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a hip implant intended to replace a damaged hip joint and reduce pain, which are therapeutic functions.
No
The description indicates the device is a Tri-Lock Hip Stem used for total hip arthroplasty, which is a treatment (replacement of a damaged joint), not a diagnostic tool for identifying a condition.
No
The device description clearly states it is a "porous coated femoral hip stem" and a "modular head," both manufactured from physical materials (ASTM F-75 CoCr). This indicates a physical implant, not a software-only device.
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 procedure (total hip arthroplasty) to replace a damaged hip joint. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (hip stem and modular head) designed to be surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a replacement for a damaged anatomical structure.
N/A
Intended Use / Indications for Use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 1. rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- న్. Certain cases of ankylosis. ·
Product codes (comma separated list FDA assigned to the subject device)
87 LPH Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented, LPH
Device Description
The Tri-Lock Hip Stem is porous coated and intended for cementless use in total hip arthroplasty.
The Tri-Lock Hip Stem is part of a modular system for use in total hip replacement. The femoral component is provided as two separate units, a porous coated femoral hip stem manufactured from ASTM F-75 CoCr and a modular head also manufactured from ASTM F-75 CoCr. which locks onto the femoral hip stem. The modular head articulates with an acetabular cup of an appropriate diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, hip joint
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)
The Tri-Lock Hip Stem demonstrated adequate performance in design control activities.
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.
Tri-Lock® Hip Stem, cleared via 510(k) on 03-18-98
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
JUL 2 6 2000
SUMMARY OF SAFETY AND EFFECTIVENESS
NAME OF FIRM:
DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988
510(k) CONTACT:
Arlene C. Saull. RAC Senior Regulatory Associate
Tri-Lock® Hip Stem
Hip prosthesis
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
888.3358 Hip joint metal/polymer semi-constrained cementless prosthesis
00198
DEVICE PRODUCT CODE:
87 LPH Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
SUBSTANTIALLY EQUIVALENT DEVICES:
Tri-Lock® Hip Stem, cleared via 510(k) on 03-18-98
DEVICE DESCRIPTION AND INTENDED USE:
The Tri-Lock Hip Stem is porous coated and intended for cementless use in total hip arthroplasty.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The Tri-Lock Hip Stem is part of a modular system for use in total hip replacement. The femoral component is provided as two separate units, a porous coated femoral hip stem manufactured from ASTM F-75 CoCr and a modular head also manufactured from ASTM F-75 CoCr. which locks onto the femoral hip stem. The modular head articulates with an acetabular cup of an appropriate diameter.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Tri-Lock Hip Stem has the following similarities to the previously cleared Tri-Lock Hip Stems that were cleared in 1998; same intended use; same method of manufacture; same design; same sterilization and packaging methods. The Tri-Lock Hip Stem demonstrated adequate performance in design control activities.
000003
1
Image /page/1/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 an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2000
Ms. Arlene C. Saull. RAC Senior Regulatory Associate Depuy Orthopaedics Incorporated P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K001982
Trade Name: Tri-Lock 6.3 mm Hip Stem Regulatory Class: II Product Code: LPH Dated: February June 23, 2000 Received: June 29, 2000
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 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.
2
Page 2 - Ms. Arlene C. Saull, RAC
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Donna 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
3
510(k) Number (if known)
Device Name: Tri-Lock® Hip Stem
Indications for Use:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 1. rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- న్. Certain cases of ankylosis. ·
Concurrence of CDRH, Office of Device Evaluation:
Dama R. Lochner.
Division Sign-Off) Jivision of General Resorativ 510(k) Number_KO019
Prescription Use
OR
Over-The Counter Use (Per 21 CFR 801.109)