(30 days)
No
The device description and intended use are purely mechanical, and there is no mention of AI/ML terms or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is a hip stem used in total hip arthroplasty to replace a damaged hip joint, which is a therapeutic intervention aimed at increasing patient mobility and reducing pain.
No
The device, a total hip arthroplasty system, is intended to replace a damaged hip joint and restore mobility, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical hip stem made of titanium alloy with a porous coating, intended for surgical implantation. This is a hardware device, 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 damaged hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and construction of a femoral hip stem, a physical implant.
- 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.
- Anatomical Site: The device is used directly within the hip joint, not for testing samples taken from the body.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is a surgical implant used to treat a condition.
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 with a prosthetic hip joint articulation in patients where there 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
Product codes
LPH
Device Description
The Titanium Tri-Lock Hip Stem is porous coated and intended for cementless use in total hip arthroplasty. The femoral hip stem is manufactured from ASTM F-620, forged titanium alloy. Its porous coating is manufactured from commercially pure titanium beads conforming to ASTM F-67. The subject modified hip stem is intended to be used with a modular head (manufactured from Cobalt Chrome or Zirconia ceramic) 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
Hip
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 Titanium Tri-Lock Hip Stem demonstrated adequate performance in design control activities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
SUMMARY OF SAFETY AND EFFECTIVE
| 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 |
| TRADE NAME: | Titanium Tri-Lock® Hip Stem |
| COMMON NAME: | Hip prosthesis |
| CLASSIFICATION: | Class II per 888.3358 Hip joint metal/polymer semi-
constrained porous-coated uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH Prosthesis, hip, semi-constrained,
metal/polymer, porous uncemented |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | Tri-Lock® Hip Stem (CoCr), cleared on July 26, 2000
in K001982 |
DEVICE DESCRIPTION AND INTENDED USE:
The Titanium Tri-Lock Hip Stem is porous coated and intended for cementless use in total hip The The The femoral hip stem is manufactured from ASTM F-620, forged titanium alloy. Its armoplasty. The remeratured from commercially pure titanium beads conforming to ASTM F-67. The subject modified hip stem is intended to be used with a modular head (manufactured 07. The sayler modifice or Zirconia ceramic) which locks onto the femoral hip stem. The modular head articulates with an acetabular cup of an appropriate diameter.
INDICATIONS:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by rolar mp artill opines - 12 moint articulation in patients where there 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
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject Titanium Tri-Lock Hip Stem is identical (except for the material) to the previously cleared Tri-Lock Hip Stem (CoCr) that was cleared in 2000. It has the same intended use, same dimensions, same method of manufacture, same design, same sterilization and packaging methods. The Titanium Tri-Lock Hip Stem demonstrated adequate performance in design control activities.
000004
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure in motion or a stylized representation of a bird in flight.
MAR - 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Arlene C. Saull Senior Regularoty Associate DePuy Orthopaedics, Inc. 700 Orthopaedics Drive P.O. Box 988 Warsaw, Indiana 46581
Re: K010367
Trade Name: Titanium Tri-Lock® Hip Stem Regulatory Class: II Product Code: LPH Dated: February 6, 2001 Received: February 7, 2001
Dear Ms. Saull:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your became of (sice is substantially equivalent (for the indications for use above and we nave determined an marketed in interstate commerce prior to May 28, 1976, the stated in the oneround) to active Amendments, or to devices that have been reclassified in chacinein call of 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 therefore, market the Act include requirements for annual registration, listing of devices, eondor provisions of the exactive, 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 ( remarket inpreviously in the Code of Federal Regulations, Title 21, Parts 800 to 895. areetming your 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 moponently are a cara and 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire spoonly arrivers. Jagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (301) 594-4037. Trudinonally, 10. ques at (301) 594-4639. Also, please note the regulation
10. and contact the Office of Compliance at (301) 594-4639. Also, please of any prease contact the Office or Compilance ex (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionnees and exceller and exceller of at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
La Mark McMullinson
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)_Kol 6367
Device Name: Tri-Lock® Hip Stem
Indications for Use:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by I otal inp attitle plasty is meendou to patients where there is evidence of sufficient replacing the damaged mp your attronaments. 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.
- Certain cases of ankylosis. న.
Concurrence of CDRH, Office of Device Evaluation:
Mark N Mulkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K010367 510(k) Number --
Prescription Use
OR
Over-The Counter Use (Per 21 CFR 801.109)