(30 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged 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
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 Chromium alloy or Zirconia ceramic) which locks onto the femoral hip stem. The modular head articulates with an acetabular cup of an appropriate diameter.
Here's an analysis of the provided documents regarding the Titanium Tri-Lock® Hip Stem, focusing on the absence of information related to acceptance criteria and device performance as if it were an AI/software device.
Key Observation: The provided documents (510(k) summary and FDA clearance letter) pertain to a medical device (hip stem), not a software or AI-driven device. As such, the standard information requested for AI/software device evaluations (like acceptance criteria, sample sizes for test/training sets, expert consensus, MRMC studies, etc.) is not applicable and therefore not present in these documents.
Instead, the documents focus on demonstrating substantial equivalence to a predicate device based on manufacturing, materials, design, and intended use for a physical implant.
Based on the provided documents, it is not possible to answer the specific questions related to AI/software device acceptance criteria and study details.
The Titanium Tri-Lock® Hip Stem is a physical medical implant, and its clearance relies on demonstrating substantial equivalence to an already marketed device (Tri-Lock® Hip Stem) based on:
- Identical intended use
- Identical dimensions
- Identical method of manufacture
- Identical design
- Identical sterilization and packaging methods
- Adequate performance in design control activities (which typically involve mechanical testing, wear testing, material characterization, biocompatibility, etc., for implants, not AI performance metrics).
- The only difference is the material (Titanium vs. CoCr).
Therefore, the requested information categories are not present in these documents.
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SUMMARY OF SAFETY AND EFFECTIVE
| NAME OF FIRM: | DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988 |
|---|---|
| 510(k) CONTACT: | Arlene C. Saull, RACSenior 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 EQUIVALENTDEVICE: | Tri-Lock® Hip Stem (CoCr), cleared on July 26, 2000in 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.
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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.
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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
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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)
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§ 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.