(91 days)
Not Found
Not Found
No
The provided text describes a mechanical hip implant system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for hip replacement procedures to alleviate pain and disability due to structural damage in the hip joint, which aligns with the definition of a therapeutic device.
No
The description indicates the device is a "Modular Total Hip System" used for replacement procedures in patients with hip joint issues, not for diagnosing conditions.
No
The device description and other sections are not found, but the intended use clearly describes a "Modular Total Hip System," which is a physical implant, not software.
Based on the provided information, the Z™ - Series Modular Total Hip System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement procedures. This is a medical device used in vivo (within the body) to treat a physical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Use in a laboratory setting
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Z™ - Series Modular Total Hip System is a prosthetic implant, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
The Z™ - Series Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Product codes
LPH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three curved lines forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
DEC - 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sam Son Vice President, Technical Affairs ()steoimplant Technology, Inc. 11201 Pepper Road Hunt Valley, Maryland 21031
Re: K032729 Trade/Device Name: Z™-Series Modular Total Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: August 27, 2003 Received: September 25, 2003
Dear Mr. Son:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally to regally the Medical Device Americal Food Drug commerce provided to May 20, 1776, the encordance with the provisions of the Federal Food. Drug. devices that have occh receasinou in access approval of a premarket approval application (PMA). and Cosmette Act (710) that do novice. subject to the general controls provisions of the Act. The I ou may, mercrore, market the Act include requirements for annual registration. Insting of general controls provisions of the research and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 above) and Existing major regulations affecting your device can thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may ou louice in the over ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Ficase be advised had 1171 3 issuance or our device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of any it call the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607), anomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Sam Son
This letter will allow you to begin marketing your device as described in your section 510(k) I mis letter will anow you to begin manceing your antial equivalence of your device to a legally premarket nother in the PDF mailing of easification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your dones at (301) 594-4659. Also, please note the regulation entitled. Colliaci the Office of Comphalled as (be in the motification" (21CFR Part 807.97). You may obtain "Misorallaning by reference to premaiter the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millerson
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
2
510(k) Number (if known)_ Ko32729
Device Name: Z™ - Series Modular Total Hip System
Indications For Use:
The Z™ - Series Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Mark N. Millen
Division of General Restorative
Over-The-Counter Use _
(Optional Format 1-2-96)
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