(126 days)
Not Found
No
The summary describes a hip prosthesis, a mechanical implant, and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip prosthesis, which is a medical implant designed to replace damaged hip joints, thereby alleviating pain and improving function for patients with various debilitating conditions. This aligns with the definition of a therapeutic device, as it actively treats or palliates a disease or injury.
No
Explanation: This document describes hip prostheses for replacement surgeries, which are therapeutic devices, not diagnostic tools. Their purpose is to treat conditions, not to identify or diagnose them.
No
The device description clearly describes a physical hip prosthesis (femoral stem) made of titanium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes a surgical implant for replacing a hip joint due to various conditions affecting the bone and joint structure. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details a femoral stem prosthesis, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is a surgical implant used for treatment and restoration of function, not for diagnosis.
N/A
Intended Use / Indications for Use
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Product codes
LPH, MEH, LZO
Device Description
The Zimmer M/L Taper Hip Prostheses are flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating.
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)
Non-Clinical Performance and Conclusions:
Analysis of the modified devices indicates that they are substantially equivalent to the predicates.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032726, K042337, K030265, K973714
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
K060040 (pg 1 of 2)
Summary of Safety and Effectiveness
MAY 12 2006
Contact Person:
Date:
Trade Name:
Common Name:
Classification Names and References:
Predicate Devices:
Device Description:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Karen Cain, RAC Manager, Corporate Regulatory Affairs Telephone: (574) 372-4219 Fax: (574) 372-4605
January 5, 2006
Zimmer® M/L Taper Hip Prosthesis
Total Hip Prosthesis
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR § 888.3358, product code LPH
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 21 CFR § 888.3353, product codes MEH, LZO
Zimmer® M/L Taper Hip Prosthesis, K032726, cleared October 22, 2003
Zimmer M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating, K042337, cleared November 4, 2004
Zimmer CPT® 12/14, K030265, cleared March 4, 2003
Zimmer VerSys® Beaded Mid-Coat Stem, K973714, cleared December 24, 1997
The Zimmer M/L Taper Hip Prostheses are flat, collarless, modular femoral stems with a proximal to distal taper in the mediolateral plane. The
1
KO60040 (p) 2 of 2
prostheses are circumferentially coated with titanium alloy plasma spray over the proximal body region and are available in standard and extended offset options, with or without Calcicoat Ceramic Coating.
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head: pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
An additional size option and an additional neck length option are being added to the previously cleared Zimmer M/L Taper Hip Prosthesis system.
Non-Clinical Performance and Conclusions:
Analysis of the modified devices indicates that they are substantially equivalent to the predicates.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings and a base that resembles flowing water. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, with the words evenly spaced to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2006
Zimmer, Inc. c/o Ms. Karen Cain Manager, Corporate Regulatory Affairs P.O. Box 708 -Warsaw, Indiana 46581-0708
Re: K060040
Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, MEH, LZO Dated: April 13, 2006
Received: April 14, 2006
Dear Ms. Cain:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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
3
Page 2 - Ms. Karen Cain
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® M/L Taper Hip Prosthesis
Indications for Use:
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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KOSOD40 ***(k) Number
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