(89 days)
No
The summary describes a mechanical hip prosthesis 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 surgically implanted to replace damaged hip joints, alleviating pain and restoring function for patients with various musculoskeletal conditions. This directly impacts and improves a patient's health condition.
No
Explanation: This document describes a Zimmer M/L Taper Hip Prosthesis, which is an implantable device used for hip replacement surgery. Its intended use is to treat severe hip pain and disability due to various conditions, as well as for hemi-hip replacement. It is a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical implant (femoral stem) made of titanium alloy, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for hip replacement, addressing various conditions affecting the hip joint. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The device is a hip prosthesis (femoral stem) designed to be surgically implanted. This is a medical device used in treatment, not for analyzing samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition in vitro.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
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.
This femoral stem is for cementless use only.
Product codes
KWA, JDL, LPH, LWJ, MEH, LZO
Device Description
The Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology is a modular, wedgeshaped stem that is coated with commercially pure titanium alloy plasma spray that is available with and without Calcicoat Ceramic Coating. This stem is designed for cementless use only.
The modular neck option allows for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of different patients' anatomies.
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 testing demonstrated that the M/L Taper Hip Prosthesis with Modular Neck Technology met performance requirements and is as safe and effective as the predicate devices.
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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Summary of Safety and Effectiveness
Submitter:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708 JAN 2 4 2007
Dalene T. Binkley, RAC Senior Associate, Regulatory Affairs Telephone: (574) 372-4907 Fax: (574) 372-4605
January 23, 2006
Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology
Total Hip Prosthesis
-
KWA - Hip joint metal/metal semi-constrained with uncemented acetabular shell, 21 CFR § 888. 3330
-
JDL - Hip joint metal/metal semi-constrained with cemented acetabular shell, 21 CFR & 888. 3320
-
LPH - Prosthesis, hip, semi-constrained metal/polymer porous uncemented, 21 CFR & 888. 3358
-
LWJ - Prosthesis, hip, semi-constrained metal/polymer uncemented (hemi-hip), 21 CFR § 888. 3360
-
MEH - Prosthesis, hip, semi-constrained uncemented metal polymer, non-porous, calcium phosphate, 21 CFR § 888. 3353
Zimmer® M/L Taper Hip Prosthesis, manufactured by Zimmer, Inc., K032726, cleared October 22, 2003
1
p. 2/3
Profemur TL Hip Stem manufactured by Wright Medical Technology, Inc., K060358, cleared May 10, 2006
Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating, manufactured by Zimmer, Inc., K042337, cleared November 4, 2004
The Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology is a modular, wedgeshaped stem that is coated with commercially pure titanium alloy plasma spray that is available with and without Calcicoat Ceramic Coating. This stem is designed for cementless use only.
The modular neck option allows for soft tissue balancing and easier restoration of the hip joint center of rotation. The modularity feature will allow surgeons to independently equalize leg length and optimize offset while, at the same time, maximizing joint stability for a variety of different patients' anatomies.
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.
This femoral stem is for cementless use only.
Device Description:
Intended Use:
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063251
f. 3/3
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The M/L Taper Hip Prosthesis with Modular Neck Technology is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices.
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Modular Neck Technology met performance requirements and is as safe and effective as the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. c/o Ms. Dalene T. Binkley Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
JAN 2 4 2007
Re: K063251
Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL, LPH, LWJ, MEH, LZO Dated: October 26, 2006 Received: October 27, 2006
Dear Ms. Binkley:
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. Iisting 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
4
Page 2 - Ms. Dalene T. Binklev
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 Souall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html (
Sincerely yours,
for
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K06 3251
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology
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.
This femoral stem is for cementless use only.
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. (
currence of CDRH, Office of Device Evaluation (ODE)
(Division Sigu-On)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number 1106325