(25 days)
Not Found
No
The summary describes a mechanical hip prosthesis and does not mention any AI/ML components or functionalities.
Yes
The device is a hip prosthesis, intended to replace diseased or damaged hip joints, thereby treating severe hip pain, disability, and various hip conditions.
No
The device is a hip implant, specifically a femoral stem, used for hip replacement surgeries. Its purpose is to treat severe hip pain and disability due to various conditions, not to diagnose them.
No
The device description clearly describes a physical implant (femoral stem) and its components, not a software application.
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 total and hemi-hip replacement. This is a therapeutic device used in vivo (within the body) to treat musculoskeletal conditions.
- Device Description: The description details a modular femoral stem, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
Therefore, this device falls under the category of a surgical implant or prosthetic 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 (comma separated list FDA assigned to the subject device)
KWA, JDL, LPH, LWJ, MEH
Device Description
The Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System is a modular, wedge-shaped stem that is coated with commercially pure titanium alloy plasma spray.
The modular neck options allow 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 patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, femoral neck, femur
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:
Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Summary of Safety and Effectiveness
30 Jul 07
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley, RAC
Senior Associate, Regulatory Affairs
Telephone: (574) 372-4907
Fax: (574) 372-4605 |
| Date: | July 3, 2007 |
| Trade Name: | Zimmer® M/L Taper Hip Prosthesis with Kinectiv™
Technology System |
| Common Name: | Total Hip Prosthesis |
| Classification Name
and Reference: | 1. KWA - Hip joint metal/metal semi-constrained
with uncemented acetabular shell, 21 CFR § 888.
3330
2. JDL - Hip joint metal/metal semi-constrained
with cemented acetabular shell, 21 CFR § 888. 3320
3. LPH - Prosthesis, hip, semi-constrained
metal/polymer porous uncemented, 21 CFR § 888.
3358
4. LWJ - Prosthesis, hip, semi-constrained
metal/polymer uncemented, 21 CFR § 888. 3360
5. MEH - Prosthesis, hip, semi-constrained
uncemented metal polymer, non-porous, calcium
phosphate, 21 CFR § 888. 3353 |
| Predicate Device: | Zimmer® M/L Taper Hip Prosthesis with Modular
Neck Technology, manufactured by Zimmer, Inc.,
K063251, cleared January 24, 2007. |
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| Device Description: | The Zimmer M/L Taper Hip Prosthesis with
Kinectiv Technology System is a modular, wedge-
shaped stem that is coated with commercially pure
titanium alloy plasma spray. |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The modular neck options allow 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 patient
anatomies. |
| Intended 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. |
| Comparison to Predicate Device: | The Zimmer M/L Taper Hip Prosthesis with Kinetiv
Technology System is packaged, manufactured, and
sterilized using the same materials and processes as
its predicate. The subject device also has the same
intended use and fixation methods as the predicate. |
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Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that the Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System met performance requirements and is as safe and effective as its predicate.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Ms. Dalene T. Binkley Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
K071856 Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Kinectiv® Technology System 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 Dated: July 3. 2007 Received: July 5, 2007
JUL 3 0 2007
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, 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
Image /page/3/Picture/9 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus-like symbol with three intertwined strands, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Re:
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Page 2 - Ms. Dalene T. Binkley
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara BruchuP
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 - Ms. Dalene T. Binkley
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. f/t:JSG:afb:7/30/07 OC Numbers: Division of Enforcement A 240-276-0115 Dental, ENT and Ophthalmic Devices Branch 240-276-0115 OB/GYN, Gastro. & Urology Devices Branch 240-276-0115 General Hospital Devices Branch 240-276-0115 General Surgery Devices Branch 240-276-0115 Division of Enforcement B 240-276-0120 Cardiovascular & Neurological Devices Branch 240-276-0120 Orthopedic, Physical Medicine & Anesthesiology Devices and Radiological 240-276-0120 Devices
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071856
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System
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, Office of Device Evaluation (ODE)
Barbara Medium for MAM
Division of Ge Restorati and Neurological Devices
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510(k) Number K071856
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