(66 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is a hip prosthesis designed to replace the proximal human femur, which directly treats conditions like severe hip pain, disability due to various forms of arthritis, and fractures.
No
This device is a prosthetic implant (M/L Taper Hip Prosthesis) used for hip replacement surgery, not for diagnosing medical conditions. The "Intended Use / Indications for Use" section clearly describes conditions for which hip replacement is performed, and the "Device Description" details the physical characteristics of the prosthesis.
No
The device description clearly describes a physical implant (femoral stem) made of titanium alloy with coatings, intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total and hemi-hip replacement, which are surgical procedures to replace a damaged hip joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a femoral stem, a physical implant designed to be surgically placed in the femur. This is a medical device used in surgery, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro tests, or providing information for diagnosis, monitoring, or screening.
In summary, the device is a surgical implant used for hip replacement, which falls under the category of a medical device for therapeutic purposes, not an In Vitro Diagnostic device.
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
Device Description
The Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating is a modular, titanium alloy femoral stem designed to replace the proximal human femur in total hip arthroplasty. It is flat, collarless, and features a proximal-to-distal taper in the mediolateral (M/L) plane. The wedge-shaped prosthesis is designed for cementless use and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. Calcicoat® Ceramic Coating (hydroxyapatite tricalcium phosphate [HA/TCP]) has been added to the porous coating to aid bony ingrowth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, 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 testing demonstrated that the M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating met performance requirements and is as safe and effective as the predicate device.
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
§ 888.3358 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/0 description: The image contains the word "zimmer" with a stylized "Z" in a circle to the left of the word. The word "zimmer" is in a bold, sans-serif font. The "Z" in the circle is also in a bold font and is black. The background of the image is white.
K042337
| K0425537 | |
|---|---|
| NOV - 4 2004 | |
| Summary of Safety and Effectiveness | |
| Submitter: | Zimmer, Inc. |
| P.O. Box 708 | |
| Warsaw, IN 46581-0708 | |
| Contact Person: | Dalene Binkley, RAC |
| Associate, Regulatory Affairs | |
| Telephone: (574) 372-4907 | |
| Fax: (574) 372-4605 | |
| Date: | August 27, 2004 |
| Trade Name: | Zimmer® M/L Taper Hip Prosthesis with Calcicoat® |
| Ceramic Coating | |
| Common Name: | Total Hip Prosthesis |
| Classification Name: | Hip joint metal/polymer/metal semiconstrained |
| porous coated uncemented prosthesis | |
| Reference and Product Code: | 21 CFR § 888.3358, LPH |
| Predicate Device: | Zimmer® M/L Taper Hip Prosthesis, manufactured |
| by Zimmer, Inc., K032726, cleared October 22, |
-
|
| Device Description: | The Zimmer® M/L Taper Hip Prosthesis with
Calcicoat® Ceramic Coating is a modular, titanium
alloy femoral stem designed to replace the proximal
human femur in total hip arthroplasty. It is flat,
collarless, and features a proximal-to-distal taper in
the mediolateral (M/L) plane. The wedge-shaped
prosthesis is designed for cementless use and is
circumferentially porous-coated with titanium alloy
plasma spray over the proximal body region.
Calcicoat® Ceramic Coating (hydroxyapatite
tricalcium phosphate [HA/TCP]) has been added to
the porous coating to aid bony ingrowth. |
| Intended Use: | Total hip replacement for the following: severe hip
pain and disability due to rheumatoid arthritis,
osteoarthritis, traumatic arthritis, polyarthritis, |
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The letter "Z" is black, and the circle is white with a black outline. The word "zimmer" is also black.
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.
The M/L Taper Hip Prosthesis with Calcicoat * Ceramic Coating is manufactured, packaged, 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
Performance Data (Nonclinical and/or Clinical):
Comparison to Predicate Device:
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that the M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating met performance requirements and is as safe and effective as the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 2004
Ms. Darlene Binkley, RAC Associate, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K042337
Trade/Device Name: Zimmer® M/L Taper Hip Prosthesis with Calicoat® Ceramic Coating 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: October 13, 2004 Received: October 15, 2004
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 practicc requirements as set 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.
3
Page 2 - Ms. Darlene Binkley, RAC
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/dsma/dsmamain.html
Sincerely yours,
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
4
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating
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 (ONE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K042337 Page 1 of 1