(70 days)
Not Found
Not Found
No
The document describes a mechanical knee implant and its testing, with no mention of AI or ML.
Yes
The device is described as a component of a total knee system intended for use in total knee arthroplasty to relieve pain and restore knee functions, addressing various degenerative joint diseases and injuries. This aligns with the definition of a therapeutic device.
No
The device described is a knee system patella component, which is an implant used for total knee arthroplasty to relieve pain and restore knee function. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "patellar components of a total knee system," which are physical implants, not software. The performance studies also describe testing of physical properties like porous coating, contact area, and material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Duracon® Knee System Patella components are implants used in total knee arthroplasty to replace articulating surfaces of the patella. This is a surgical procedure involving a physical device implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
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
The Duracon® Knee System Patella components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- Noninflammatory degenerative joint disease including osteoarthritis; traumatic arthritis or avascular necrosis;
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; .
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee. ●
These products are intended to achicve fixation without the use of bone cement.
Product codes
MBH
Device Description
The device patellar components of a total knee system. These components are used for the replacement of the articulating surfaces of the patella to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPE material properties in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003. The testing also includes safety testing for the Peri-Apatite coating. The results demonstrate that the Duracon Conversion Patella with Porous and Peri-Apatite coatings is safe and effective for use in total knee replacement without bone cement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Duracon® Conversion and X-Small Symmetric Patella with Porous Coating for uncemented use.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 corporate Boulevard Rockville MD 20850
MAR 3 0 2005
Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howrnedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K043374
Trade/Device Name: Duracon® Conversion and X-Small Patella with Peri-Apatite® Coating Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint, patellofemorotibial, metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Codes: MBH Dated: December 2,2004 Received: December 8,2004
Ms. Duchene:
This letter corrects our substantially equivalent letter of February 16, 2005 regarding the incorrect received date of January 8,2004. The correct received date is shown above.
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 (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 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
1
Page 2- Ms. Denise Duchene
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 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 continue 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 Complianceat (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.
Styp A. Charles
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page I of 1
510(k) Number (if known): K043374
Duracon® Conversion and X-Small Patella with Peri-Apatite® Coating Device Name:
Indications for Use:
The Duracon® Knee System Patella components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- Noninflammatory degenerative joint disease including osteoarthritis; traumatic arthritis or ● avascular necrosis;
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; .
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee. ●
These products are intended to achicve fixation without the use of bone cement.
Prescription Usc
OR
Over-the-counter Usc_
(c43374
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Mark A. Milken
and Neimingica
ਾਂ ਅਤੇ ਅੰਗ੍ਰੇ ਦੇ ਬਲਵ
3
FEB | 6 2005
Summary of Safety and Effectiveness
K 043374
| Contact Person: | Denise Duchene
Sr. Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah, NJ 07430
(201) 831-5612 (Phone)
(201) 831-6038 (FAX) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 12,2004 |
| Device: | Duracon® Conversion and X-Small Symmetric Patella with Peri-
Apatite® Coating |
| Classification: | Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;
Uncemented prosthesis - Class II - 21 CFR 888.3565 --Product
Code: MBH |
| Predicate Devices: | Duracon® Conversion and X-Small Symmetric Patella with Porous
Coating for uncemented use. |
| Indications for Use: | The Duracon® Patella components are for use in total knee
arthroplasty to relieve pain and restore knee function for
indications such as: noninflammatory degenerative joint disease
including osteoarthritis, traumatic arthritis or avascular necrosis;
rheumatoid arthritis; correction of functional deformity; revision
procedures where other treatments or devices have failed; post
traumatic loss of joint anatomy, particularly when there is patello-
femoral erosion, dysfunction or prior patellectomy; and,
irreparable fracture of the knee. |
| | These products are intended to achieve fixation without the use of
bone cement |
| Proposed Modification: | To add a Peri-Apatite® coating to the Conversion and X-Small
Symmetrical Patella components. |
| Device Description: | The device patellar components of a total knee system. These
components are used for the replacement of the articulating
surfaces of the patella to relieve pain, instability and the restriction
of motion due to degenerative bone disease, including
osteoarthritis, rheumatoid arthritis, failure of other devices or
trauma. |
4
Summary of Data:
A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPE material properties in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003. The testing also includes safety testing for the Peri-Apatite coating. The results demonstrate that the Duracon Conversion Patella with Porous and Peri-Apatite coatings is safe and effective for use in total knee replacement without bone cement.