(59 days)
The Duracon® Total Knee System 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 with and without the use of bone cement.
The device includes femoral, tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
The provided text describes the Duracon® Total Knee System and its regulatory submission (K032163) for an additional indication for use without bone cement. The study described focuses on demonstrating equivalence to predicate devices rather than a typical clinical study with acceptance criteria for device performance in patients.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in terms of clinical performance (e.g., pain reduction, range of motion improvement) that a new device would need to meet through a clinical study. Instead, the "acceptance criteria" are related to established engineering and material standards for knee prostheses. The "reported device performance" refers to the results of testing demonstrating compliance with these standards.
| Acceptance Criteria (Related to "Study") | Reported Device Performance |
|---|---|
| Requirements outlined in 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, for: - Porous coating characterization - Baseplate fatigue testing - Contact area / stress analyses - Range of motion / range of constraint testing - Locking mechanism testing - UHMWPe material properties | The results demonstrate that the Duracon Total Knee System meets the requirements of this document. |
| Equivalence of the proposed products to the predicate devices. | Demonstrated through risk analysis and research and development testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document discusses "research and development testing" on the components of the Duracon Total Knee System. This implies in-vitro or bench testing on a sample of the manufactured devices or their materials.
- Sample Size: Not explicitly stated. The testing would have been conducted on a representative sample of device components (e.g., a certain number of porous coatings, baseplates, UHMWPe samples).
- Data Provenance: The testing was likely conducted in a laboratory setting by Howmedica Osteonics Corp. (the manufacturer) or a contracted lab. It is not clinical data from patients, therefore concepts like "country of origin" or "retrospective/prospective" don't apply in the human data sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the "study" described is not a clinical study involving human patients, and therefore, there is no "ground truth" to be established by experts in a clinical context (e.g., radiologists, pathologists). The "ground truth" in this context is the physical and mechanical properties of the device components as measured by scientific instruments and methods, compared against engineering specifications.
4. Adjudication Method for the Test Set:
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study described is a benchtop engineering and materials testing study, not a clinical study involving human readers or patients.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable. The device is a physical knee implant, not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used:
The "ground truth" used for this type of submission is:
- Engineering Specifications and Standardized Test Methods: Compliance with established industry standards and guidance documents (e.g., from the FDA) for mechanical strength, material properties, porous coating characteristics, etc.
- Predicate Device Performance: Documentation that the proposed device performs equivalently to the legally marketed predicate devices, particularly regarding its mechanical and material aspects.
8. The Sample Size for the Training Set:
This concept is not applicable. There is no "training set" in the context of an engineering and materials testing study for a physical medical device. Training sets are relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established:
This concept is not applicable for the same reasons as point 8.
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Duracon® Total Knee System
SEP 1 2 2003
Summary of Safety and Effectiveness
| Contact Person: | Denise DucheneSr. Regulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17 SouthAllendale, NJ 07401(201) 831-5612 (Phone)(201) 831-6038 (FAX) |
|---|---|
| Date: | June 24, 2003 |
| Device: | Duracon® Total Knee System |
| Classification: | Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;Uncemented prosthesis - Class II - 21 CFR 888.3565 |
| Predicate Devices: | Duracon® Total Knee System |
| Indications for Use: | The Duracon® Total Knee System components are for use in totalknee arthroplasty to relieve pain and restore knee function forindications such as: noninflammatory degenerative joint diseaseincluding osteoarthritis, traumatic arthritis or avascular necrosis;rheumatoid arthritis; correction of functional deformity; revisionprocedures where other treatments or devices have failed; posttraumatic 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 with and withoutthe use of bone cement |
| Proposed Modification: | Additional indication for use of product without bone cement. |
| Device Description: | The device includes femoral, tibial and patellar components of atotal knee system. These components are used for the replacementof the bearing and/or articulating surfaces of the distal femur,proximal tibia to relieve pain, instability and the restriction ofmotion due to degenerative bone disease, including osteoarthritis,rheumatoid arthritis, failure of other devices or trauma. |
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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, baseplate fatigue testing, 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 results demonstrate that the Duracon Total Knee System meets the requirements of this document.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing another, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2003
Ms. Denise Duchene Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401
Re: K032163 Trade/Device Name: Duraco® Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Product Code: MBH Dated: July 11, 2003 Received: July 21, 2003
Dear Ms. Duchene:
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 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.
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Page 2 - Ms. Denise Duchene
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 (301) 594-4659. 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,
Miriam C. Provost
Col 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
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K032163 510(k) Number (if known):
Device Name: Duracon® Total_Knee System
Indications for Use:
The Duracon® Total Knee System 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 achieve fixation with and without the use of bone cement.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use
OR Over-the-Counter Use (Per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K032163
§ 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.