Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical implant (total knee system) and its performance testing, with no mention of AI/ML capabilities or related data analysis.

Therapeutic

Yes
The device is a total knee replacement system intended to relieve pain and restore knee function due to degenerative bone disease or trauma, which makes it a therapeutic device.

Diagnostic

No

Explanation: The device description clearly states that these are components for a total knee replacement system used to "relieve pain and restore knee function" and "replace the bearing and/or articulating surfaces." This indicates a therapeutic or reconstructive purpose, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it includes "femoral, tibial and patellar components of a total knee system," which are physical hardware components.

IVD (In Vitro Diagnostic)

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 replacing knee joint components to relieve pain and restore function. This is a therapeutic intervention performed in vivo (within the body).
Device Description: The description details physical components (femoral, tibial, patellar) designed for surgical implantation.
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 outside the body.

Therefore, the Duracon® Total Knee System is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 without the use of bone cement.

Product codes

MBH

Device Description

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 and 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, 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 testing also includes safety testing for the Peri-Apatite coating. The results demonstrate that the Duracon Total Knee System with Peri-Apatite coating is safe and effective for total knee replacement without bone cement.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Duracon® Total Knee System

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K032418

Duracon® Total Knee System with Peri-Apatite Coating

510(k) Premarket Notification

SEP 1 1 2003

Summary of Safety and Effectiveness

| Contact Person: | Denise Duchene
Sr. Regulatory Affairs Specialist
Howmedica Osteonics Corp.
59 Route 17 South
Allendale, NJ 07401
(201) 831-5612 (Phone)
(201) 831-6038 (FAX) | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Date: | July 14, 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 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 | | |
| Proposed Modification: | bone cement
To add a Peri-Apatite coating and allow for use without bone
cement. | | |
| Device Description: | 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 and 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. | | |

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1

K032418

Duracon® Total Knee System with Peri-Apatite Coating

510(k) Premarket Notification

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 testing also includes safety testing for the Peri-Apatite coating. The results demonstrate that the Duracon Total Knee System with Peri-Apatite coating is safe and effective for total knee replacement without bone cement.

2

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 11 2003

Ms. Denise Duchene Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401

Re: K032418

Trade/Device Name: Duracon® Total Knee System with Peri-Apatite Coating Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Product Code: MBH Dated: August 4, 2003 Received: August 5, 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 (OS) 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. 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

for 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

Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Duracon® Total Knee System with Peri-Apatite Coating

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 without the use of bone cement.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR
(Per 21 CFR 801.109) | Over-the-Counter Use | |
|------------------|----------------------------------|----------------------|--|
| | Mirram C. | Moves | |
| | (Division Sign-Off) | | |
| | Division of General, Restorative | | |
| | and Neurological Devices | | |

510(k) Number K032418