(165 days)
Not Found
Not Found
No
The device description focuses on the physical design and mechanical properties of a tibial insert for knee replacement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a tibial insert used in total knee arthroplasty to correct functional deformity and replace damaged joint surfaces, directly treating a medical condition.
No
This device is a tibial insert, which is a component of a total knee replacement system used for surgical implantation, not for diagnosing conditions.
No
The device description clearly describes a physical implant made of ultra-high molecular weight polyethylene, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a component of a total knee system for primary cemented total knee arthroplasty. This is a surgical procedure performed in vivo (within the body) to replace a damaged knee joint.
- Device Description: The description details a physical implant made of ultra-high molecular weight polyethylene, designed to articulate with other components of a knee replacement system. This is a medical device intended for implantation, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
The device is a surgical implant used to treat a medical condition directly within the patient's body.
N/A
Intended Use / Indications for Use
The Duracon® CS (Condylar Stabilizing) Tibial Inserts are intended to be used with Duracon® Universal and Cruciform tibial baseplates, Duracon® Cruciate Retaining femoral components and Duracon® patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized.
Indications:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic I arthritis or avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee
Product codes
JWH
Device Description
The subject Duracon® CS Tibial Insert is an ultra-high molecular weight polyethylene tibial insert designed to be used with the femoral, tibial, and patellar components of the Duracon® Total Knee System. This insert is available in small, medium, large, and extralarge sizes in the following thicknesses: 9mm, 11mm, 16m, 19mm, 22mm, and 25mm. The subject insert has a dished articulating surface geometry to provide anatomic rollback, flexion-extension and internal-external rotation. The subject tibial insert features a raised anterior eminence designed to provide greater anterior constraint in situations where the posterior cruciate ligament is not present or not functional. This anterior eminence is designed to provide substitution for the posterior cruciate ligament if it is not present or cannot be preserved. The subject insert provides approximately 37 percent more constraint than the predicate Duracon® AP Lipped Tibial Insert, without any increase in rotational constraint.
The subject insert does not feature a support post. This allows the Duracon® Condylar Stabilizing (CS) Lipped Tibial Insert to be used with the Duracon® Condylar Femoral Components. These condylar femoral components do not require the removal of additional bone from the distal surface of the femur. Because this insert does not feature a support post, it may also be used in situations where the posterior cruciate ligament is present. The geometry of the insert will accommodate the PCL if it is present.
The subject Duracon® CS Tibial Insert features the same locking mechanism as the previously released Duracon® Condylar and AP Lipped Tibial Insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
The contraindication "Skeletally immature patients" implies the device is indicated for skeletally mature patients.
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)
Testing was presented to characterize the function of the subject tibial insert, and to demonstrate substantial equivalence to other legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Duracon® AP Lipped Tibial Insert
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
p//3 K021451
Duracon® CS Lipped Tibial Insert_ Confidential
510(k) Premarket Notification
OCT 1 8 2002
| 510(k) Summary | |
|---|---|
| Submission Information | |
| Name and Address of Sponsor: | Howmedica Osteonics Corp. |
| 59 Route 17 | |
| Allendale, NJ 07401 | |
| For Information contact: | Margaret F. Crowe |
| Regulatory Affairs Consultant | |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401 | |
| Device Identification | |
| Proprietary Name: | Duracon® CS Tibial Insert |
| Common Name: | Polyethylene Tibial Insert |
| Classification Name and Reference: | Knee Joint Patellofemorotibial |
| Polymer/Metal/Polymer Semi-Constrained | |
| Cemented Prosthesis | |
| 21 CFR §888.3560 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | OR(87) |
| JWH | |
| Prosthesis, Knee Patellofemorotibial, Semi- | |
| Constrained, Cemented, Polymer/Metal/ Polymer |
The Duracon® CS (Condylar Stabilizing) Tibial Inserts are intended to be used with Duracon® Universal and Cruciform tibial baseplates, Duracon® Cruciate Retaining femoral components and Duracon® patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized.
2
1
Duracon® CS Lipped Tibial Insert Confidential
This tibial insert may also be used in situations where the posterior cruciate ligament is present - its geometry will accommodate that ligament. More specific indications and contraindications are listed below:
Indications
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic I arthritis or avascular necrosis,
- 트 Rheumatoid arthritis,
- 지 Correction of functional deformity,
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral . erosion, dysfunction or prior patellectomy; and,
- . Irreparable fracture of the knee
Contraindications
Absolute contraindications include:
- 트 Overt infection,
- Distant foci of infections (which may cause hematogenous spread to the implant site), 대
- Rapid disease progression as manifested by joint destruction or bone absorption T apparent on roentgenogram,
- . Skeletally immature patients
- Cases where there is poor bone stock which would make the procedure unjustifiable, 피 Conditions presenting an increased risk of failure include:
- Uncooperative patient or patient with neurological disorders who is incapable of . following instructions,
- Osteoporosis, .
- Metabolic disorders which may impair bone formation,
- 내 Osteomalacia, and
- Previous arthrodesis
The subject Duracon® CS Tibial Insert is an ultra-high molecular weight polyethylene tibial insert designed to be used with the femoral, tibial, and patellar components of the
2
K021451
Duracon® CS Lipped Tibial Insert______________________________________________________________________________________________________________________________________________ Confidential
510(k) Premarket Notification
Duracon® Total Knee System. This insert is available in small, medium, large, and extralarge sizes in the following thicknesses: 9mm, 11mm, 16m, 19mm, 22mm, and 25mm. The subject insert has a dished articulating surface geometry to provide anatomic rollback, flexion-extension and internal-external rotation. The subject tibial insert features a raised anterior eminence designed to provide greater anterior constraint in situations where the posterior cruciate ligament is not present or not functional. This anterior eminence is designed to provide substitution for the posterior cruciate ligament if it is not present or cannot be preserved. The subject insert provides approximately 37 percent more constraint than the predicate Duracon® AP Lipped Tibial Insert, without any increase in rotational constraint.
The subject insert does not feature a support post. This allows the Duracon® Condylar Stabilizing (CS) Lipped Tibial Insert to be used with the Duracon® Condylar Femoral Components. These condylar femoral components do not require the removal of additional bone from the distal surface of the femur. Because this insert does not feature a support post, it may also be used in situations where the posterior cruciate ligament is present. The geometry of the insert will accommodate the PCL if it is present.
The subject Duracon® CS Tibial Insert features the same locking mechanism as the previously released Duracon® Condylar and AP Lipped Tibial Insert.
Testing was presented to characterize the function of the subject tibial insert, and to demonstrate substantial equivalence to other legally marketed devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401
Re: K021451
Trade/Device Name: Duracon® CS Lipped Tibial Insert Regulation Number: 21 CFR §888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH
Dated: August 2, 2002 Received: August 5, 2002
Dear Ms. Crowe:
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.
4
Page 2 - Ms. Margaret F. Crowe
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark N McKesson
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
5
Duracon® CS Lipped Tibial Insert 510(k) Premarket Notification Confidential
510(k) Number (if known): KO2(45)
Duracon® CS Lipped Tibial Insert Device Name:
The Duracon® CS (Condylar Stabilizing) Tibial Inserts are intended to be used with Duracon® Universal and Cruciform tibial baseplates, Duracon® Cruciate Retaining femoral components and Duracon® patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized. Because this insert does not incorporate a support post, it can accommodate the posterior cruciate ligament if it is present. More specific indications/contraindications are listed below:
Indications
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic I arthritis or avascular necrosis,
- Rheumatoid arthritis,
- 비 Correction of functional deformity,
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral 미 erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR 801.109)
Over the Counter Use - per CFR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -