(149 days)
Not Found
No
The summary describes a mechanical orthopedic implant component (tibial insert) and its intended use in revision surgery. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a medical implant (tibial insert) used to revise an existing knee replacement component, which is a therapeutic intervention for a compromised joint.
No
The device is a replacement orthopedic implant (tibial inserts) used in revision surgery, not a tool for diagnosing medical conditions.
No
The device is a physical implant (tibial inserts) used in knee revision surgery, not a software application. The description focuses on the physical components and their mechanical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a replacement tibial insert for use in knee revision surgery. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description (Not Found): While the description is not available, the intended use strongly suggests a physical implant.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (blood, urine, tissue, etc.).
- Anatomical Site: The device is used within the knee joint, which is an in-vivo application, not an in-vitro one.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is a surgical implant used directly in the patient's body.
N/A
Response:
Intended Use / Indications for Use
The Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial component assembly. These inserts are intended to be used when the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.
Product codes
JWH OR (87)
Device Description
The Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial component assembly. These inserts are intended to be used when the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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
Testing was presented which characterized the contact area and range of constraint for the subject devices, and the attachment strength of the inserts to the baseplates. Comparisons were made to legally marketed devices.
Key Metrics
Not Found
Predicate Device(s)
K823420, K823420, K823420, K936008, K940861
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
510 (k) Summary
960976
AUG - 7 1996
Proprietary Name: Kinematic® II Replacement Tibial Inserts
Tibial Insert - Total Knee System Common Name:
Classification Name and Reference: 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
Proposed Regulatory Class: Class II
Device Product Code: JWH OR (87)
For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7431 (201) 507-6870 Fax:
The Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial These inserts are intended to be used when component assembly. the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.
The Kinematic® II Replacement Tibial Inserts are equivalent to other legally marketed devices in commercial distribution. These devices are:
- Kinematic® II Condylar Cruciate Retaining Tibial 1. Component - Howmedica (K823420)
- Kinematic® II Total Condylar Tibial Component -2 . Howmedica (K823420)
- Kinematic® II Stabilizer Tibial Component -3. Howmedica (K823420)
- P.C.A. Primary Tibial Inserts for Duracon® 4 . Baseplates - Howmedica (K936008)
- P.C.A. Modular Tibial Inserts for Duracon® 5 . Baseplates - Howmedica (K940861)
This equivalence is based upon similarities in intended use, material, and design to the legally marketed devices. Testing was presented which characterized the contact area and range of constraint for the subject devices, and the attachment strength of the inserts to the baseplates. Comparisons were made to legally marketed devices.