(66 days)
Whiteside ORTHOLOC II Posterior Stabilized End Mill and Template, Intermedics Orthopedics® Natural Knee II System Posterior Stabilized Router Assembly
Not Found
No
The description details a mechanical surgical instrument (router and template) for bone removal, with no mention of software, algorithms, data processing, or any characteristics indicative of AI/ML.
No.
The device is used to remove bone during knee surgery, which is an instrument for a surgical procedure and not a therapeutic device.
No
The device is described as a surgical tool (router) used to remove bone during knee replacement surgery, not to diagnose a condition or disease.
No
The device description clearly details physical components made of stainless steel and plastic, designed for surgical use with a power drill. It is a hardware-based surgical instrument, not software.
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 procedure performed on the patient's bone (distal femur) to prepare it for a knee implant. This is an in vivo procedure, not an in vitro test performed on samples outside the body.
- Device Description: The device is a surgical instrument (router and template) designed for mechanical manipulation of bone tissue during surgery. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the Consensus® Posterior Stabilized Knee system router device is a surgical instrument used in an in vivo procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Consensus® Posterior Stabilized Knee system employs a router device to remove the intercondylar bone from the distal portion of the femur. This bone must be removed to accommodate the spine of the posterior stabilized tibial insert. This procedure occurs after all bone resections of the distal femur have been completed in the traditional manner with the existing Consensus® Knee instruments.
Product codes
Not Found
Device Description
A template is placed on the distal femur. This template is made from stainless steel (17-4PH SS @ H900). The template contains a central groove with adequate markings that ensure proper guidance of the router.
The router itself consists of a router bit (17-4PH SS @ H900), the shank of which is encased in a plastic body (Ultem® 4000) that acts as a handle for the surgeon and as a journal bearing for the shaft of the router bit.
The base of the body has a large diametrical flange that rests on the superior surface of the template. This flange acts to stabilize the router against torsional forces created by the router bit. The superior end of the router shank is attached to a standard flexible shaft. A standard Zimmer fitting is integrally machined to the superior side of the flexible shaft in order to accommodate a standard operating room power drill (Stryker, 3M, etc.).
The router body and bit are available in one size. The template is available in three sizes; size 1/2, size 3/4, and size 5/6. This accommodates the range of Consensus® Knee posterior stabilized femoral components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal portion of the femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, operating room
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)
Performance Data: No performance data exists for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Whiteside ORTHOLOC II Posterior Stabilized End Mill and Template, Intermedics Orthopedics® Natural Knee II System Posterior Stabilized Router Assembly
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
AUG 1 5 1996
ATTACHMENT VII
Summary of Safety and Effectiveness 510(k) SUMMARY Consensus® Posterior Stabilized Knee-Intercondylar Notch Router
US MEDICAL PRODUCTS®, INC.
US Medical Products, Inc. 12201 Technology Blvd. Suite 100 Austin, Texas 78727
Mary Eilen Freddo Director, Quality Systems and Regulatory Affairs Voice (512) 257-4835 Fax Date of Preparation: Tuesday, May 28, 1996
Trade Name:
Consensus® Posterior Stabilized Knee-Intercondylar Notch Router
Common Name: Intercondylar Notch Router
Classification Name:
Substantial Equivalence:
Whiteside ORTHOLOC II Posterior Stabilized End Mill and Template
Intermedics Orthopedics® Natural Knee II System Posterior Stabilized Router Assembly
Device Description: A template is placed on the distal femur. This template is made from stainless steel (17-4PH SS @ H900). The template contains a central groove with adequate markings that ensure proper guidance of the router.
The router itself consists of a router bit (17-4PH SS @ H900), the shank of which is encased in a plastic body (Ultem® 4000) that acts as a handle for the surgeon and as a journal bearing for the shaft of the router bit.
The base of the body has a large diametrical flange that rests on the superior surface of the template. This flange acts to stabilize the router against torsional forces created by the router bit. The superior end of the router shank is attached to a standard flexible shaft. A standard Zimmer fitting is integrally machined to the superior side of the flexible shaft in order to accommodate a standard operating room power drill (Stryker, 3M, etc.).
1
The router body and bit are available in one size. The template is available in three sizes; size 1/2, size 3/4, and size 5/6. This accommodates the range of Consensus® Knee posterior stabilized femoral components.
Intended Use: The Consensus® Posterior Stabilized Knee system employs a router device to remove the intercondylar bone from the distal portion of the femur. This bone must be removed to accommodate the spine of the posterior stabilized tibial insert. This procedure occurs after all bone resections of the distal femur have been completed in the traditional manner with the existing Consensus® Knee instruments.
Summary of Technological Characteristics:
Summary of Risk Analysis: The risk analysis showed that none of the possible failure modes resulted in a risk index greater than 10. According to the scale, no additional action is required to address risk and/or hazards resulting from the use of this device. Preventative measures that are incorporated into the design are shown on the risk analysis of Section _
Performance Data: No performance data exists for this device.
| Clinical Data: | None Required |
|---|---|
| Conclusions from Non-clinical and Clinical Data: | None Required |
| Other Necessary Information: | None Required |