(66 days)
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.
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.
This document is a 510(k) summary for a medical device called the Consensus® Posterior Stabilized Knee-Intercondylar Notch Router. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document explicitly states:
- "No performance data exists for this device."
- "Clinical Data: None Required"
- "Conclusions from Non-clinical and Clinical Data: None Required"
Therefore, I cannot provide the requested information. The submission appears to be based on substantial equivalence to predicate devices rather than new performance data.
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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.).
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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 |
§ 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.