CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER

K962215 · U.S. Medical Products, Inc. · HWE · Aug 15, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962215
• Device Name: CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
• Applicant: U.S. Medical Products, Inc.
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

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.

Device Story

Manual surgical instrument system; used for bone resection in distal femur. Components: stainless steel template (17-4PH SS @ H900) placed on femur; router bit (17-4PH SS @ H900) with plastic handle (Ultem® 4000) acting as journal bearing. Surgeon attaches flexible shaft to standard OR power drill (Stryker, 3M, etc.) via Zimmer fitting. Template guides router bit; flange on router body stabilizes against torsional forces. Used in OR by orthopedic surgeons. Facilitates proper fit of posterior stabilized tibial insert spine; ensures anatomical alignment for knee replacement.

Clinical Evidence

No clinical data provided; bench testing only. Risk analysis performed; no failure modes exceeded risk index threshold.

Technological Characteristics

Materials: 17-4PH stainless steel (H900) for template and router bit; Ultem® 4000 plastic for router body/handle. Energy source: external OR power drill. Form factor: template with central groove; router with journal bearing handle. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for removal of intercondylar bone from the distal femur to accommodate the spine of a posterior stabilized tibial insert during knee arthroplasty procedures.

Regulatory Classification

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.

Predicate Devices

• Whiteside ORTHOLOC II Posterior Stabilized End Mill and Template
• Intermedics Orthopedics® Natural Knee II System Posterior Stabilized Router Assembly

Submission Summary (Full Text)

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AUG 15 1996
K962215

# 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 Ellen Freddo
Director, Quality Systems and Regulatory Affairs
Voice [phone]
Fax [phone]
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 |