36C24625Q0847_1.docx

Special Notice Special Notice

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

POINT OF CONTACT*

Stephen Nassan Contract Specialist stephen.nassan@va.gov

ADDITIONAL INFORMATION

DESCRIPTION

The Department of Veterans Affairs, Network Contracting Office (NCO) 6, intends to negotiate a sole source contract with INNOVATIVE MEDICAL PRODUCTS, INC.

This requirement is for Modular Knee Positioners at the Richmond VAMC, 1201 Broad Rock Blvd, Richmond, VA 23249. The machine must meet the following minimum Salient Characteristics:

Knee Positioner – Salient Characteristics What It Is:

A Precision Knee Positioner is a specialized surgical device used in orthopedic procedures, particularly total knee arthroplasty (TKA) and other knee surgeries. It is designed to stabilize and manipulate the patient's leg during surgery, providing optimal exposure and consistent positioning of the knee joint.

What It Does:

Stabilizes the Leg: Secures the leg and maintains consistent alignment throughout the procedure.

Allows Controlled Movement: Enables surgeons to flex, extend, rotate, or lock the knee in specific positions to access different anatomical structures with precision.

Enhances Surgical Accuracy: Assists in maintaining consistent limb alignment and joint exposure, improving implant placement and surgical outcomes.

Improves Efficiency and Ergonomics: Reduces the need for manual holding by surgical staff, minimizing fatigue and allowing for better workflow in the operating room.

What It Looks Like:

Typically consists of a metal or radiolucent frame mounted to the surgical table.

Features adjustable padded supports or cradles to hold the thigh, calf, and foot securely.

Includes mechanical arms or hinges that allow for controlled movement of the leg in multiple planes.

Some models are equipped with quick-release locks, angle indicators, or motorized components for precision adjustments.

The design is compact, sturdy, and often modular to accommodate different patient anatomies and surgical techniques.

Physical Characteristics:

1. Soft Tissue Protection The device shall include high-density padding and foam-lined contact surfaces that conform to the patient’s anatomy.

The device shall include cushioned leg and femoral support specifically designed to distribute weight evenly to reduce the risk of neurovascular compression.

2. Stability The device shall contain a multi-point fixation design.

The femoral and distal leg cradles shall be mounted on a rigid base platform that resists lateral movement and rotational drift.

The device shall use a non-slip surface interface and clamping to the surgical table rail.

3. Adjustability The device allows for multi-axis adjustability, enabling controlled manipulation of flexion, extension, abduction, adduction, and rotation. Range of motion typically spans:

0° to 135° flexion ±20° abduction/adduction Internal/external rotation up to 20° The device shall make adjustments electronically using a footswitch or handheld controller without manual locking or physical readjustment.

4. Locking Mechanism

The positioner shall use a spring-loaded, cam-style locking mechanism that allows for quick engagement and secure hold of the limb at any point along its range of motion.

The locking system shall be actuated via a single-hand or foot-activated release.

The mechanism shall ensure zero drift once engaged and is designed for tool-free operation.

5. Radiolucency The leg support and cradle system shall be constructed from radiolucent polymer composites, allowing for clear intraoperative fluoroscopic imaging without obstruction.

Imaging shall be able to be taken at 90° knee flexion in the axial and lateral planes, and the material composition does not interfere with X-ray or C-arm visibility.

6. Surgical Efficiency The system shall be designed for no more than 2–3 assembly steps.

The entire apparatus shall be capable of being affixed to the operating table rail via a universal clamp system, with alignment guides and quick-connect components reducing pre-op configuration time.

Thae device shall contain preset angle indicators and sterile draping compatibility.

Period of performance will be for the period 15 October 2024 through 14 October 2025.

Justification for this sole source procurement is in accordance with FAR 13.106-1(b)(2) soliciting from a single source.

This notice of intent is not a request for competitive quotes. No solicitation documents are available, and telephone requests will not be accepted. However, any business that believes it can meet these requirements may give written notice. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Responses will be considered by the Government, however, a determination by the Government not to compete the proposed acquisition based upon responses of this notice is solely within the discretion of the Government.

NAICS Code 339112/ 1000 employees.

Responses received by 12:00 pm est on 7 July 2025 will be considered by the Government. Inquiries shall be emailed to stephen.nassan@va.gov. No telephone request will be accepted.

Special Notice