PWS_KLS Martin_FY25_v1.docx
DOCX document 22 KB Posted
- Attached to
- Consumables for Bone Fixtures
- Solicitation number
- 1301236943
About this file
This Performance Work Statement (PWS) outlines a sole-source contract for the Naval Medical Research Unit San Antonio (NAMRU-SA) to procure the KLS-Martin SonicWeld bone fixing system. The contract requires 19 sterile mesh pieces, 28 packs of sterile pins, 10 twist drills, 14 sterile battery packs, and 2 handpieces with cables. The system is FDA-approved, uses resorbable plates and pins, and employs ultrasonic vibrations to attach bone fragments, with the primary purpose of supporting research by providing a predicate device for comparing a new bone-fixing technology.
The contract is anticipated to be a 12-month base period for FY25, with no option years, and will be awarded to KLS-Martin L.P. of Jacksonville, FL. The delivery location is NAMRU-SA at JBSA Fort Sam Houston, TX, with performance occurring Monday through Friday during standard business hours. Evaluation factors will include Past Performance, Technical Approach, and Price. No security clearance is required, and the effort is unclassified. The technical point of contact is Dr. Nancy J. Millenbaugh, and the contract point of contact is Ms. Abigail Z. Johnston.
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| File | Type | Posted |
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| JA_KLSMartin_FY2025_v2 -JS-ACO signed_1.pdf |
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NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO
PERFORMANCE WORK STATEMENT
Date: November 07, 2024
Single Delivery for Resorbable Plating System with Consumables.
1. Scope of Work.
Naval Medical Research Unit San Antonio (NAMRU-SA) requires a contract for supply of a device/system that meets these requirements: 1) is US Food and Drug Administration (FDA) approved, 2) holds broken bones in place in the face, 3) is resorbable by the body, and 4) utilizes ultrasonic waves to adhere material to the bone. Such a device/system is vital to research being performed as a comparison to a new product being evaluated by NAMRU-SA researchers. The contract device will act as an FDA-approved predicate to support the approval of the new device. The contract needs to cover the cost of the shipping, consumables (pins and mesh) and accessories (handpieces, drill bits, battery packs) of the bone fixing system.
2. Definitions and Terms.
The KLS-Martin L.P. SonicWeld system uses moldable, plastic plates and pins to attach broken bones together to heal in the correct place. The plates and pins are degradable by the body. The pins are unique by melting into pilot holes through a handpiece that delivers ultrasonic vibrations. This system decreases surgical time, the amount of equipment needed, and the potential for complications.
3. Support Requirements.
The contract needs to cover the cost of the shipping, consumables (pins and mesh), and accessories (handpieces, drill bits, battery packs) of the bone fixing system. The contract should supply NAMRU-SA with: 19 individual, sterile mesh pieces, 18 5-packs of sterile pins, 10 2-packs of sterile pins, 10 twist drills, 14 sterile battery packs, and 2 handpieces with cables.
4. Additional Requirements/Qualifications.
Evaluation factors will be based on Past Performance, Technical Approach, and Price.
5. Place and Period of Performance, Workdays and Travel.
1. Period of Performance: The period of performance for this contract is anticipated to be a period of 12 months. The period performance will begin after the contact has been awarded for a 12-month period.
1. Place of Performance: Naval Medical Research Unit San Antonio (NAMRU-SA), 3650 Chambers Pass, Bldg 3610, JBSA Fort Sam Houston, TX 78234
1. Workdays: Monday – Friday (0800-1600)
1. Travel: None.
6. Restrictions. None.
7. Security Clearance. None required; the effort is unclassified.
8. Delivery Address.
Naval Medical Research Unit San Antonio (NAMRU-SA) 3650 Chambers Pass Bldg 3610 JBSA Fort Sam Houston, TX 78234 ATTN: Dr. Nancy J. Millenbaugh Phone: 210-383-3114
9. Contract Period of Performance.
The period of performance is the date of award through a 12-month base period.
10. Points of Contact.
| Technical POC | Contract POC | ||
| Dr. Nancy J. Millenbaugh | Ms. Abigail Z. Johnston | ||
| Phone: 210-383-3114 (cell) | Phone: (210) 539-6252 | ||
| Email: nancy.j.millenbaugh.civ@health.mil | Email: Abigail.z.johnston.civ@health.mil |
| FY ’25 | 1 | |
| FY ’25 | 2 |
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