36C25526Q0292 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

NA

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 To all Offerors/Bidders

36C25526Q0292 08-12-2026

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 08-26-2026 11:00 am CDT See CONTINUATION Page X Stryker System 9 Tools - St. Louis - JC Div

The purpose of this amendment is to update deliver instructions and remove CLINs from the Statement of Requirements

(SOR).

Schedule and Please see updated SOR, noted in red font and strikethrough, and Price Schedule for changes.

Please make sure that you refer to the Original RFQ for the required documents submission , failure to provide those items in the RFQ will be considered "Non-Responsive".

Betty Flores Contracting Officer

CONTINUATION PAGE

A.1 STATEMENT OF REQUIREMENTS

Project Title: Procurement of Stryker System 9 Power Tools, Batteries, Attachments, and Accessories

1.0 Purpose

The purpose of this Statement of Requirements (SOR) is to outline the requirements for the procurement of Stryker System 9 surgical power tools, attachments, batteries, chargers, and associated components to support surgical operations at the VA St. Louis Health Care System. The identified equipment will replace aging instrumentation and provide reliable, high‑performance orthopedic power systems for operative use.

2.0 Background

The VA St. Louis Health Care System currently utilizes Stryker surgical power equipment. Due to equipment age, increased demand, and required modernization of surgical instrumentation, replacement and expansion of System 9 tool sets and related components are necessary.

3.0 Scope of Work

The Contractor must provide all equipment, accessories, and materials listed in. All equipment must be new and meet OEM specifications.

The Contractor must ensure all items arrive in manufacturer‑sealed packaging and include all standard OEM warranties.

4.1 Equipment and Components

The Contractor shall supply the following general categories of Stryker System 9, TPX, and Core 2 surgical power equipment and associated accessories, including but not limited to:

System 9 Power Tools and Handpieces

· System 9 Sagittal Saw — 15 EA

· System 9 Reciprocating Saw — 10 EA

· System 9 Dual Trigger Rotary Handpiece — 10 EA

· System 9 Cordless Driver Handpiece — 4 EA

· System 9 Sabo Sagittal Saw — 4 EA

· System 9 Sternum Saw — 4 EA

System 9 Batteries, Chargers, and Battery Containers

· System 9 Large Batteries — 30 EA

· System 9 Small Batteries — 20 EA

· System 9 Sterile Battery Charger (with NEMA Power Cord) — 6 EA

· Sterile Battery Container Bundle, Large — 10 EA

· Sterile Battery Container Bundle, Small — 6 EA

System 9 Collets, Chucks, and Attachments

· Dual Trigger Pin Collet — 10 EA

· Dual Trigger Wire Collet — 10 EA

· Locking Keyless Chuck (1/4") — 10 EA

· Keyed Chuck (1/4") — 10 EA

· AO Small Attachment — 10 EA

· AO Large Reamer Attachment — 10 EA

· Hudson Attachment — 10 EA

· Hudson/Modified Trinkle Attachment — 10 EA

· Sternum Blade Guard — 4 EA

TPX Series Components

· TPX Sagittal Saw — 4 EA

· TPX Reciprocating Saw — 4 EA

· TPX Micro Drill — 4 EA

· TPX Universal Driver — 4 EA

· TPX Handswitch — 8 EA

· TPX Cables — 8 EA

TPX Collets, Drills, and Attachments

· Adjustable Pin Collet (2.0–3.2mm) — 8 EA

· Wire Collet — 8 EA

· 1/4" Drill with Key — 8 EA

· 5/32" Drill with Key — 4 EA

· AO Small Drill — 8 EA

· Microdrill Straight Attachment — 4 EA

Core 2 System

· Core 2 – United States — 3 EA

Sterile Containers and Bundles

· Handpiece Solid Container Bundle — 10 EA

· Cordless Driver & SABO Solid Container Bundle — 4 EA

· Hybrid Solid Container Bundle — 4 EA

· Container with Solid Bottom Kit — 4 EA

All items shall be new, meet OEM specifications, be delivered in manufacturer-sealed packaging, and include all standard OEM warranties.

4.2 Salient Characteristics

To satisfy the Government's minimum need, the equipment must possess the following essential characteristics:

Handpieces

· Dedicated handpieces (cordless driver, sagittal saw, reciprocating saw, rotary drill/ream, SABO saw, sternum saw, and precision saw) that reduce time spent changing attachments during procedures.

· Rotary handpiece with integrated drill/ream switch, minimum 157 in/lbs of torque, approximately 1,200 rpm in drill mode and 270 rpm in ream mode, weighing less than 2.4 lbs.

· Reciprocating saw capable of up to 13,000 cuts per minute (fast mode) and 10,000 cuts per minute (standard mode), weighing less than 2.3 lbs.

· Sagittal saw capable of up to 12,000 cuts per minute (fast mode) and 10,000 cuts per minute (standard mode), weighing less than 2.4 lbs.

· Precision saw with stationary blade shaft and oscillating blade tip (to reduce arc of excursion, skive, dive, and cut-guide wear), capable of up to 16,000 cuts per minute (fast mode) and 12,000 cuts per minute (standard mode), weighing less than 2.5 lbs., and compatible with proprietary precision cartridges.

· Cordless driver compatible with legacy 4100, 4505, and 4405 attachments.

· Fully submersible handpieces with an IPX9 rating, durable coating to withstand repeated washing/sterilization, intuitive handpiece-to-battery connection with audible and tactile feedback, and a safety-bar design that eliminates accidental actuation.

· Sternum saw with ergonomic handle design to reduce pressure points and accommodate inverted cutting techniques.

Battery and Charging

· Lithium-ion cell chemistry with no memory effect and consistent full performance throughout the discharge cycle.

· Batteries interchangeable across System 9 large and medium bone handpieces.

· Battery indicator light and the ability to confirm charge immediately before surgical use.

· Approved for both steam and Sterrad (Sterrad/hydrogen peroxide) sterilization.

· Laser-welded, sealed construction to prevent liquid ingress/egress; autoclave abuse detection; active cell protection; improved insulation for thermal protection; and continuous self-monitoring for safe operation.

· Flexible charging capabilities and sterile battery transfer that maintains the sterile field.

Attachments and Compatibility

· Handpieces must accept the full range of System 9 collets (pin, wire, adjustable), chucks (keyed and keyless), and drill, reamer, Hudson, Modified Trinkle, and AO attachments via the standard quick-connect interface.

· Backward compatible with legacy cutting accessories and with legacy System 6, 7, and 8 attachments.

· Saws must accept OEM cutting accessories/blades appropriate to orthopedic and sternotomy procedures.

Sterilization and Containers

· All handpieces, attachments, batteries, and trays must be designed and approved for automated machine-washing.

· Sterilization cases with automated-washer-compatible inserts and instructional/display brackets, compatible with existing System 7 sterilization containers and insert trays.

· Sterile container bundles and solid-bottom kits sized and configured to house the corresponding System 9, TPX, cordless driver/SABO, and battery components and to integrate with existing facility sterile-processing equipment and workflows.

Device Management

· Remote/smart equipment management (SEM) capability providing device usage data, usage patterns and trends, inventory tracking, service and maintenance history, off-line device notification, near-real-time reporting, data export, and predictive maintenance modeling.

Regulatory Compliance

· All items must be new (not refurbished), current-production medical devices delivered with full OEM warranty and current labeling.

· Battery-powered equipment must meet the applicable FDA classification for this device type — Class I under 21 CFR § 878.4820 (product code HWE), exempt from premarket notification [510(k)] requirements — and be supplied by an FDA-registered manufacturer (FDA Registration No. 1811755).

4.3 Delivery Requirements

· Delivery must be:

VA St. Louis Health Care System: John Cochran Division 915 N Grand Blvd St. Louis, MO 63106 ATTN: Biomedical Engineering

The Contractor shall contact the designated point of contact (POC) and schedule delivery before shipping any supplies. Before shipment, the Contractor shall provide the anticipated delivery date and time, carrier information, tracking number or bill of lading number, and the approximate gross weight and external dimensions, length, width, and height of each package, pallet, crate, or other shipping container.

The Contractor shall obtain confirmation of the estimated delivery date, time, and receiving location before releasing the shipment to the carrier.

The Government will not accept partial shipments without prior written approval from the Contracting Officer or designated VA/VHA representative. Unauthorized partial shipments may be refused or returned at the Contractor’s expense. The Contractor remains responsible for complete delivery of all ordered items in accordance with the applicable purchase order or delivery order.

5.0 Contractor Responsibilities

The Contractor shall:

1. Plan and schedule all deliveries with the facility prior to shipping.

2. Deliver all items in new condition with full manufacturer warranty.

3. Provide tracking and shipment information upon dispatch.

4. Notify the Contracting Officer and end‑user of delays or backorders.

6.0 Government Responsibilities

The VA St. Louis Health Care System will:

1. Provide delivery access and receiving support.

2. Inspect shipments for accuracy and condition.

3. Process acceptance and invoice payments under the terms of Net 30.

7.0 Security Requirements

No IT, data security, or system access is associated with this procurement. No HIPAA‑sensitive data is exchanged.

9.0 Acceptance Criteria

Equipment will be accepted when:

· All listed items are delivered in correct quantities

· Items are free from damage

· Serial and model numbers match packing documentation

· OEM warranty information is provided

A.2 PRICE/COST SCHEDULE

ITEM INFORMATION

MPN: 9208-000-000

PSC: 6515

PSC: 6515

MPN: 9205-000-000

PSC: 6515

MPN: 8203-126-000

PSC: 6515

MPN: 8203-026-000

PSC: 6515

MPN: 8203-133-000

PSC: 6515

MPN: 6203-131-000

PSC: 6515

MPN: 6203-110-000

PSC: 6515

MPN: 6203-135-000

PSC: 6515

PSC: 6515

MPN: 6203-113-000

PSC: 6515

MPN: 4605-000-000

PSC: 6515

PSC: 6515

PSC: 6515

MPN: 4100-062-000

PSC: 6515

MPN: 4100-132-000

PSC: 6515

MPN: 4100-110-000

PSC: 6515

MPN: 5100-015-000

PSC: 6515

PSC: 6515

MPN: 4100-062-000

PSC: 6515

MPN: 4100-110-000

PSC: 6515

MPN: 5400-052-000US

PSC: 6515

MPN: 7102-654-000

PSC: 6515

MPN: 4405-652-000

PSC: 6515

PSC: 6515

MPN: 9110-120-000US

PSC: 6515

MPN: 9215-000-000

PSC: 6515

MPN: 9400-554-000

PSC: 6515

MPN: 9212-000-000

PSC: 6515

MPN: 9400-454-000

PSC: 6515

MPN: 9207-000-000

PSC: 6515

MPN: 7207-003-000

PSC: 6515

MPN: 7102-653-000

PSC: 6515