PRO-STIM™ resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-STIM™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-STIM™ is provided sterile for single use only.

For the PRO-STIM™ Core Decompression Procedure Kit:

The PRO-STIM™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-STIM™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

Device Description

PRO-STIM is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ via hydration reactions. The subject implant kits consist of pre-measured surgical grade calcium sulfate and calcium phosphate, demineralized bone matrix, pre-measured mixing solution, and the tools necessary to mix the components into a paste and inject the material into the defect site. When the implant components are mixed according to the instructions, an injectable paste is formed.

The subject includes an updated mixing and delivery system for the implant material as well as new size configurations for the kits. The subject accessories include two sizes of syringe mixers (14 mL and 40 mL); a spindle drive for mechanical assist, a larger delivery syringe, and associated cannulas and adaptors.

AI/ML Overview

There is no information in the provided document about acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called PROSTIM™ Injectable Inductive Graft, indicating that the device is substantially equivalent to legally marketed predicate devices.

The information provided describes the device, its intended use, and non-clinical testing performed to establish substantial equivalence, but it does not detail specific acceptance criteria or the full results of a study designed to demonstrate performance against such criteria.

Specifically, the document states:

Non-Clinical Evidence: "Dissolution, vicat set time, and diametral tensile strength (DTS) testing showed that the new syringe mixing and delivery systems produced a resultant graft that met all the material specification of the current PRO-STIM graft. Pyrogenicity testing was also performed."
Clinical Evidence: "N/A" (Not Applicable)
Conclusion: "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices."

This indicates that some material properties were tested against existing specifications for the "current PRO-STIM graft," but the specific acceptance criteria (e.g., exact values or ranges for dissolution, vicat set time, DTS) and the detailed results of those tests are not provided. The document highlights that the new mixing and delivery system produces a graft that meets the specifications of the current graft, rather than detailing a study against new, explicit acceptance criteria for the entire device.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance assays, or ground truth establishment based solely on the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

March 14, 2019

Wright Medical Technology, Inc. Rachel Roberts Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K190283

Trade/Device Name: PROSTIM™ Injectable Inductive Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: February 8, 2019 Received: February 11, 2019

Dear Ms. Roberts:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K190283

Device Name PROSTIM™ Injectable Inductive Graft

Indications for Use (Describe)

PRO-STIM™ is provided sterile for single use only.

For the PRO-STIM™ Core Decompression Procedure Kit:

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PRODENSE™ 2.0 Bone Graft Substitute.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	February 8, 2019
Contact Person:	Rachel RobertsRegulatory Affairs SpecialistOffice - (901) 867-9708Fax - (901) 867-4190
(a)(2). Proprietary Name:	PRO-STIM™ Injectable Inductive Graft
Common Name:	Bone Void Filler
Classification Name and Reference:	21 CFR 888.3045 - Class II
Device Product Code, Device Panel:	MQV, Orthopedic
(a)(3). Predicate Device:	K083270 - WMT Composite DBMK181255 - PRODENSE™ Bone GraftSubstitute

(a)(4). Device Description

(a)(5). INTENDED USE

PRO-STIM resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

{4}------------------------------------------------

The PRO-STIM paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-STIM paste is provided sterile for single use.

PRO-STIM Core Decompression Procedure Kit

The PRO-STIM Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-STIM Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

(a)(6). Technological Characteristics Comparison

The subject implant is identical to that of the predicate. The subject includes an updated mixing and delivery system for the implant material as well as new size configurations for the kits. The subject accessories include two sizes of syringe mixers (14 mL and 40 mL); a spindle drive for mechanical assist, a larger delivery syringe, and associated cannulas and adaptors.

(b)(1). Substantial Equivalence - Non-Clinical Evidence

Dissolution, vicat set time, and diametral tensile strength (DTS) testing showed that the new syringe mixing and delivery systems produced a resultant graft that met all the material specification of the current PRO-STIM graft. Pyrogenicity testing was also performed. The subject 14 mL and 40 mL syringe mixing and delivery systems are acceptable methods for the preparation of the PRO-STIM Injectable Bone Graft.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices.

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.