· Bi-Cortical osteotomies in the foot
Distal metatarsal osteotomies
· Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.)

Device Description

The PROSTEP TBC Implant System is intended for use in bone reconstruction and osteotomy of the first metatarsal. The implants are provided sterile and consist of one PROSTEP TBC implant, one MICA screw, and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.

AI/ML Overview

This document describes the PROSTEP TBC Implant System, a medical device for bone reconstruction and osteotomy of the first metatarsal. It is a 510(k) summary, which means no specific acceptance criteria or study details regarding device performance against such criteria are provided in the given text.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical evidence, rather than presenting a study proving performance against defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to clinical or performance studies that are not included here.

Here's what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria nor does it report specific device performance metrics against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The substantial equivalence is based on non-clinical testing (static and fatigue construct testing, bacterial endotoxin assessments), not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. No clinical test set with ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. No clinical test set with adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is an implantable system, not an AI or algorithm-based device. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As no clinical study with a test set is described, no specific ground truth type is mentioned. For the non-clinical testing, the "ground truth" would be the engineering specifications and performance standards for static, fatigue, and bacterial endotoxin assessments.

8. The sample size for the training set

This is not applicable as the document describes a physical implant system, not a machine learning model.

9. How the ground truth for the training set was established

This is not applicable as the document describes a physical implant system, not a machine learning model.

Summary based on available information:

Detail	Information from Document
Acceptance Criteria and Reported Device Performance	Not explicitly stated in terms of specific performance metrics against defined acceptance criteria for a study. The document focuses on establishing substantial equivalence based on technological characteristics and non-clinical testing. It states: "The subject was evaluated through static and fatigue construct testing and bacterial endotoxin assessments to support the safety and effectiveness of the subject device system." and "The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate and are substantially equivalent."
Sample size for test set & data provenance	Not applicable for a clinical test set; non-clinical testing (static, fatigue, bacterial endotoxin) was performed, but sample sizes for these tests are not provided. Data provenance is not mentioned.
Number of experts & qualifications for ground truth (test set)	Not applicable; no clinical test set requiring expert ground truth is described.
Adjudication method (test set)	Not applicable; no clinical test set requiring adjudication is described.
MRMC comparative effectiveness study & effect size with/without AI assistance	Not applicable; no MRMC study or AI component is mentioned.
Standalone (algorithm only) performance	Not applicable; this is a physical implant system, not an algorithm.
Type of ground truth used	For non-clinical testing, the "ground truth" would be engineering specifications and performance standards for static and fatigue testing, and accepted methodologies for bacterial endotoxin assessments. No clinical ground truth (e.g., pathology, outcomes data) is used because no clinical study is presented.
Sample size for training set	Not applicable; this is a physical implant system, not a machine learning model.
How ground truth for training set was established	Not applicable; this is a physical implant system, not a machine learning model.

Summary

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June 6, 2019

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Wright Medical Technology, Inc. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K183620

Trade/Device Name: PROSTEP TBC Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 18, 2019 Received: April 25, 2019

Dear Michael Mullins:

We have reviewed your 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183620

Device Name

PROSTEP TBC Implant System

Indications for Use (Describe)

The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include:

· Bi-Cortical osteotomies in the foot
Distal metatarsal osteotomies
· Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.)

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)

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K183620 page 1/2

Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 wmt.com

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 PROSTEP TBC Implant System.

Submitted By:	Wright Medical Technology, Inc.
	1023 Cherry Road
	Memphis, TN 38117
Date:	December 21, 2018
Contact Person:	Michael Mullins
	Regulatory Affairs Specialist II
	Office: (901)867-4142
	Fax: (901)867-4190

(a)(2) SUBJECT DEVICE INFORMATION

(a)(1) MANUFACTURER IDENTIFICATION

Proprietary Name:	PROSTEP TBC Implant System
Common Name:	Single/multiple component metallic bone fixationappliances and accessories / Smooth or threadedmetallic bone fixation fastener
Classification Name & Reference:	21 CFR 888.3040 / 888.3030 - Class II
Device Product Code & Panel:	HRS / HWC - Orthopedic

(a)(3) PREDICATE DEVICE INFORMATION

MICA Screw System (primary)	K162353
ORTHOLOC 3Di Ankle Fracture (reference)	K163044
Mini Maxlock Extreme Plating System (reference)	K120157
ORTHOLOC HALLUX (reference)	K123059

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(a)(4) DEVICE DESCRIPTON

(a)(5) INTENDED USE

The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include:

. Bi-Cortical osteotomies in the foot
Distal metatarsal osteotomies
Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.) ●

(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON

The subject device is a construct that uses cleared components and a new component to address first metatarsal hallux valgus. The subject devices intended use/indications for use is contained within the predicate. The principles of operation are similar to the predicate. Table 1 below shows a comparison of technological characteristics.

	SUBJECT	PREDICATE (primary)
	PROSTEP TBC Implant System	MICA Screws – K162353
Material	ASTM F136	ASTM F136
Implant	PROSTEP TBC: Small, Medium,Large
	MICA Screw: Diameter: 3.0 mmLength: 34-40 mm	Diameter: 3.0mmLength: 20-50mm
	ORTHOLOC 3Di Screw(K163044-reference predicate):
	Diameter: 2.7 mm
	Length: 12-14 mm

Table 1 Subject vs Predicate Technological Comparison

(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE

The subject was evaluated through static and fatigue construct testing and bacterial endotoxin assessments to support the safety and effectiveness of the subject device system.

(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE

N/A

(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS

The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate and are substantially equivalent.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.