The TCP System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

Mid / Hindfoot Fusions

LisFranc Arthrodesis and/or Stabilization
· 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
· Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
· Calcaneo-Cuboid (CC) Fusion
Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

· Opening base wedge osteotomy
· Closing base wedge osteotomy
· Crescentic osteotomy
Proximal Chevron osteotomy
· Distal Chevron osteotomy (Austin)

First metatarsal fracture fixation

Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

· Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
· Revision MTP Fusion
· Revision of failed first MTP Arthroplasty implant

Flatfoot Osteotomies

· Lateral Column Lengthening (Evans Osteotomy)
· Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

Device Description

The TOTAL COMPRESSION PLATING SYSTEM is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. Most of the plates are scalloped in shape to allow easier bending to fit the contour of the bone. There are also nonscalloped plates to provide greater strength. The plates include straight, right, and left configurations.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the TOTAL COMPRESSION PLATING (TCP) SYSTEM. Based on the provided text, there is no study described that involves acceptance criteria for device performance in the context of AI or diagnostic accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes. It states:

No specific acceptance criteria or device performance data are reported. The submission relies on the fact that "The subject TOTAL COMPRESSION PLATING SYSTEM design is identical to the currently marketed TOTAL COMPRESSION PLATING SYSTEM."
No sample size for a test set, data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance are described. This type of information is pertinent to studies evaluating AI or diagnostic device accuracy, which is not the nature of this submission.
The ground truth discussions (for training or test sets) are not relevant here as this is not an AI or diagnostic device.
No sample size for the training set is mentioned.

Instead, the document refers to:

Mechanical testing and engineering analysis that "was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical." This implies that the 'acceptance criteria' for this type of device would typically relate to mechanical properties (e.g., strength, durability, biocompatibility) rather than diagnostic accuracy.
Non-Clinical Evidence as the basis for substantial equivalence, with "N/A" for "Substantial Equivalence Clinical Evidence."

In summary, this 510(k) submission establishes substantial equivalence for a bone fixation plating system by demonstrating that its design is identical to a previously cleared predicate device, and thus relies on the prior mechanical testing and engineering analysis of that predicate. It does not contain information related to acceptance criteria or studies proving performance in the context of accuracy, reader improvement, or AI systems.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three overlapping human profiles facing to the right, creating a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Incorporated Ms. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

September 4, 2015

Re: K151442 Trade/Device Name: TOTAL COMPRESSION PLATING (TCP) 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 Dated: June 22, 2015 Received: June 24, 2015

Dear Ms. Myles:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Val Myles

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

TOTAL COMPRESSION PLATING (TCP) SYSTEM

Indications for Use (Describe)

The TCP System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

Mid / Hindfoot Fusions

LisFranc Arthrodesis and/or Stabilization
· 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
· Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
· Calcaneo-Cuboid (CC) Fusion
Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

· Opening base wedge osteotomy
· Closing base wedge osteotomy
· Crescentic osteotomy
Proximal Chevron osteotomy
· Distal Chevron osteotomy (Austin)

First metatarsal fracture fixation

Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

· Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
· Revision MTP Fusion
· Revision of failed first MTP Arthroplasty implant

Flatfoot Osteotomies

· Lateral Column Lengthening (Evans Osteotomy)
· Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side. To the right of the trapezoids is the word "WRIGHT" in red, and below that is the phrase "FOCUSED EXCELLENCE" in gray.

Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 vmt.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 TOTAL COMPRESSION PLATING SYSTEM.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	May 26, 2015
Contact Person:	Val MylesRegulatory Affairs SpecialistOffice - (901) 290-5162Fax - (901) 867-4190
(a)(2). Proprietary Name:	TOTAL COMPRESSION PLATING (TCP) SYSTEM
Common Name:	Plate, Fixation, Bone
Classification Name and Reference:	21 CFR 888.3030 - Class II
Device Product Code, Device Panel:	HRS - Orthopedic
(a)(3). Predicate Device:	K143025: TOTAL COMPRESSION PLATING(TCP) SYSTEMK121651: ORTHOLOC® 3DiMidfoot/Flatfoot System

(a)(4). Device Description

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(a)(5). INTENDED USE

The TCP System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include:

Mid / Hindfoot Fusions

LisFranc Arthrodesis and/or Stabilization
1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion ●
Medial Column Fusion

First metatarsal osteotomies for hallux valgus correction including:

Opening base wedge osteotomy
Closing base wedge osteotomy ●
Crescentic osteotomy
Proximal Chevron osteotomy
. Distal Chevron osteotomy (Austin)

First metatarsal fracture fixation

Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) Arthrodesis of the first metatarsophalangeal joint (MTP) including:

Primary MTP Fusion due to hallux ridgidus and/or hallux valgus ●
Revision MTP Fusion
Revision of failed first MTP Arthroplasty implant ●

Flatfoot Osteotomies

Lateral Column Lengthening (Evans Osteotomy) .
Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton . Osteotomy)

(a)(6). Technological Characteristics Comparison

The subject TOTAL COMPRESSION PLATING SYSTEM design is identical to the currently marketed TOTAL COMPRESSION PLATING SYSTEM.

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

Mechanical testing and engineering analysis was previously provided in the predicate device filings. Therefore, no testing was provided for the subject device as the design is identical.

(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 device.

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.