The ORTHOLOC® 3Di Foot Plating Reconstruction 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)

Device Description

The ORTHOLOC® 3Di Foot Reconstruction System Line Extension (ORTHOLOC® 3Di CrossCHECK Module) is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The implants included in this system are designed to provide highly anatomic and versatile plating options for an array of fusions and stabilizations. The plates include straight, right, and left configurations, as well as locking and non-locking screws.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the ORTHOLOC® 3Di Foot Plating Reconstruction System. This document focuses on demonstrating the substantial equivalence of the new device to previously approved predicate devices, primarily through non-clinical performance testing. It does not describe a study involving a device that uses artificial intelligence (AI), machine learning (ML), or any software-based diagnostic or prognostic capabilities that would require acceptance criteria related to accuracy, sensitivity, specificity, or reader studies.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this particular submission.

Here's an analysis based on the available information:

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

Acceptance Criteria Type	Acceptance Criteria	Reported Device Performance
Non-Clinical	Substantial equivalence in material, size, and bending strength to predicate devices.	Performance testing and analysis demonstrated substantial equivalence in static bending to predicate devices.
Material/Design	Comprised of titanium plates with various shapes and sizes.	Confirmed. The device consists of titanium plates in various configurations.
Intended Use	Stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet.	The device's indications for use align with this, detailing specific mid/hindfoot fusions, osteotomies, and fracture fixations.

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

Sample Size: The document does not specify a "sample size" in the context of clinical data or patient outcomes, as the assessment was based on non-clinical engineering performance testing (static bending). For the non-clinical testing, the sample size would refer to the number of physical devices or components tested. This information is not explicitly provided in the summary.
Data Provenance: Not applicable, as this was non-clinical engineering testing, not human data.

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)

Not applicable. The ground truth for engineering performance testing (e.g., bending strength) is established by engineering standards and measurement equipment, not clinical expert consensus.

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

Not applicable. Adjudication methods are typically for clinical studies with expert reviewers, not non-clinical engineering tests.

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

No, an MRMC comparative effectiveness study was not done. This device is a metallic bone fixation appliance, not an AI-powered diagnostic or decision support system.

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

Not applicable. This device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance assessment was established through engineering standards and measurements (e.g., measuring static bending strength) in comparison to established performance of predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection.

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

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

December 11, 2015

Re: K152974

Trade/Device Name: ORTHOLOC® 3Di Foot Plating Reconstruction 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: September 26, 2015 Received: October 13, 2015

Dear Val 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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.

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K152974

Device Name

ORTHOLOC® 3Di Foot Plating Reconstruction System

Indications for Use (Describe)

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 of the word "WRIGHT" in red, all caps. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.

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 ORTHOLOC® 3Di Foot Plating Reconstruction System – Line Extension.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	October 2, 2015
Contact Person:	Val MylesRegulatory Affairs SpecialistOffice - (901) 290-5162Fax — (901) 867-4190
(a)(2). Proprietary Name:	ORTHOLOC® 3Di Foot PlatingReconstructionSystem - Line Extension
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:	K151442: TOTAL COMPRESSION PLATINGSYSTEMK132594: CrossCHECK Plating SystemK120359: ORTHOLOC® 3Di Hallux SystemK121651: ORTHOLOC® 3DiMidfoot/Flatfoot System

(a)(4). Device Description

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(a)(5). INTENDED USE

The ORTHOLOC® 3Di Foot Reconstruction 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 devices included in ORTHOLOC® 3Di Foot Reconstruction System Line Extension are technologically substantially equivalent to predicate devices in material, size, and bending strength.

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

Performance testing and analysis demonstrated substantial equivalence in static bending.

(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 as well as the predicate devices.

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.