The ORTHOLOC™ 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include:

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

Device Description

Wright Medical's ORTHOLOC™ 3Di Hallux System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. The subject plates are modified from the DARCO Locking Bone Plate System (K061808). The system contains 33 plates belonging to 1 of 4 plate styles with various sizes and options, each contoured for specific anatomy and designed for specific procedures. All plates feature polyaxial locking screw holes and k-wire holes, and some plates have nonlocking compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm locking and non-locking screws.

AI/ML Overview

This document describes the ORTHOLOC™ 3Di Hallux System, a bone plate system intended for stabilization and fixation of bones in the feet and toes. The device is a Class II medical device.

1. Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device (K061808 - DARCO Locking Bone Plate System) rather than defining specific quantifiable acceptance criteria related to clinical endpoints (like success rates in fracture healing). Instead, the acceptance criteria are implicitly met by demonstrating that the new design features perform at least as well as, or better than, the predicate device in relevant mechanical tests, and do not introduce new safety or effectiveness concerns.

Acceptance Criteria (Implicit)	Reported Device Performance
Effectiveness of the new polyaxial locking feature	"The subject plate locking mechanism evaluated in this testing was found to be acceptable for off-axis mechanical screw locking up to three times as compared to a non-locking screw."
Strength/performance of the new 2.7 mm non-locking screw	"Torque testing was performed on the subject 2.7 mm non-locking screw and results exceeded the minimum safety factor."
Overall mechanical performance compared to predicate (specifically in bending, and ensuring no "new worst-case" plates)	"Performance testing supports the effectiveness of the new locking feature and the new screw and shows that no new worst-case plates (in bending) are introduced in this system.""Through mechanically validated FEA analysis, the worst-case subject ORTHOLOC™ 3Di plates were found not to represent a new worst-case in bending for any of the four plate families evaluated."
No new questions of safety or effectiveness introduced	"The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness."
Performance at least as well as the predicate system	"From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate system."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample sizes (number of plates or screws tested). It refers to "performance testing" and "torque testing" but doesn't quantify the number of units tested.
Data Provenance: The data is generated from non-clinical (bench) testing performed by Wright Medical Technology, Inc. The country of origin for the data is not explicitly stated but is implied to be internal testing by the
US-based manufacturer. The testing is prospective for the purpose of this submission, designed to demonstrate substantial equivalence of the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This device is a bone plate system demonstrating substantial equivalence primarily through mechanical engineering tests and computational analysis (FEA), not through a diagnostic algorithm interpreting images or clinical data where human expert ground truth would be established.
Therefore, the concept of "experts establishing ground truth for the test set" (as would be applicable for an AI device) is not relevant in this context. The "ground truth" here is derived from established engineering principles and measurements.

4. Adjudication Method for the Test Set:

This question is not applicable as the study described is a non-clinical, mechanical performance study, not a study involving human readers or expert consensus on clinical findings.

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 MRMC comparative effectiveness study was done.
This is a mechanical implant device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No standalone algorithm performance study was done.
This is a mechanical implant device, not an algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on mechanical performance metrics and engineering standards. This includes:
- Quantifiable measurements of screw locking strength (e.g., torque values).
- Analysis of bending properties of plates.
- Comparison against established performance of the predicate device.
- Compliance with ASTM F136 or ISO 5832-3 standards for titanium alloy.
- Results from mechanically validated Finite Element Analysis (FEA).

8. The Sample Size for the Training Set:

This question is not applicable. This is a mechanical device, not an AI or machine learning model that requires a "training set." The design and validation relied on engineering principles, materials science, and mechanical testing.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as #8. There is no training set in the context of this device's validation.

Summary

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K120359 (pg 1/2)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY - 3 2012

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 ORTHOLOC™ 3Di Hallux System.

(a)(1). Submitted By:	Wright Medical Technology, Inc.5677 Airline RoadArlington, TN 38002
Date:	February 2, 2012
Contact Person:	Leslie FitchRegulatory Affairs Specialist(901) 867-4120
(a)(2). Proprietary Name:	ORTHOLOC™ 3Di Hallux System
Common Name:	Bone Plate System
Classification Name and Reference:	21 CFR 888.3030 - Class II
Device Product Code, Device Panel:	HRS: Orthopedic
(a)(3). Predicate Device:	K061808 - DARCO Locking Bone PlateSystem

(a)(4). Device Description

Wright Medical's ORTHOLOC™ 3Di Hallux System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and The subject plates are modified from the DARCO Locking Bone Plate System toes. (K061808). The system contains 33 plates belonging to 1 of 4 plate styles with various sizes and options, each contoured for specific anatomy and designed for specific procedures. All plates feature polyaxial locking screw holes and k-wire holes, and some plates have nonlocking compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm locking and non-locking screws.

(a)(5). Intended Use

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 .

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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 .

The indications statement has been tailored to the intended use of the subject device, which has fewer plates than the predicate system. The bones of the hand, wrist, ankles, and fingers included in the predicate indications statement are omitted from the indications for this system, because this system includes only plates designed for hallux procedures. The indications statement has also been modified to include specific procedures for which the system is designed. The addition of these specific examples of osteotomies and arthrodeses does not alter the intended therapeutic effect of the subject device. These specific procedures have been evaluated for safety and effectiveness through a clinical literature review.

(a)(6). Technological Characteristics Comparison

While many of the technological characteristics are the same for the subject device system and the predicate, some design changes have been made. The subject plates have a new polyaxial locking feature that offers locking up to 15° off-axis. The subject's locking feature is similar to the locking feature for ORTHOLOC"™ 3Di Ankle Plating System (K102429), but has been modified for the thinner plates of this system. The subject BOW and 18 Metatarsal plates are made from titanium alloy (TigAlaV), while the corresponding predicate plates are commercially pure titanium. The titanium alloy is a stronger material.

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

Performance testing supports the effectiveness of the new locking feature and the new screw and shows that no new worst-case plates (in bending) are introduced in this system. The subject plate locking mechanism evaluated in this testing was found to be acceptable for offaxis mechanical screw locking up to three times as compared to a non-locking screw. Torque testing was performed on the subject 2.7 mm non-locking screw and results exceeded the minimum safety factor. Through mechanically validated FEA analysis, the worst-case subject ORTHOLOC™ 3Di plates were found not to represent a new worst-case in bending for any of the four plate families evaluated.

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

N/A

(b)(3). Substantial Equivalence - Conclusions

The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. Performance testing supports the effectiveness of the new locking feature and the new screw and shows that no new worst-case plates (in bending) are introduced in this system. From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate system.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAY - 3 2012

Wright Medical Technology, Inc. % Ms. Leslie Fitch 5677 Airline Rd. Arlington, TN 38002

Received: February 6, 2012

Re: K120359

Trade/Device Name: ORTHOLOC™ 3Di Hallux 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: February 2, 2012

Dear Ms. Fitch:

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 I lease be advisou has i br mination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I cacial statutes and equirements, including, but not limited to: registration and listing (21 Comply with an the Fee oreagence of the Part 801); medical device reporting of medical

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Page 2 - Ms. Leslie Fitch

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overal) (2) 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 n you http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Tou may of Small Manufacturers, International and Consumer Assistance 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,

Ase Lm^m

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

Enclosure

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K120359 (pg. 1/1)

Indications for Use Statement

510(k) Number (if known): Not yet assigned.

Device Name: ORTHOLOC™ 3Di Hallux System

Indications for Use:

First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy O
- Closing base wedge osteotomy 0
- Crescentic osteotomy O
- Proximal Chevron osteotomy o
- Distal Chevron osteotomy (Austin) 0
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 O
- Revision of failed first MTP Arthroplasty implant O

X Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asb

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K120359

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.