The ORTHOLOC™ 3Di Midfoot/Flatfoot 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: Flatfoot Osteotomies - Lateral column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) - Medial Displacement Calcaneal Osteotomy (MDCO) 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

Device Description

Wright Medical's ORTHOLOC™ 3Di Midfoot/Flatfoot 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) or the CLAW II Polyaxial Compression System (K113014). The system contains 23 plates belonging to 1 of 8 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 some plates have non-locking compression slots and kwire holes. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm ORTHOLOC™ 3Di locking and ORTHOLOC™ non-locking screws.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the ORTHOLOC™ 3Di Midfoot/Flatfoot System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance:
- Not introduce new worst-case plates in bending compared to predicate devices.	- "Performance testing 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 Midfoot/Flatfoot plates were found not to represent a new worst-case in bending for any of the eight plate styles evaluated when compared to the most similar DARCO or CLAW II plates."
- Maintain mechanical equivalence to predicate devices.	- "A dimensional engineering analysis was also provided in order to help establish mechanical equivalence."
Safety and Effectiveness:
- New design characteristics do not raise new questions of safety or effectiveness.	- "The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness."
- Perform at least as well as the predicate devices.	- "From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate systems."
Intended Use:
- Indications for use are similar to or supported by predicate devices, without altering the intended therapeutic effect.	- "The indications statement is similar to the DARCO predicate system's indications for use statement and has been tailored to the intended use of the subject device..."- "The addition of these specific examples of osteotomies and arthrodeses does not alter the intended therapeutic effect of the subject device."- "Some of these procedures are part of a predicate indications statement, and the others are supported by technologically similar predicates designed and marketed for these procedures."
Material Composition:
- Plates made from biocompatible and established materials (Titanium alloy).	- "The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3..."- "The subject plates are made from titanium alloy (Ti6AlaV), while some of the corresponding predicate plates are commercially pure titanium or stainless steel." (Implies material is acceptable as it's a difference noted without a safety concern).
Functional Features:
- Polyaxial locking feature offers equivalent or improved functionality compared to existing predicate features where applicable.	- "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 of the predicate CLAW II and identical to the locking feature for ORTHOLOC™ 3Di Hallux (K120359)." (Implies functionality is acceptable due to similarity or identity to predicate/equivalent devices).

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

Test Set Sample Size: The document does not specify a distinct "test set" in the context of clinical data or human evaluation. The mechanical performance evaluation involved all eight plate styles within the system, comparing them to "the most similar DARCO or CLAW II plates."
Data Provenance: The mechanical performance data is based on non-clinical evidence, specifically "mechanically validated FEA analysis" and "dimensional engineering analysis." This implies the data is derived from engineering simulations and analyses, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective distinction in the typical clinical sense.

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

This information is not applicable as the provided document details a 510(k) submission primarily relying on non-clinical, engineering-based performance testing for substantial equivalence. There is no mention of "experts" establishing "ground truth" for a test set in the context of clinical outcomes or human diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Mechanical and dimensional engineering analyses do not typically involve adjudication by human experts in this manner.

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

An MRMC comparative effectiveness study was not done. This submission is for a medical device (bone plate system), not an AI diagnostic or assistive technology.

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

A standalone performance study of an algorithm was not done. This device is a physical bone plate system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance testing was based on established engineering principles and validated finite element analysis (FEA) models, compared against the known performance characteristics of the predicate devices. It also relied on dimensional engineering analysis to establish mechanical equivalence. Essentially, the "truth" was defined by established mechanical performance standards and direct comparison to predicate devices' known mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI algorithm described in this 510(k) submission. The mechanical analysis relies on the design parameters of the eight plate styles in the system and their comparison to predicate device designs.

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

This information is not applicable as there is no training set for an AI algorithm. The mechanical "ground truth" for comparing the new plates to predicates would be derived from the pre-existing design specifications, material properties, and established performance data of the predicate devices.

Summary

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K121651 1/3

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

OCT 1 2 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 URTHOLOCTM 3Di Midfoot/Flatfoot System.

(a)(1). Submitted By:

Date:

Contact Person:

(a)(2). Proprietary Name:

Common Name:

Classification Name and Reference:

Device Product Code, Device Panel:

(a)(3). Predicate Device:

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

June 1, 2012

Leslie Fitch Regulatory Affairs Specialist (901) 867-4120

ORTHOLOC™ 3Di Midfoot/Flatfoot System

Bone Plate System

21 CFR 888.3030 - Class II

HRS: Orthopedic

K061808 - DARCO Locking Bone Plate System

K113014 - CLAW II Polyaxial Compression System

K100618 - Orthohelix Variable Angle Plates

K 100502 - Ascension Plating System

K11663 - DePuy A.L.P.S. Total Foot System

(a)(4). Device Description

(a)(5). Intended Use

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K121651$\frac{2}{3}$

Flatfoot Osteotomies

· Lateral column Lengthening (Evans Osteotomy)
· Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
· Medial Displacement Calcaneal Osteotomy (MDCO)

Mid / Hindfoot Fusions

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

The indications statement is similar to the DARCO predicate system's indications for use statement and has been tailored to the intended use of the subject device, which has fewer plates than the DARCO system. The bones of the hand, wrist, ankles, and fingers, and toes included in the predicate indications statement are omitted from the indications for this system, because this system includes only plates designed for midfoot and flatfoot 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. Some of these procedures are part of a predicate indications statement, and the others are supported by technologically similar predicates designed and marketed for these procedures.

(a)(6). Technological Characteristics Comparison

While many of the technological characteristics are the same for the subject device system and the DARCO predicate system, 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 of the predicate CLAW II and identical to the locking feature for ORTHOLOC™ 3Di Hallux (K120359). The subject plates are made from titanium alloy (Ti6AlaV), while some of the corresponding predicate plates are commercially pure titanium or stainless steel.

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

Performance testing 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 Midfoot/Flatfoot plates were found not to represent a new worst-case in bending for any of the eight plate styles evaluated when compared to the most similar DARCO or CLAW II plates. A dimensional engineering analysis was also provided in order to help establish mechanical equivalence.

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

N/A

(b)(3). Substantial Equivalence - Conclusions

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The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. Performance testing 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 systems. . •

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

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

OCT 12 2012

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

. Re: K121651

Trade/Device Name: ORTHOLOC 3Di Midfoot/Flatfoot System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: September 19, 2012 Received: September 20, 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 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

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Page 2 - Ms. Leslie H. Fitch

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to 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 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/ReportalProblem/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Indications for Use Statement

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

Device Name: ORTHOLOC™ 3Di Midfoot/Flatfoot System

Indications for Use:

Flatfoot Osteotomies

Lateral column Lengthening (Evans Osteotomy) ●
Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton ● Osteotomy)
Medial Displacement Calcaneal Osteotomy (MDCO) ●

Mid / Hindfoot Fusions

LisFranc Arthrodesis and/or Stabilization .
15(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

Asundi

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

K121651

510(k) Number

Prescription Use __ X (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)

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.