Wright's ORTHOLOC™ 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

Lateral Malleolar Fractures .
Syndesmosis injuries
Medial Malleolar Fractures
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Posterior Malleolar Fractures .
Distal Anterior Tibia Fractures
Vertical Shear Fractures of the Medial Malleolous
Pilon Fractures
Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
Lateral Malleolar Avusion Fractures

The ORTHOLOC™ 3Di locking screws are intended for use with Wright's ORTHOLOC™ 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Device Description

The ORTHOLOC™ 3Di Locking Screws subject to this premarket notification include the 2.7mm diameter-26, 28, and 30mm length locking screws. The ORTHOLOC™ Bone Screws subject to this premarket notification include the non-locking 2.7mm low profile bone screws. All screws are manufactured from titanium alloy and have a solid core. The implants are single use only devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for ORTHOLOC™ 3Di Locking Screws and ORTHOLOC™ Bone Screws. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove safety and effectiveness. Therefore, the information requested about acceptance criteria and a study proving device performance in the context of clinical outcomes or diagnostic accuracy is not applicable here.

The document explicitly states: "N/A-clinical evidence not required" in section B.2. Substantial Equivalence - Clinical Evidence. This means no clinical study with human subjects was performed or required to establish the device's performance against specific acceptance criteria.

Instead, the submission focused on non-clinical evidence to demonstrate substantial equivalence.

Here's how the provided information relates to your request:

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

Not Applicable. No explicit clinical acceptance criteria or reported device performance from clinical studies are mentioned. The "performance" is demonstrated through non-clinical testing and comparison to the predicate device.

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

Not Applicable. No human-based test set or data provenance is mentioned as no clinical studies were performed. The "test set" in this context would refer to physical device samples tested in a lab.

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. No ground truth establishment by medical experts is mentioned, as no clinical studies were conducted for this 510(k) submission.

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

Not Applicable. No clinical test set or adjudication method 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

Not Applicable. No MRMC study was done, and the device is a medical screw system, not an AI diagnostic tool.

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

Not Applicable. This pertains to an algorithm, not a physical medical device like a screw.

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

Not Applicable. For this submission, the "ground truth" for demonstrating equivalence relied on established engineering and materials standards, worst-case analyses, and physical testing of the device properties (ultimate, insertion, and removal torque).

8. The sample size for the training set

Not Applicable. No training set is mentioned as no machine learning algorithm is involved.

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

Not Applicable. No training set or ground truth establishment for it is mentioned.

In summary, the K120802 submission demonstrates substantial equivalence primarily through non-clinical evidence, specifically:

Comparison of design characteristics: The subject 2.7mm locking screws are identical to the predicate 2.7mm locking screws except for screw length. The subject 2.7mm bone/non-locking screws have an identical low-profile head and neck as the predicate 3.5 mm low-profile non-locking bone screws and identical thread form as the predicate 2.7mm locking screw.
Materials information: Both the subject and predicate devices are manufactured from titanium alloy.
Worst-case analyses: Performed to ensure the subject devices perform at least as well as the predicate devices under various conditions.
Ultimate, insertion, and removal torque testing: These mechanical tests were conducted to demonstrate that the subject screws perform at least as well as the legally marketed predicate screws in terms of mechanical properties.

The "acceptance criteria" in this context are inferred to be that the subject device's performance in these non-clinical tests (e.g., torque values) must be comparable to or better than that of the predicate device, thereby supporting its substantial equivalence and safety/effectiveness for the stated indications.

Summary

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K 120802 (113) APR - 2 2012

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 URTHOLOC™ 3Di Locking Screws and ORTHOLOCTM Bone Screws.

A.1. Submitted By:

Date:

Contact Person:

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

March 15, 2012

Sarah Holtgrewe Regulatory Affairs Project Specialist (901) 867-4476

A.2. Proprietary Name:

Common Name:

Device Classification Regulation:

Device Product Code & Panel:

A.3. Predicate Devices:

ORTHOLOC™ 3Di Locking Screws & ORTHOLOCTM Bone Screws

Locking Plate Screw & Bone Screw

21 CFR 888.3040-Class II

HWC: Screw, Fixation Bone HRS: Plate, Fixation, Bone 87 Orthopedics

K102429—ORTHOLOC™ 3Di Ankle Plating and ORTHOLOCTM System Bone Screws K112772—ORTHOLOC™ Bone Screws --Modification

A.4. Device Description

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K120802(2/3)

Image /page/1/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that appears to be a stylized letter "W". The graphic is composed of two thick, horizontal lines that converge towards the center, creating a sense of depth and movement. The overall design is clean and modern, with a focus on simplicity and visual impact.

A.5. Intended Use

Ankle Plates:

Wright's ORTHOLOC™ Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

Lateral Malleolar Fractures .
Syndesmosis injuries
Medial Malleolar Fractures
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Posterior Malleolar Fractures .
Distal Anterior Tibia Fractures
Vertical Shear Fractures of the Medial Malleolous
Pilon Fractures
Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
Lateral Malleolar Avusion Fractures

ORTHOLOC™ 3D iLocking Screws:

The ORTHOLOC™ 3Di locking screws are intended for use with Wright's ORTHOLOCTM 3Di Plating Systems of the same base material.

ORTHOLOCTM Bone Screws:

ORTHOLOC™ Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Washer

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

A.6. Technological Characteristics Comparison

The subject 2.7mm locking screws are identical to the predicate 2.7mm locking screws with the exception of screw length. The subject 2.7mm bone/non-locking screws have an identical low-profile head and neck as the predicate 3.5 mm low-profile non-locking bone screws and identical thread form as the predicate 2.7mm locking screw.

B.1. Substantial Equivalence - Non-Clinical Evidence

Substantial equivalence is shown through comparison of design characteristics, materials information, worst-case analyses, and ultimate, insertion, and removal torque testing. The

headquarters Wright Medical Technology, Inc

Arlington, TN 38002

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results show that the subject screws can be expected to perform at least as well as the legally marketed predicate screws.

B.2. Substantial Equivalence - Clinical Evidence

N/A-clinical evidence not required

B.3. Substantial Equivalence - Conclusions

Substantial equivalence is shown through design characteristics, materials information, worst-case analysis, and ultimate, insertion, and removal torque testing, The subject locking screws are identical in indication for use, and all dimensional characteristics except screw length. The subject bone screws have an identical low-profile head and neck as the predicate 3.5 mm low-profile non-locking bone screws and identical thread form as the predicate 2.7mm locking screws. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.

www.wmt.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Wright Medical Technology, Incorporated % Ms. Sarah Holtgrewe Regulatory Affairs Project Specialist 5677 Airline Road Arlington, Tennessee 38002

APR - 2 2012

Re: K120802

Trade/Device Name: ORTHOLOC™ 3Di Locking Screws & ORTHOLOC™ Bone Screws Regulation Number: 21 CFR 888.3040

Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS, HWC

Dated: March 15, 2012

Received: March 16, 2012

Dear Ms. Holtgrewe:

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 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.

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Page 2 – Ms. Sarah Holtgrewe

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/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 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

for Peter

Dan Cur

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

510(k) Number (if known): K120802

Device Name: ORTHOLOC™ 3Di Locking Screws & ORTHOLOC™ Bone Screws

Indications For Use:

Wright's ORTHOLOC™ 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

Lateral Malleolar Fractures .
Syndesmosis injuries
Medial Malleolar Fractures
Bi-Malleolar Fractures
Tri-Malleolar Fractures
Posterior Malleolar Fractures
Distal Anterior Tibia Fractures
Vertical Shear Fractures of the Medial Malleolous
Pilon Fractures
Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
Lateral Malleolar Avusion Fractures

The ORTHOLOC™ 3Di locking screws are intended for use with Wright's ORTHOLOC™ 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

D. Ovens

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

510(k) Number K120802

1 of 1

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.