The ORTHOLOC™ APS consists of straight and pre-contoured plates that accept nonlocking and locking screws of various lengths and diameters. All components are manufactured from titanium alloy and available sterile or non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ORTHOLOC™ Ankle Plating System (APS). This regulatory submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested sections (e.g., acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable as this type of submission does not typically involve such studies for mechanical devices like bone plating systems.

The clearance is based on demonstrating the device's design features, materials, and intended use are substantially equivalent to existing, legally marketed devices. The FDA letter confirms that the device is subject to general controls and, potentially, special controls for Class II devices.

Here's a breakdown of what can be extracted from the provided text:

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

Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission is demonstrational: Substantial Equivalence to legally marketed predicate devices. This is established through comparisons of design features, materials, and indications for use.

Reported Device Performance: The document does not report specific quantitative performance data for the ORTHOLOC™ APS in terms of clinical outcomes, mechanical strength, or other metrics often found in studies for diagnostic algorithms. Instead, the "performance" is implicitly deemed equivalent to the predicate devices due to similar design and materials.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate devices in:	Similar design features, materials (titanium alloy), and indications for use (fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula).
- Design features	"substantially equivalent to the design features of other devices previously cleared for market."
- Materials	"All components are manufactured from titanium alloy."
- Indications for use	"is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula."

2. Sample sized used for the test set and the data provenance

Not Applicable: This type of submission does not typically involve a "test set" in the context of clinical or diagnostic performance studies. Substantial equivalence is primarily proven through engineering analysis, material testing, and comparison with predicate devices, not human or patient data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No "ground truth" for a test set is established in this 510(k) submission. Regulatory review is performed by FDA personnel based on the provided documentation and existing regulations.

4. Adjudication method for the test set

Not Applicable: There is no test set or adjudication process described.

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: This device is a bone plating system, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not Applicable: This is a physical medical device, not an algorithm.

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

Not Applicable: No ground truth in this sense is used. The "ground truth" for substantial equivalence is the existence and established safety and effectiveness of the identified predicate devices.

8. The sample size for the training set

Not Applicable: There is no "training set" for this type of medical device submission.

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

Not Applicable: No training set or associated ground truth establishment is described.

Summary

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K091243 . 1/1

JUN 26 2009

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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC™ Ankle Plating System.

Submitted By:	Wright Medical Technology, Inc.
Date:	April 16, 2009
Contact Person:	Sarah Holtgrewe
	Sr. Regulatory Affairs Specialist
Proprietary Name:	ORTHOLOC™ APS
Common Name:	Bone Plate System
Device Classification Regulation:	21 CFR 888.3030--Class II
Device Product Code & Panel:	HRS: Plate, Fixation, Bone/ Orthopedic

DEVICE INFORMATION

A. INTENDED USE

The ORTHOLOCTM Ankle Plating System (APS) is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula.

B. DEVICE DESCRIPTION

The design features of the ORTHOLOC™ APS are substantially equivalent to the design features of other devices previously cleared for market.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the ORTHOLOC™ APS are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the ORTHOLOCTM APS is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technologies, Inc. % Ms. Sarah Holtgrewe 5677 Airline Road Arlington, TN 38002

Re: K091243

Trade/Device Name: ORTHOLOC Ankle Plating System (APS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: HRS, HWC Dated: April 27, 2009 Received: April 28, 2009

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.

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 (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.

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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/cdrb/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

sincerely, yours,

Barbara Buettner

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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K091243

Indications for Use

510(k) Number (if known):

Device Name: ORTHOLOC® APS

Indications For Use:

The ORTHOLOC® Ankle Plating System (APS) is intended for fixation of fractures osteotomies, and non-unions of the distal tibia and fibula.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aular Breen
Division S

Division Sign-Off Division of Surgical, Orthopedi and Restorative Devices

5.10(k) Number K091243

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.