The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,

Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Device Description

The Synthes Anterolateral Distal Tibia Plates are intended to treat fractures of the distal tibia. These plates can be used with a new screw configuration, 3.5mm VA Locking Screws. The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will be offered in both stainless steel and titanium alloy (TAN), and in both sterile and non-sterile configurations. The Anterolateral Distal Tibia Plates will be offered in left and right configurations. The system accepts existing cortical screws, locking screws, dynamic locking screws, and metaphyseal screws (K100776, K063049, K112583, K000684, K111230, K120070, K110592, and K043185) as well as new 3.5mm VA Locking Screws, and allows for both dynamic compression and locking through Combi holes.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, specifically the Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System - Anterolateral Distal Tibia Plates.

This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical safety and efficacy data. Therefore, the information you're requesting regarding acceptance criteria, study details, expert review, and ground truth establishment, which are typical for studies validating AI/ML diagnostic devices, are not present in this document. This submission focuses on engineering analysis and comparison to existing, already approved devices.

Here's why your specific questions cannot be answered from this document:

This is not an AI/ML device. The device is a physical bone fixation system (plates and screws). Therefore, concepts like "device performance" in terms of classification metrics (sensitivity, specificity), "test sets," "training sets," "ground truth" (in the context of expert consensus or pathology for diagnostic accuracy), or "MRMC studies" are not applicable.
510(k) is about substantial equivalence. The primary way this device met its acceptance criteria was by demonstrating that it is "at least as strong as" and has similar indications, design, materials, and performance characteristics as previously cleared predicate devices.

However, I can extract information related to the device and its "proof" of meeting requirements based on the document provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance / Evidence
Similar Indications for Use: Intended for fixation of the ankle in adults and adolescents (12-21) where growth plates have fused, particularly in osteopenic bone, for various distal tibia and fibula fractures.	The subject device (Synthes 2.7/3.5mm VA-LCP Ankle Trauma System) has similar indications to the predicate Synthes 2.7/3.5 VA-LCP Ankle Trauma System (K120854), Synthes 4.5/3.5 LCP Metaphyseal Plate (K033805), and Zimmer Periarticular and ECT Plate Systems (various K numbers).
Similar Design Characteristics: Refers to the physical shape, features, and configurations of the plates and screws.	Both the subject and predicate devices have similar design characteristics. The Anterolateral Distal Tibia Plates are offered in left and right configurations, and the system accepts existing cortical, locking, dynamic locking, and metaphyseal screws, as well as new 3.5mm VA Locking Screws, allowing for dynamic compression and locking through Combi holes.
Similar Materials: Stainless steel and titanium alloy (TAN) for the plates and screws.	Both the subject and predicate devices use similar materials (stainless steel and titanium alloy (TAN)).
Similar Performance Characteristics (Mechanical Strength): The device (plates and screws) must be at least as strong as predicate devices to ensure mechanical integrity for bone fixation.	The subject system (plates) has been shown to be at least as strong as the predicate devices through engineering analysis and fatigue strength testing. The new 3.5mm VA Locking Screws have been shown to be substantially equivalent to existing screws through analysis and dimensional comparison to predicate screws (3.5mm Cortex Screws K112583 and 3.5mm Locking Screws K000684).

Regarding the other points, as explained, they are not applicable or not provided in this 510(k) submission for a physical implantable device:

Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through engineering analysis and fatigue testing, not a "test set" of clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established by experts for a diagnostic assessment.
Adjudication method for the test set: Not applicable.
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 is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" equivalent here would be established engineering standards for strength and fatigue, against which the device was tested.
The sample size for the training set: Not applicable. No "training set" for an algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relied on demonstrating substantial equivalence through a comparison of indications, design, materials, and engineering performance (mechanical strength) to already approved predicate devices. It did not involve clinical studies or expert evaluations of diagnostic accuracy as would be the case for AI/ML diagnostic software.

Summary

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KIZI 601

6 2012 JUL

510(k) Summary

Date Prepared: June 22, 2012

Sponsor:	SynthesAngela F. Lassandro1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6854
Device Name:	Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System - AnterolateralDistal Tibia Plates
Classification:	Classification: Class II, §888.3030, Single/multiple component metallic bonefixation appliances and accessories.Product Code: HRS, HWC
Predicate Device:	Synthes 2.7/3.5 VA-LCP Ankle Trauma System (K120854)Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805)Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227,K043560, K030121, K051098, and Pre-amendment)3.5mm Cortex Screws (K112583)3.5 mm Locking Screws (K000684)Synthes 2.7mm VA Locking Screws (K100776)4.5mm VA Curved Condylar Plate Set (K110354)
DeviceDescription:	The Synthes Anterolateral Distal Tibia Plates are intended to treat fractures ofthe distal tibia. These plates can be used with a new screw configuration,3.5mm VA Locking Screws.The Anterolateral Distal Tibia Plates and 3.5mm VA Locking Screws will beoffered in both stainless steel and titanium alloy (TAN), and in both sterile andnon-sterile configurations. The Anterolateral Distal Tibia Plates will be offeredin left and right configurations.The system accepts existing cortical screws, locking screws, dynamic lockingscrews, and metaphyseal screws (K100776, K063049, K112583, K000684,K111230, K120070, K110592, and K043185) as well as new 3.5mm VALocking Screws, and allows for both dynamic compression and locking throughCombi holes.
Intended Use/Indications for Use	The Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System is intendedfor fixation of the ankle and is indicated in adults and adolescents (12-21) inwhich the growth plates have fused, and particularly in osteopenic bone.Specifically,• Anterolateral Distal Tibia Plates are intended for fixation ofosteotomies, fractures, nonunions, malunions, and replantations ofbones and bone fragments of the diaphyseal and metaphyseal regionsof the distal tibia.• Medial and Anteromedial Distal Tibia Plates are intended for fixationof osteotomies, fractures, nonunions, malunions, and replantations ofbones and bone fragments of the diaphyseal and metaphyseal regionsof the distal tibia,• Distal Tibia T Plates and Distal Tibia L Plates are intended to buttresspartial articular fractures and bone fragments of the distal tibia, and• Lateral Distal Fibula Plates are intended for fixation of osteotomies,fractures, nonunions, malunions, and replantations of bones and bonefragments of the diaphyseal and metaphyseal regions of the distalfibula.
SubstantialEquivalence:	Both the subject Synthes 2.7/3.5mm VA-LCP Ankle Trauma System andpredicate Synthes 2.7/3.5 VA-LCP Ankle Trauma System (K120854), Synthes4.5/3.5 LCP Metaphyseal Plate (K033805) and Zimmer Periarticular and ECTPlate (K040593, K042598, K043227, K043560, K030121, K051098, and Pre-amendment) Systems have similar indications, design characteristics, materials,and performance characteristics. The subject system has been shown to be atleast as strong as the predicate devices through engineering analysis and fatiguestrength testing. Similarly, the new screws have been shown to be substantiallyequivalent to existing screws through analysis and dimensional comparison tothe predicate 3.5mm Cortex Screws (K112583) and 3.5mm Locking Screws(K000684).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope.

Public Health Service

JUL

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

6 2012

Synthes % Ms. Angela F. Lassandro Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K121601

Trade/Device Name: Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System -Anterolateral Distal Tibia Plates

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: May 30, 2012 Received: June 1, 2012

Dear Ms. Lassandro:

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

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Page 2 - Ms. Angela F. Lassandro

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.

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 vours.

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): ______________________________________________________________________________________________________________________________________________________________________________

Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System Device Name:

Indications for Use:

· Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
· Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
· Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
· Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.

Prescription Use _ X (Per 21 CFR 801.109)

AND/OR

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

(PLEASE DÓ NOT WRITE BÈLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ast

(Division Sign-Off) Division o: urgical, Orthopedic, and Restorative Devices

K121601 510(k) Number_

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.