Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System

Synthes ALPS System is a plate and screw system intended to treat fractures of various long bones including radius, ulna, humerus, tibia, fibula, and femur. The Synthes ALPS is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System

Synthes LCP System is intended for buttressing multifragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, ad non -unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.

The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and nonunions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma navigation system

The Synthes Curved Condylar Plates are intended for buttressing multi-fragmentary distal femur fractures, including: supracondylar, intra-articular and extra articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System

Synthes LCP Distal Femur Plates are intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.

Device Description

The Synthes (USA) Brainlab Compatible Instruments consist of manual insertion handles and aiming arms which are used to facilitate the surgical technique related to the Synthes Lateral Entry Femoral Nail, LISS, LCP Distal Femur Plate, Locking Condylar Plate, and Curved Condylar Plate systems. The instruments primarily facilitate the manual insertion of the bone plate and intramedullary nail implants included in the predicate systems, but also include a design feature which allows attachment of system accessories to the Brainlab Trauma navigation system.

AI/ML Overview

The provided document is a 510(k) summary for the "Synthes Brainlab Trauma Compatible Instruments". This submission is to modify existing cleared systems to introduce manual accessory instruments intended for compatibility with the Brainlab Trauma Navigation System.

The document does not contain acceptance criteria in the traditional sense of performance metrics (like accuracy, sensitivity, specificity) for a diagnostic or AI device. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The study performed is a simulated use study and dimensional tolerance analyses, not a clinical study to assess performance against specific acceptance criteria for an AI or diagnostic tool.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted or inferred from the provided text, while explicitly noting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the document. The submission is focused on demonstrating substantial equivalence, meaning the modified instruments perform as intended and do not raise new questions of safety or effectiveness compared to the predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly stated for performance metrics. The implicit "acceptance criterion" is to demonstrate substantial equivalence, meaning no adverse effects on safety and effectiveness.	"Dimensional tolerance analyses and simulated use studies were conducted and the results support the conclusion that there are no effects of the modification subject to this premarket notification on the safety and effectiveness of the predicate systems."

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

Sample Size for Test Set: Not applicable. This was a simulated use study and dimensional tolerance analysis, not a test set of medical cases. The number of instruments or surgical simulations is not specified.
Data Provenance: Not applicable. The study involved engineering analysis and simulated use, likely conducted in a lab environment. No information on country of origin for patient data or retrospective/prospective nature is relevant here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. Ground truth as typically defined for diagnostic or AI studies is not relevant here. The study involved engineering assessments and potentially surgical technique evaluations by product developers or surgical experts, but their number and specific qualifications for establishing 'ground truth' are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This type of study does not involve adjudication of expert readings or diagnoses.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is not an AI or diagnostic device designed to improve human reader performance. It's a surgical instrument modification.
Effect Size of AI vs. Without AI Assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done: Not applicable. This is a manual surgical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of diagnostic or AI performance. The "ground truth" for this submission would be defined by engineering standards, functional requirements for instrument compatibility and surgical technique, and safety assessments.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not involve machine learning or a training set.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable.

Summary

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510(k) Summary	Page 1 of 3
Purpose of Submission:	Is to modify the following previously cleared systems: Synthes(USA) Synthes Lateral Entry Femoral Nail (K040336) SynthesLISS System (Synthes Anatomic Locking Plate System)(K961413) Synthes (USA) Locking Condylar Plate System(K000066) Synthes (USA) LCP Curved Condylar Plates(K041911) Synthes LCP Distal Femur Plates (K062564) tointroduce modified instruments, which are manual accessoryinstruments intended to facilitate compatibility with the BrainlabTrauma Navigation System.
Sponsor:	Synthes (USA)
	1301 Goshen Parkway
	West Chester, PA 19380
	(610) 719-6604
Date:	July 30, 2011
Contact:	Christopher Hack, Esq.Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941
Device Name:	Synthes Brainlab Trauma Compatible Instruments
Classification:	Class II, §888.3020 - Intramedullary fixation rod.
	Product Code: HSB (Rod, Fixation, Intramedullary and Accessoies).
	Class II, §888.3030 - Single/multiple component metallic bonefixation appliances and accessories.
	Product Code: HRS (Plate, Fixation, Bone).
	Product Code: KTT (Appliance, Fixation, Nail/Blade Combination,Multiple Component).
PredicateDevices:	Synthes (USA) Synthes Lateral Entry Femoral Nail (K040336)
	Synthes LISS System (Synthes Anatomic Locking Plate System)(K961413)
	Synthes (USA) Locking Condylar Plate System (K000066)
	Synthes (USA) LCP Curved Condylar Plates (K041911)
	Synthes LCP Distal Femur Plates (K062564)
DeviceDescription:	The Synthes (USA) Brainlab Compatible Instruments consist ofmanual insertion handles and aiming arms which are used to facilitatethe surgical technique related to the Synthes Lateral Entry Femoral

CONFIDENTIAL

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Nail, LISS, LCP Distal Femur Plate, Locking Condylar Plate, and Curved Condylar Plate systems. The instruments primarily facilitate the manual insertion of the bone plate and intramedullary nail implants included in the predicate systems, but also include a design feature which allows attachment of system accessories to the Brainlab Trauma navigation system.

Intended Use:

Synthes LCP Distal Femur Plates are intended for buttressing multi-fragmentary distal femur fractures

CONFIDENTIAL

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KIII891

including: supracondylar, intra-articular and extraarticular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.

Substantial Equivalence:

Information presented in this premarket notification supports that there are no effects of the described modification on the safety and effectiveness of the predicate Synthes Lateral Entry Femoral Nail (K040336), Synthes Distal Femur LISS (Synthes Anatomic Locked Plating System, K961413), Synthes Locking Condylar Plate System (K000066), Synthes LCP Curved Condylar Plate System (K041911), and Synthes LCP Distal Femur Plates (K062564). The modification does not affect the predicate system's indications for use, design of intramedullary implants, fundamental technology and or implant material composition.

Dimensional tolerance analyses and simulated use studies were conducted and the results support the conclusion that there are no effects of the modification subject to this premarket notification on the safety and effectiveness of 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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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

Synthes (USA) % Mr. Christopher Hack, Esq. 1301 Goshen Parkway West Chester, PA 19380

NOV 2 8 2011

Re: K111891

Trade/Device Name: Synthes Brainlab Trauma Compatible Instruments Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HRS, KTT Dated: October 27, 2011 Received: October 31, 2011

Dear Mr. Hack:

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

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Page 2 - Mr. Christopher Hack, Esq.

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Einel Keith

S/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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510(k) Number (if known): K111891 (pg. 1 of 5)

Device Name: Synthes (USA) Lateral Entry Femoral Nail System

INDICATIONS FOR USE:

Prescription Use X (Per 21 CFR 801.109)

AND/OR

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Hayes to Mxm

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

510(k) Number

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510(k) Number (if known): K111891 (pg.2 of 5)

Device Name:

Synthes (USA) Anatomic Locking Plate System

INDICATIONS FOR USE:

Prescription Use X (Per 21 CFR 801.109) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Owens to MXM

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

510(k) Number K111891

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510(k) Number (if known): K111891 (pg. 3 of 5)

Device Name:

Synthes (USA) Locking Condylar Plates

INDICATIONS FOR USE:

Synthes LCP System is intended for buttressing multi-fragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and cxtractive unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Ques formym

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

510(k) Number K111891

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510(k) Number (if known): K111891 (pg. 4 of 5)

Device Name:

Synthes (USA) LCP Curved Plates

INDICATIONS FOR USE:

The Synthes Curved Broad Plates are intended for fixation of various long bone, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and non-unions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma navigation system

The Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intraarticular and extra articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System

Prescription Use X (Per 21 CFR 801.109)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------	--

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number Y 1118

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510(k) Number (if known): K111891 (pg, 5 of 5)

Device Name:

Synthes (USA) LCP Distal Femur Plate

INDICATIONS FOR USE:

Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intraarticular and extra-articular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System

Prescription Use X (Per 21 CFR 801.109) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Owens for MXM

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

510(k) Number K111891

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.