Small and Large Fragments Osteosynthesis System NEOFIX is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, carpals, metacarpals, distal femur, proximal tibia, tibial pilon, fibula, calcaneus, tarsals and metatarsals; small fragments of the hand and wrist; pelvis and acetabulum fractures; periprosthetic fractures; metatarsal and phalangeal osteotomies; and carpal, metacarpal, wrist and ankle arthrodesis. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

Device Description

NEOFIX consists of plates and screws in a variety of designs and sizes and made from commercially pure titanium or Ti-6Al-4V alloy. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in cortical (locking and non-locking) and cancellous thread designs in various diameters and lengths.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Small and Large Fragments Osteosynthesis System NEOFIX". This type of submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent performance validation against pre-defined acceptance criteria in a clinical study. Therefore, most of the requested information about acceptance criteria, study design, and ground truth establishment is not applicable in this context.

Here's a breakdown of the available information:

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

Acceptance Criteria: Not explicitly stated as performance metrics in a clinical study. The acceptance criteria for a 510(k) submission are primarily to demonstrate substantial equivalence to predicate devices. This is achieved through comparisons of intended use, technological characteristics, materials, design, packaging, and sterilization methods.
Reported Device Performance:
- Demonstrated through engineering analysis and mechanical testing.
- Standards referenced: ASTM F382 (Standard Specification for Osteosynthesis Plates) and ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
- Conclusion from testing: "Any differences in the technological characteristics do not raise new issues of safety or efficacy."
- Overall similarities to predicates: Same intended use, operating principle, basic design, similar materials, similar packaging and sterilization.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (as demonstrated by the submission)
Equivalent Intended Use	The subject device has the same intended use as predicate devices.
Equivalent Operating Principle	The subject device uses the same operating principle as predicate devices.
Equivalent Basic Design	The subject device incorporates the same basic design as predicate devices.
Similar Materials	The subject device incorporates the same or very similar materials (commercially pure titanium or Ti-6Al-4V alloy) as predicate devices.
Similar Physical Dimensions	The subject device encompasses the same range of physical dimensions as predicate devices.
Similar Packaging and Sterilization	The subject device has similar packaging and is sterilized using the same materials and processes as predicate devices.
No New Issues of Safety or Efficacy	Engineering analysis and mechanical testing according to ASTM F382 and ASTM F543 demonstrated that any differences in technological characteristics do not raise new safety or efficacy issues.

2. Sample size used for the test set and the data provenance:

Not applicable. This was not a clinical study involving a test set of patient data. Performance was evaluated through mechanical testing of the device components.

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

Not applicable. There was no ground truth derived from expert consensus on patient data.

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

Not applicable. There was no adjudication of clinical outcomes or expert readings.

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 an orthopedic implant (plates and screws), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. The "ground truth" equivalent for this type of submission is adherence to established engineering standards (ASTM F382, ASTM F543) and demonstrable equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

Not applicable. As above, no training set was used.

Summary

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510(k) Summary K113733

MAR 2 3 2012

510(k) Summary

NEOORTHO Produtos Ortopédicos S/A

Small and Large Fragments Osteosynthesis System NEOFIX

K113733

February 22, 2012

ADMINISTRATIVE INFORMATION -

Manufacturer Name:

NEOORTHO Produtos Ortopédicos S/A Rua Ângelo Domingos Durigan 607, Cascatinha 82020-340 Curitiba - PR, Brazil +55 41 3535-1033 Telephone: Fax: +55 41 3535-1018

Official Contact:

Representative/Consultant:

Luciane Yumi Suzuki de Oliveira NEOORTHO Produtos Ortopédicos S/A

Kevin A. Thomas, PhD Linda K. Schulz, BSDH, RDH PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 USA Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 kthomas@paxmed.com Email: lschulz@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Small and Large Fragments Osteosynthesis System NEOFIX
Common Names:	Plate, fixation, boneScrew, fixation, bone
Classification Names:	Single/multiple component metallic bone fixation appliances andaccessoriesSmooth or threaded metallic bone fixation fastener
Classification Regulations:	21 CFR 888.3030, Class II	21 CFR 888.3040, Class II
Product Codes:	HRS	HWC
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Orthopedic Devices Branch

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INTENDED USE

Small and Large Fragments Osteosynthesis System NEOFIX is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, carpais, metacarpals, distal femur, proximal tibia, tibial pilon, fibula, calcaneus, tarsals and metatarsals; small fragments of the hand and wrist; pelvis and acetabulum fractures; periprosthetic fractures; metatarsal and phalangeal osteotomies; and carpal, metacarpal, wrist and ankle arthrodesis. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

NEOORTHO Produtos Ortopédicos S/A demonstrated that, for the purposes of FDA 's regulation of medical devices. Small and Large Fragments Osteosynthesis System NEOFIX is substantially equivalent in indications and design principles to the following predicate devices.

PredicateNumber	K Number	Company Name	Device Name
1	K012655	Acumed, Inc.	Congruent Bone Plate System
2	K071715	Acumed, Inc	Acumed Congruent Bone Plate System
3	K041860	Synthes (USA)	Synthes (USA) LCP® Proximal Humerus Plates, long
4	K011815	Synthes (USA)	Synthes LCP Proximal Humerus Plates
5	K101421	DePuy Orthopaedics, Inc	DePuy Anatomic Locked Plating System Long Plate Line Extension
6	K000684	Synthes (USA)	Synthes (USA) Small Fragment Dynamic Compression Locking (DCL)System
7	K011335	Synthes (USA)	Synthes One-Third Tubular Plate
8	K000558	Synthes (USA)	Synthes (USA) Wrist Fusion Plates (WFP)
9	K020401	Synthes (USA),	Synthes Calcaneal Plate
10	K020602	Synthes (USA)	Synthes Pilon Plate
11	K023802	Synthes (USA)	Synthes (USA) 4.5 mm Titanium LCP Proximal Tibia Plating System
12	K092609	Synthes (USA)	Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad LockingCompression Plates (LCP)
13	K010766	Synthes (USA)	Synthes (USA) Large Fragment Locking Compression Plate (LCP)System-T Plate
14	K081353	Synthes (USA)	Synthes (USA) TomoFix™ Medial Distal Femur Plates

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PredicateNumber	K Number	Company Name	Device Name
15	K023941	Synthes (USA)	Synthes (USA) TomoFix™ Osteotomy System
16	K000089	Synthes (USA)	Synthes 4.0 and 5.0 mm Locking Screws
17	K041533	Synthes (USA)	Peri-Prosthetic Screws
18	K033995	Synthes (USA)	Synthes (USA) 3.5 mm LCP Distal Humerus System
19	K043185	Synthes (USA)	Synthes (USA) 3.5 mm Cortex Screws
20	K961413	Synthes (USA)	Synthes Anatomical Locking Plate System
21	K061621	Synthes (USA)	Synthes (USA) 6.5 mm Cancellous Screws
22	K031573	Synthes (USA)	Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics. The subject and predicate devices encompass the same range of physical dimensions, are packaged using the same materials, and are to be sterilized by the same methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

Performance data provided to demonstrate substantial equivalence included engineering analysis and mechanical testing according to ASTM F382 and ASTM F543.

Overall, Small and Large Fragments Osteosynthesis System NEOFIX has the following similarities to the predicate devices:

has the same intended use, .
. uses the same operating principle,
incorporates the same basic design, .
incorporates the same or very similar materials, and ●
has similar packaging and is sterilized using the same materials and processes. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

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

NEOOTHO Produtos Orthopédicos S/A % PaxMed International, LLC Kevin A. Thomas, Ph.D. 11234 El Camino Real, Suite 200 San Diego, California 92130

MAR 2 3 2012

Re: K113733

Trade/Device Name: Internal Fixation System NEOFIX Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 9, 2012

Received: March 12, 2012

Dear Dr. Thomas:

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

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Page 2 - Kevin A. Thomas, Ph.D.

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/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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510(k) Summary K113733

Small and Large Fragments Osteosynthesis System NEOFIX

Indications for Use

K113733 510(k) Number:

Device Name:

Internal Fixation System NEOFIX

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

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111

Duyal

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

510(k) Number K113733

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.