The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, osteotomies, and arthrodesis. appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement, or bone void filler.

The Field Orthopaedics BTES Plate Range and Plate Screws are in the fixation of fractures, osteotomies, and arthrodesis of the hand and other small bones. The system may be used in both adults and pediatric patients.

Device Description

The Field Orthopaedics Bony Trauma Extremity System (BTES) is an extremity trauma system consisting of a range of screws and a range of plates cleared in K200043.

The BTES screw range consists of a range of screws intended for standalone use, and a range of screws intended to be used with the BTES plate range. The standalone screw range consists of 1.2 mm solid, partially threaded screws of various lengths; 1.5 – 5.0 mm cannulated, partially threaded screws in both headless and headed designs of various lengths; and 2.0 - 3.0 mm Cannulated, fenestrated, partially threaded screws in both headless and headed designs of various lengths. The range of screws intended to be used with the BTES plate range consists of 1.2, 1.5, and 2.0 mm solid, fully-threaded screws of various lengths.

The purpose of this Special 510(k) device modification is to notify FDA of the sterile NX Nail System, which is a line extension to the BTES Screw Range described above and cleared in K200043. NX Nail implants are made from the same titanium alloy using the same manufacturing processes as BTES implants, are non-compressive in design, and are available in lengths ranging from 12 to 90 mm and diameters ranging from 2.0 to 5.0 mm. NX Nail implants are offered nonsterile and sterile (gamma radiation). This Special 510(k) also includes added instruments for implanting NX Nail devices.

Materials: All BTES screws in the Screw Range are made with Titanium alloy ELI (as per ASTM F136). All plates are available as identical configurations in both Titanium alloy ELI (as per ASTM F136) and CP Titanium (ISO 5832-2). Instruments are made from medical grades stainless steel, anodized aluminum, and marked with epoxy resin.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Bony Trauma Extremity System (BTES) Screw Range, NX Nail System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive AI performance evaluations.

Therefore, many of the requested elements are not applicable or cannot be extracted directly from this document. The information provided primarily pertains to the physical characteristics of the device and its equivalence to a prior cleared device.

However, I can extract the following information about the performance data related to the device. The "acceptance criteria" here refers to the internal criteria Field Orthopaedics Pty Ltd (or BioVera, Inc., the submitter) established for their verification and validation activities, and the "reported device performance" indicates that these criteria were met.

1. Table of acceptance criteria and the reported device performance

Test/Analysis Performed	Acceptance Criteria (Implied)	Reported Device Performance
Bending Strength	No new worst-case scenario relative to cleared BTES (K200043)	Demonstrated no new worst case
Pull Out Force	No new worst-case scenario relative to cleared BTES (K200043)	Demonstrated no new worst case
Insertion Torque	Met predefined acceptance criteria	Measured and met acceptance criteria
Removal Torque	Met predefined acceptance criteria	Measured and met acceptance criteria
Maximum Torque	Met predefined acceptance criteria	Measured and met acceptance criteria
Cleaning Validation	Met predefined acceptance criteria	Met acceptance criteria
Packaging Validation	Met predefined acceptance criteria	Met acceptance criteria
Sterilization	Met predefined acceptance criteria	Met acceptance criteria
Surgeon User Evaluation	Demonstrated devices work as intended	Demonstrated the NX Nail devices to work as intended
Biocompatibility	Met predefined acceptance criteria (instruments and implants)	Met acceptance criteria
Packaging Requirements	Met predefined acceptance criteria	Met acceptance criteria
Distribution Requirements	Met predefined acceptance criteria	Met acceptance criteria

The following information cannot be found in the provided document:

Sample sizes used for the test set and the data provenance: The document does not specify sample sizes for any of the engineering analyses or user evaluations. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. For a physical device like this, "ground truth" would typically refer to physical and mechanical testing standards, and "experts" might be engineers or surgeons, but details are absent.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the type of data presented.
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: This is not an AI device, so an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the engineering tests would be established by industry standards (e.g., ASTM standards for material properties, bending strength tests). For the surgeon user evaluation, the "ground truth" would be the subjective assessment of functionality by the surgeons. However, explicit details on these standards or how the "ground truth" was formally established are not in this summary.
The sample size for the training set: Not applicable, as this is not a machine learning or AI device.
How the ground truth for the training set was established: Not applicable, as this is not a machine learning or AI device.

Summary

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February 16, 2023

Field Orthopaedics Pty Ltd Jillianne Mckenzie Vice President, Regulatory Affairs 30 Florence St Teneriffe, QLD 4005 Australia

Re: K230118

Trade/Device Name: Bony Trauma Extremity System (BTES) Screw Range Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 16, 2023 Received: January 17, 2023

Dear Jillianne Mckenzie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230118

Device Name Bony Trauma Extremity System (BTES) Screw Range

Indications for Use (Describe)

The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, and arthrodesis. appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement, or bone void filler.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K230118

Special 510(k) Summary - Field Orthopaedics Bony Trauma Extremity System Screw Range, NX Nail System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the Bony Trauma Extremity System (BTES) Screw Range, NX Nail System.

A. SUBMITTER'S INFORMATION

Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis, NDIP, Québec, J7W 3J6,CANADA
Contact Person:	Robert A. Poggie, PhD
Phone & Fax Number:	514-901-0796
Date of Submission:	January 16, 2023

B. DEVICE IDENTIFICATION & MANUFACTURER

Manufacturer Name:	Field Orthopaedics Pty Ltd
Manufacturer Address:	30 Florence Street, Teneriffe 4005 QLD AUSTRALIA
Registration Number:	3015131017
Contact Name:	Jillianne McKenzie
Title:	Vice President, Regulatory Affairs
Device Trade Names:	Bony Trauma Extremity System (BTES) Screw Range
Device Common Names:	Screw, Fixation, Bone
Classification Names:	Smooth or threaded metallic bone fixation fastener
Classification Codes:	HWC - Class II
Classification Panel:	Orthopedic
Regulation Numbers:	21 CFR sections 888.3040

PRIMARY PREDICATE DEVICE K200043

Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws and Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range

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DEVICE DESCRIPTION

The Field Orthopaedics Bony Trauma Extremity System (BTES) is an extremity trauma system consisting of a range of screws and a range of plates cleared in K200043.

INDICATIONS FOR USE

The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, osteotomies, and arthrodesis, appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement, or bone void filler.

The Field Orthopaedics BTES Plate Range and Plate Screws are intended for use in the fixation of fractures, osteotomies, and arthrodesis of the hand and other small bones. The system may be used in both adults and pediatric patients.

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TECHNOLOGICAL CHARACTERISTICS

The Bony Trauma Extremity System (BTES) Screw Range, NX Nail System line extension, is substantially equivalent to the primary predicate device, the Field Orthopaedics Bony Trauma Extremity System (BTES), because they are manufactured from the same materials using the same manufacturing processes, and possess the same indications and intended uses. The NX Nail System line extension is within the design scope, intended and indicated uses for the BTES, and the updated instruments are within the scope of the cleared indicated use. The table below compares the technological characteristics.

	Subject Device, BTES Screw Range, NXNail System, K230118	Primary Predicate Device, FO BTESScrew Range and Plate Range, K200043
Reg, product code	888.3040, HWC	888.3040, HWC; 888.3030, HRS
Indication For Use	The Field Orthopaedics BTES ScrewRange is intended for use in the fixation offractures, osteotomies, and arthrodesis,appropriate for the size of the device, inadults and in both, children (2-12 years)and adolescents (12- 21 years), in whichgrowth plates have fused or in whichgrowth plates will not be crossed by screwfixation. The FO Fenestrated Screws arenot for the delivery of bone graft, bonecement or bone void filler.The Field Orthopaedics BTES Plate Rangeand Plate Screws are intended for use inthe fixation of fractures, osteotomies, andarthrodesis of the hand and other smallbones. The system may be used in bothadults and pediatric patients.	The Field Orthopaedics BTES ScrewRange is intended for use in the fixation offractures, osteotomies, and arthrodesis,appropriate for the size of the device, inadults and in both, children (2-12 years)and adolescents (12- 21 years), in whichgrowth plates have fused or in whichgrowth plates will not be crossed by screwfixation. The FO Fenestrated Screws arenot for the delivery of bone graft, bonecement or bone void filler.The Field Orthopaedics BTES Plate Rangeand Plate Screws are intended for use inthe fixation of fractures, osteotomies, andarthrodesis of the hand and other smallbones. The system may be used in bothadults and pediatric patients.
Type	Non-Compressive Headless	Compression Head and Headless
Cannulated	Yes	Yes and No
Self-Drilling	Yes	Yes
Inner/Outer DiameterFor compression headand headless	NX Nail:	Fenestrated:2.0 to 3.0mm diam.6 to 60mm longMicro:1.2 to 2.0 mm diam.6 to 16 mm longNano:1.2 mm diam.6 to 20 mm long
LengthFor compression headand headless	2.0 to 5.0mm in diameter,12 to 90mm in length	Compression:1.2 to 5.0 mm6 to 90 mm long
Material	Titanium Alloy (F136)	Titanium Alloy (F136)
Sterile	Yes and No (NX Nail); No (Remainingcomponents of BTES Screw Range, NX NailSystem)	No (BTES in K200043)

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Comparison of the technological characteristics and indicated use of the subject and primary predicate devices demonstrate that the subject device, the BTES Screw Range, NX Nail System, is substantially equivalent to the primary predicate device.

PERFORMANCE DATA

Verification and validation (V&V) activities included the following:

· Engineering analyses of NX Nail implants for bending strength and pull out force relative to cleared BTES demonstrated no new worst case,
· Insertion, removal, and maximum torques of NX Nail implants were measured and met acceptance criteria,
· Cleaning, packaging, and sterilizations for the sterile NX Nail met acceptance criteria.
· Surgeon user evaluation demonstrated the NX Nail devices to work as intended, and
· Assessment of biocompatibility of instruments and implants, packaging, and distribution requirements for the subject devices met acceptance criteria.

CONCLUSION

The data presented in this Special 510(k) device modification show the BTES Screw Range, NX Nail System, is substantially equivalent to the legally marketed primary predicate device, the Field Orthopaedics Bony Trauma Extremity System (BTES). It has the same or similar technological characteristics, materials, sizes, manufacturing processes, and principles of operation as the primary predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.