The Bonebridge POYA 3.5mm Posteromedial Tibia System is intended for adult patients and indicated for internal fixation of posteromedial proximal tibia fractures, including buttressing of fractures of the proximal and metaphyseal areas of the tibia. Additionally, the longer plates are indicated for fractures extending to the tibial shaft.

The POYA 3.5mm Medial Proximal Tibia System is intended for adult patients and indicated to buttress metaphyseal fractures of the medial tibia plateau, split- type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia.

The SALTI 2.5/3.5mm Ankle System is intended for fixation of the ankle in adult patients and particularly in osteopenic bone. Specifically,

the Medial and 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.
. The Posterior Distal Tibia Plate is intended to buttress partial articular fractures and bone fragments of the distal tibia.
. The 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 Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture.

Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone, All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Bonebridge Osteosynthesis Plating System." This type of document is centered on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through novel clinical studies in the way one might expect for a new, innovative diagnostic or AI device.

Therefore, the information typically requested in your prompt regarding acceptance criteria and performance against those criteria (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in this document.

The document primarily focuses on non-clinical tests to show that the new device is as safe and effective as its predicates. Here's a breakdown of the available information in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The document states that "All predefined acceptance criteria were successfully met" for mechanical testing, but it does not explicitly list these acceptance criteria or the specific numerical performance values for each. It only reports a "Pass" for each category of non-clinical testing.

Test Category	Acceptance Criteria (Explicitly stated in document?)	Reported Device Performance
Sterilization validation	Minimal dose of 25kGy (for gamma irradiation)	Pass
	SAL of 10^-6 (for gamma irradiation)	Pass
	132°C (270F) for 4 minutes and 20 min drying time (for steam sterilization)	Pass
Packaging validation	N/A (referenced standards ISO 11607 1/2, ASTM F1980, ISTA 2A, ASTM F1929, ASTM F1886/1886M, ASTM F88/F88M, DIN 58953-6 Chapter 2.14)	Pass
Biocompatibility	N/A (referenced standards ISO 10993-series and FDA guidance)	Pass
Mechanical testing	Substantially equivalent to predicate devices for maximum force (static) and maximum force for a given number of cycles (dynamic).	Pass
MRI safety	"MR conditional" considering local SAR	Pass
	Assessment of displacement force and torque effects (ASTM F2052-21, ASTM F2213-17)	Pass
	Assessment of heating effects (ASTM F2182-19)	Pass
	Assessment of image artifacts (ASTM F2119-07 (2013))	Pass
Usability tests	No significant usability issues (based on primary objectives prior Application/ Usability Risk Assessment update)	Successful

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document describes mechanical testing and refers to "design verification" which would involve testing prototypes, but does not detail the sample sizes for these tests, nor does it refer to patient data for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable/not provided. The "ground truth" concept is highly relevant for diagnostic devices or AI, where human experts (e.g., radiologists, pathologists) determine the correct diagnosis or outcome. For a bone plating system, performance is primarily assessed through biomechanical testing and material properties, not through expert-labeled patient data.

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

This information is not applicable/not provided for the reasons stated above. Adjudication relates to resolving disagreements among experts when establishing ground truth.

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:

This is not applicable/not provided. MRMC studies are typically for evaluating the impact of AI or diagnostic tools on human reader performance, which doesn't apply to a bone plating system.

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

This is not applicable/not provided. This device is a physical bone plating system, not an algorithm.

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

As discussed, the concept of "ground truth" in the diagnostic/AI sense is not applicable here. The "truth" for this device's performance is derived from standardized engineering and material testing (e.g., mechanical load tests, biocompatibility assessments, sterilization efficacy).

8. The sample size for the training set:

This information is not applicable/not provided. There is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.

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

This information is not applicable/not provided.

In summary: The document is a 510(k) submission for a bone plating system and focuses on demonstrating substantial equivalence through non-clinical testing. It does not contain information related to acceptance criteria or studies in the context of diagnostic or AI device performance as described in your prompt. The "acceptance criteria" where mentioned implicitly refer to passing engineering specifications and regulatory standards.

Summary

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October 31, 2024

Michelle Gumpelmayer Head of QM&RA Bahnhofstrasse 11 Zug, Zug 6300 Switzerland

Re: K242399

Trade/Device Name: Bonebridge Osteosynthesis Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: August 13, 2024 Received: August 13, 2024

Dear Michelle Gumpelmayer:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, MS Assistant Director, Biomedical Engineer DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242399

Device Name

Bonebridge Osteosynthesis Plating System

Indications for Use (Describe)

POYA 3.5mm Posteromedial Tibia System

POYA 3.5mm Medial Proximal Tibia System

SALTI 2.5/3.5mm Ankle System

The SALTI 2.5/3.5mm Ankle System is intended for fixation of the ankle in adult patients and particularly in osteopenic bone. Specifically,

· The Medial and 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.

· The Posterior Distal Tibia Plate is intended to buttress partial articular fractures and bone fragments of the distal tibia.

· The 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.

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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510(k) Summary

In accordance with 21 CFR 807.92 the following information is provided for the Bonebridge Osteosynthesis Plating System.

ADMINISTRATIVE INFORMATION

Date prepared	October 21, 2024
Submission type:	Traditional 510(k)
Purpose of 510(k):	Modification of currently cleared device K231292Line extension of the cleared K231292 POYA 3.5mmPosteromedial Tibia System and introduction of two additionalplating systems: the SALTI 2.5/3.5mm Ankle System and thePOYA 3.5mm Medial Proximal Tibia System.
Announcement of minor modifications to the device since thelast clearance (K231292)
Submitter	Bonebridge AGBahnhofstrasse 116300 ZugSwitzerland
Official Contact	Michelle GumpelmayerHead of QM&RA, Bonebridge AGPhone: +41 76 731 07 32Email michelle.gumpelmayer@bonebridge.ch
Alternative Contact	Alexander HäuslerCOO, Bonebridge AGPhone: +41 79 660 81 42Email alexander.haeusler@bonebridge.ch
US agent	Richard Robel, confinis corporationEmail: usagent@confinis.com

DEVICE NAME AND CLASSIFICATION

Trade name:	Bonebridge Osteosynthesis Plating System
Variants, types:	TRIFT 3.5mm 1/3 Tubular SystemSALGINA 2.5mm Volar Distal Radius SystemCASCELLA 3.5mm Superior Clavicle SystemTAMINA 3.5mm Proximal Humerus SystemPOYA 3.5mm Lateral Proximal Tibia SystemPOYA 3.5mm Posteromedial Tibia SystemDALVAZZA 2.5mm Distal Ulna SystemLEPORELLO 3.5mm Olecranon SystemLORRAINE 3.5mm Distal Humerus System

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		SITTER 3.5mm Versatile SystemPOYA 3.5mm Medial Proximal Tibia SystemSALTI 2.5/3.5mm Ankle System
Common name:	Plate, Fixation, Bone
Regulation number:	21 CFR 888.3030
Classification name:Single/multiple component metallic bone fixationappliances and accessories
Regulatory class:	Class II
Product Code:	HRS
PREDICATE DEVICESPrimary predicate device:		Bonebridge Osteosynthesis Plating System (K240318)SITTER 3.5mm Versatile System
Additional predicate devices:
POYA 3.5mm Posteromedial Tibia System		K082624 Synthes (USA) 3.5mm LCPPosteromedial Proximal Tibia Plates

K082807 Synthes (USA) 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications

K032269 Synthes (USA) 3.5 LCP Medial

POYA 3.5mm Medial Proximal Tibia System

SALTI 2.5/3.5mm Ankle System

K120854 Synthes Variable Angle LCP Ankle Trauma System

Proximal Tibia Plates

K082807 Synthes (USA) 3.5mm Locking Compression Plate (LCP) System with Expanded Indications

K011335 Synthes One-Third Tubular DCL Plate

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INDICATIONS FOR USE

POYA 3.5mm Posteromedial Tibia System

POYA 3.5mm Medial Proximal Tibia System

SALTI 2.5mm/3.5mm Ankle System

The SALTI 2.5/3.5mm Ankle System is intended for fixation of the ankle in adult patients and particularly in osteopenic bone. Specifically.

the Medial and 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.
. The Posterior Distal Tibia Plate is intended to buttress partial articular fractures and bone fragments of the distal tibia.
. The 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

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE

The subject device and the predicate devices have the same intended use, similar indications for 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, including plate screw holes to accommodate locking and nonlocking screws. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate

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devices. The subject and predicate devices are sterilized by the standard methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

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SUMMARY OF NON-CLINICAL TESTS

Sterilizationvalidation:	Gamma irradiation: The minimal dose of 25kGy is validatedusing VDmax25 method as described in ISO 11137-2 andconfirmed a Sterility Assurance Level SAL of 10-6.Steam sterilization: Cleaning and sterilization procedureshave been successfully validated in accordance with ISO17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and20 min drying time.	Pass
Packagingvalidation:	Validation of the sterile packaging has been successfullyperformed in accordance with ISO 11607 1/2 and ASTMF1980. Furthermore, a transport simulation was conductedaccording ISTA 2A followed by these packaging verificationtests:• Dye-Penetration, ASTM F1929• Visual inspection, ASTM F1886/1886M• Seal strength, ASTM F88/F88M• Microbial barrier testing, DIN 58953-6, Chapter 2.14	Pass
Biocompatibility:	Biological Evaluation and toxicological risk assessment toevaluate the device's biological safety for the intended use,in accordance with ISO 10993-series and FDA guidance.	Pass
Mechanicaltesting:	Static and dynamic comparative testing was performed foreach subject plate variant, including statistical analysis andcomparison to the respective predicate devices. Substantialequivalence of each Bonebridge subject plate variant to thecorresponding predicate devices (K231292, K120854,K082807, K011335, K082624, and K032269) wasdemonstrated with respect to maximum force (static test)and maximum force for a given number of cycles (dynamictest). All predefined acceptance criteria were successfullymet, demonstrating that the mechanical performance of eachsubject plate variant is substantially equivalent to thecorresponding predicate devices.Design verification was successfully completed for eachsubject plate variant, including compatibility verification ofimplants and instruments as well as assessment ofanatomical shape and appearance.	Pass
MRI safety:	The Bonebridge Osteosynthesis Plating System is MRconditional considering local SAR based on the followingtests• Assessment of displacement force and torque effects inthe main static magnetic field at 3Tesla. Additionally,the expected magnetic force in a stronger magneticfield gradient of 30T/m was extrapolated. (According toASTM F2052-21 and ASTM F2213-17)• Assessment of heating effects due to the RF-fieldduring MR scans at 1.5Tesla and 3Tesla according toASTM F2182-19• Assessment of image artifacts at 3Tesla according toASTM F2119-07 (2013)	Pass
SUMMARY OF NON-CLINICAL TESTS

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The tested implant and associated product family can be claimed as MR conditional.

SUMMARY OF CLINICAL AND USABILITY TESTS

Based on a clinical evaluation including literature review and the results of verification and validation activities it has been concluded that clinical investigations were not required. The summative usability evaluation according to IEC 62366-1 shows that the Bonebridge Osteosynthesis Plating System there are no significant usability issues due to the study acceptance criteria of the primary objectives prior Application/ Usability Risk Assessment update. Therefore, the summative usability evaluation studies of the Bonebridge Osteosynthesis Plating System are considered successful. The study participants were able to use the products safely and effectively.

CONCLUSION

The subject Bonebridge Osteosynthesis Plating System has similar indications, intended use, target populations, technological characteristics, and materials as the predicate devices. Non-clinical testing demonstrated that the performance of the proposed devices is substantially equivalent to the predicate devices.

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.