The TAMINA® and TAMINA®TF Proximal Humerus System is indicated for:
· Dislocated two-, three-, and four fractures of the proximal humerus including fractures involving osteopenic bone.

· Pseudarthroses (non-unions) of the proximal humerus
· Osteotomies of the proximal humerus

The POYA® 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including:

simple fractures
· comminuted fractures
· lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures
· depression fractures
· periprosthetic fractures
· nonunions, malunions, tibial osteotomies and osteopenic bone

The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia.

The DALVAZZA® 2.5mm Distal Ulna System is indicated for

· fixation of fractures
nonunions
of the distal ulna.

The LEPORELLO® 3.5mm Olecranon System is indicated for

fractures
· osteotomies
non-unions
of the olecranon and proximal ulna.

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 (ISO 5832-1 or ASTM F138 or ASTM F899), 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 surqical use. Non-clinical testing has demonstrated the devices are MR Conditional.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Bonebridge Osteosynthesis Plating System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a clinical study with detailed acceptance criteria for diagnostic performance. Therefore, the information typically requested regarding acceptance criteria for diagnostic accuracy, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies is not directly applicable or available in this document.

However, the document does list various performance tests conducted to establish substantial equivalence. I will present the information related to device performance and the testing conducted, framed within the principles of acceptance criteria where possible.

Here's a breakdown of the requested information based on the provided text, acknowledging the limitations inherent in a 510(k) summary:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance like sensitivity or specificity, as it's not a diagnostic device. Instead, it describes various engineering and material tests. The acceptance criterion for these tests is generally that the device performs equivalently to or better than the predicate device, or meets relevant international standards.

Test Category	Acceptance Criteria (Implied from text)	Reported Device Performance
Sterilization Validation	Gamma irradiation: Achieve a Sterility Assurance Level (SAL) of 10^-6 as per ISO 11137-2 (VDmax25 method).Steam sterilization: Successfully validated according to ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes with 20 min drying time.	Gamma irradiation: The minimal dose of 25kGy is validated using VDmax25 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10-6.Steam sterilization: Cleaning and sterilization procedures have been successfully validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying time.
Packaging Validation	Successful validation according to ISO 11607 1/2 and ASTM F1980. Includes transport simulation (ISTA 2A) followed by specific packaging verification tests (Dye-Penetration, Visual Inspection, Seal Strength, Microbial Barrier Testing).	Validation of the sterile packaging has been successfully performed in accordance with ISO 11607 1/2 and ASTM F1980. Furthermore, a transport simulation was conducted according ISTA 2A followed by these packaging verification tests: Dye-Penetration, ASTM F1929; Visual inspection, ASTM F1886/1886M; Seal strength, ASTM F88/F88M; Microbial barrier testing, DIN 58953-6, Chapter 2.14.
Mechanical Testing	Plates: Predefined acceptance criteria for static and dynamic testing successfully met, including statistical analysis and comparative testing to predicate devices.Screws: Successfully tested in accordance with ASTM F543 and includes comparative testing to predicate devices.Design Verification: Compatibility of implants and instruments, and assessment of anatomical shape and appearance successfully completed.	Plates: Static and dynamic testing has been performed and included statistical analysis and comparative testing to the predicate devices. The predefined acceptance criteria were successfully met.Screws: Tested successfully in accordance with ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws and includes comparative testing to predicate devices.Design verification was successfully completed and included compatibility of implants and instruments as well as assessment of anatomical shape and appearance.
MRI Safety	MR conditional status based on tests for displacement force and torque, heating effects due to RF-field, and image artifacts. (Tests according to ASTM F2052-15, ASTM F2213-17, ASTM F2182-11a, ASTM F2119-07).	The Bonebridge Osteosythesis Plating System is MR conditional considering local SAR based on the following tests: Assessment of displacement force and torque effects in the main static magnetic field at 3Tesla. Additionally, the expected magnetic force in a stronger magnetic field gradient of 30T/m was extrapolated. (According to ASTM F2052-15 and ASTM F2213-17); Assessment of heating effects due to the RF-field during MR scans at 1.5Tesla and 3Tesla according to ASTM F2182-11a; Assessment of image artifacts at 3Tesla according to ASTM F2119-07 (2013).
Usability	No significant usability issues are identified, meeting predefined acceptance criteria from the study. Study participants must be able to use the products safely and effectively.	Summative usability evaluation studies in accordance with IEC 62366-1 support that 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 Osteosythesis Plating System are considered as successful. The study participants were able to use the products safely and effectively.
Biocompatibility	Assessment performed in accordance with ISO 10993-1.	A biological assessment has been performed in accordance with ISO 10993-1.
Clinical Evaluation	Not required if existing interventions for relevant indications match surgical technique, device design, and material, and if verification and validation activities are conclusive.	Based on the results of the literature review and the results of verification and validation activities it has been concluded that clinical investigations are not required, since surgical technique, device design and material match established interventions for the relevant indications.

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 given text. The document refers to "testing" performed (e.g., static and dynamic testing for plates, testing for screws, packaging validation, MRI safety tests), but it does not specify the sample sizes of devices or materials used for these engineering tests. There's no "test set" in the context of diagnostic data.

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/provided as this is an orthopedic implant (osteosynthesis plating system), not an AI/diagnostic device that would require expert-established ground truth for a test set. Usability studies were conducted with "study participants," but their qualifications or number for establishing ground truth are not detailed.

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

This information is not applicable/provided. As noted above, this device is not an AI/diagnostic device.

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 information is not applicable/provided. This is an orthopedic implant, not an AI-assisted diagnostic tool.

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

This information is not applicable/provided. This is an orthopedic implant, not an algorithm/AI.

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

This information is not applicable/provided in the context of diagnostic accuracy. For the engineering tests, the "ground truth" would be established by the specifications of the materials, the design requirements, and the standards (e.g., ISO, ASTM) against which the device was tested. For usability, the ground truth is the successful and safe operation by participants.

8. The sample size for the training set

This information is not applicable/provided. This device is an orthopedic implant and does not involve AI or a "training set" in the machine learning sense.

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

This information is not applicable/provided. As above, it is not an AI device.

Summary

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September 2, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Bonebridge AG % Sandra Soniec Managing Director meditec Consulting GmbH Obermoosstrasse 23 Boll, Berne 3067 Switzerland

Re: K213864

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 3, 2022 Received: August 4, 2022

Dear Sandra Soniec:

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.

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

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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 medical devices and radiation-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, M.P.H. Assistant Director 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

510(k) Number (if known) K213864

Device Name

Bonebridge Osteosynthesis Plating System

Indications for Use (Describe)

The SALGINA® 2.5mm Volar Distal Radius System is indicated for

· Intra-articular fractures of the Distal Radius
· Extra-articular fractures of the Distal Radius

The CASCELLA® 3.5mm Superior Clavicle System is indicated for:

fixation of fractures of the clavicle shaft
· fixation of fractures of the lateral clavicle
malunions of the clavicle
· non-unions of the clavicle

The TAMINA® and TAMINA®TF Proximal Humerus System is indicated for:

· Dislocated two-, three-, and four fractures of the proximal humerus including fractures involving osteopenic bone.

· Pseudarthroses (non-unions) of the proximal humerus
· Osteotomies of the proximal humerus

The POYA® 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including:

simple fractures
· comminuted fractures
· lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures
· depression fractures
· periprosthetic fractures
· nonunions, malunions, tibial osteotomies and osteopenic bone

The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia.

The DALVAZZA® 2.5mm Distal Ulna System is indicated for

· fixation of fractures
nonunions

of the distal ulna.

The LEPORELLO® 3.5mm Olecranon System is indicated for

fractures
· osteotomies
non-unions

of the olecranon and proximal ulna. Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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	December 03, 2021
Submission type:	Traditional 510(k)
Purpose of 510(k):	Modification of currently cleared device K203002Line Extension
Submitter	Bonebridge AGBahnhofstrasse 116300 ZugSwitzerland
Official Contact	Christof GerberCEO, Bonebridge AG
Alternative Contact	Sandra SoniecSenior consultant, meditec Consulting GmbHPhone: +41 31 535 3193Email soniec@meditec-consulting.ch
US agent	Viky Verna, confinis corporationEmail: viky.verna@confinis.com

DEVICE NAME AND CLASSIFICATION

Trade name:	Bonebridge Osteosynthesis Plating System
Variants, types:	SALGINA 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 System
Common name:	Plate, Fixation, Bone
Regulation number:	21 CFR 888.3030
Classification name:	Single/multiple component metallic bone fixationappliances and accessories

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Regulatory class:	Class II
Product Code:	HRS
PREDICATE DEVICES
Primary predicate device:	Bonebridge Osteosythesis Plating System (K203002)	TRIFT 3.5mm 1/3 Tubular System
Additional predicate devices:
SALGINA 2.5mm Volar Distal Radius System	Medartis APTUS 2.5 TriLock Distal Radius Fracture Plate
	K142906, K051567 APTUS® Wrist 2.5 System
CASCELLA 3.5mm Superior Clavicle System	SYNTHES LCP Superior Clavicle Plate 3.5mm
	K111540, K073186 Synthes 3.5mm LCP Clavicle Plate System
TAMINA 3.5mm Proximal Humerus System	SYNTHES PHILOS Proximal Humeral Plate 3.5mm
	K011815 Synthes LCP Proximal Humerous Plates (Standard)
POYA 3.5mm Lateral Proximal Tibia System (POYA-L)	SYNTHES 3.5 mm Variable Angle LCP Proxima Tibia Plate system
	K120689 SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
POYA 3.5mm Posteromedial Tibia System (POYA-P)	SYNTHES 3.5mm LCP Posteromedial Tibia Plate
	K082624 SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES
DALVAZZA 2.5mm Distal Ulna System	SYNTHES 2.0mm LCP Distal Ulna Plate
	K092247 SYNTHES LOCKING HAND PLATES
LEPORELLO 3.5mm Olecranon System	SYNTHES VA-LCP Olecranon Plate
	K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM

INDICATIONS FOR USE

The SALGINA® 2.5mm Volar Distal Radius System is indicated for

Intra-articular fractures of the Distal Radius
. Extra-articular fractures of the Distal Radius

The CASCELLA® 3.5mm Superior Clavicle System is indicated for:

fixation of fractures of the clavicle shaft •

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. fixation of fractures of the lateral clavicle
. malunions of the clavicle
. non-unions of the clavicle

The TAMINA® and TAMINA®TF Proximal Humerus System is indicated for:

. Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic bone.
Pseudarthroses (non-unions) of the proximal humerus
Osteotomies of the proximal humerus

The POYA® 3.5mm Lateral Proximal Tibia System is indicated for is indicated for is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including:

. simple fractures
comminuted fractures
. lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures
. depression fractures
. periprosthetic fractures
. nonunions, malunions, tibial osteotomies and osteopenic bone

The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia.

The DALVAZZA® 2.5mm Distal Ulna System is indicated for

. fixation of fractures
. nonunions

of the distal ulna.

The LEPORELLO® 3.5mm Olecranon System is indicated for

• fractures
. • osteotomies
. . non-unions

of the olecranon and proximal ulna.

DEVICE DESCRITION

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE

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, including plate screw holes to accommodate locking and non-locking screws. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate 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.

SUMMARY OF PERFORMANCE DATA

Sterilization validation:	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 procedures havebeen successfully validated in accordance with ISO 17664 andISO 17665-1 at 132°C (270F) for 4 minutes and 20 min dryingtime.
Packaging validation:	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
Mechanical testing:	Plates: Static and dynamic testing has been performed andincluded statistical analysis and comparative testing to thepredicate devices. The predefined acceptance criteria weresuccessfully met.
	Screws: Tested successfully in accordance with ASTM F543:Standard Specification and Test Methods for Metallic MedicalBone Screws an includes comparative testing to predicatedevices.Design verification was successfully completed and includedcompatibility of implants and instruments as well asassessment of anatomical shape and appearance.
MRI safety:	The Bonebridge Osteosythesis Plating System is MRconditional considering local SAR based on the following tests Assessment of displacement force and torque effects inthe main static magnetic field at 3Tesla. Additionally, theexpected magnetic force in a stronger magnetic fieldgradient of 30T/m was extrapolated. (According to ASTMF2052-15 and ASTM F2213-17) Assessment of heating effects due to the RF-field duringMR scans at 1.5Tesla and 3Tesla according to ASTMF2182-11a Assessment of image artifacts at 3Tesla according toASTM F2119-07 (2013)
Usability:	Summative usability evaluation studies in accordance with IEC62366-1 support that there are no significant usability issuesdue to the study acceptance criteria of the primary objectivesprior Application/ Usability Risk Assessment update.Therefore, the summative usability evaluation studies of theBonebridge Osteosythesis Plating System are considered assuccessful. The study participants were able to use theproducts safely and effectively.
Clinical evaluation:	Based on the results of the literature review and the results ofverification and validation activities it has been concluded thatclinical investigations are not required, since surgicaltechnique, device design and material match establishedinterventions for the relevant indications.

Biocompatibility: A biological assessment has been performed in accordance with ISO 10993-1.

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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 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.