TAMINA 3.5mm Proximal Humerus System
The TAMINA, TAMINA Long and TAMINA-TF Proximal Humerus System is indicated for
· Dislocated two-, three-, and four fragment fractures of the proximal humerus including osteopenic bone

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

POYA 3.5mm Lateral Proximal Tibia System
The POYA 3.5mm Lateral Proximal Tibia System is 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
· fractures with associated shaft fractures

LORRAINE 3.5mm Distal Humerus System
The LORRAINE 3.5mm Distal Humerus System is indicated for intra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

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 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, which includes TAMINA 3.5mm Proximal Humerus System, POYA 3.5MM Lateral Proximal Tibia System, and LORRAINE 3.5mm Distal Humerus System. The submission aims to establish substantial equivalence to previously cleared predicate devices.

However, the document does not describe a study involving an algorithm or artificial intelligence (AI). Instead, it focuses on the non-clinical testing performed to demonstrate the substantial equivalence of the Bonebridge Osteosynthesis Plating System (a medical device for bone fixation) to established predicate devices. The acceptance criteria and "device performance" described relate to the physical and material properties of the bone plates and screws, rather than the performance of a diagnostic or assistive AI system.

Therefore, many of the requested points, which are relevant to AI/algorithm studies (such as sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, and training set details), are not applicable to this document.

Here's the information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Sterilization	Validation using VDmax25 method as described in ISO 11137-2 for gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10^-6. Cleaning and sterilization procedures validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 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 in accordance with ISO 11607 1/2 and ASTM F1980. Transport simulation conducted according to ISTA 2A followed by: • Dye-Penetration, ASTM F1929 • Visual inspection, ASTM F1886/1886M • Seal strength, ASTM F88/F88M • Microbial barrier testing, DIN 58953-6, Chapter 2.14	Validation of the sterile packaging has been successfully performed in accordance with ISO 11607 1/2 and ASTM F1980. Transport simulation conducted according to ISTA 2A, followed by successful packaging verification tests (Dye-Penetration, Visual inspection, Seal strength, Microbial barrier testing).
Biocompatibility	Biological Evaluation and toxicological risk assessment to evaluate device's biological safety for the intended use, in accordance with ISO 10993-series.	Tests performed (Chemical Characterization, Cytotoxicity, and LAL Testing) successfully demonstrated biological safety.
Mechanical Testing	Non-inferiority of the Bonebridge device compared to the predicate device with regard to maximum force (static test) and maximum force for a given number of cycles (dynamic test). The predefined acceptance criteria were successfully met.	Static and dynamic comparative testing has been performed and included statistical analysis and comparative testing to the predicate devices. Non-inferiority of the Bonebridge device compared to the predicate device with regard to maximum force (static test) and maximum force for a given number of cycles (dynamic test). The predefined acceptance criteria were successfully met. Design verification was successfully completed and included compatibility of implants and instruments as well as assessment of anatomical shape and appearance.
MRI Safety	Assessment of displacement force and torque effects (ASTM F2052-21, ASTM F2213-17), heating effects (ASTM F2182-19 at 1.5T and 3T), and image artifacts (ASTM F2119-07 (2013)) to claim MR Conditional for local SAR.	Displacement force and torque effects assessed, heating effects assessed during MR scans at 1.5T and 3T, and image artifacts assessed at 3T. The tested implant and associated product family can be claimed as MR conditional considering local SAR.
Summative Usability	No significant usability issues are observed due to the study acceptance criteria of the primary objectives prior to Application/Usability Risk Assessment update.	Summative usability evaluation according to IEC 62366-1 shows that the Bonebridge Osteosynthesis Plating System has no significant usability issues. The study participants were able to use the products safely and effectively.

Regarding the AI/Algorithm specific questions:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document is not about an AI/algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is not about an AI/algorithm.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document is not about an AI/algorithm.
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 document is not about an AI/algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This document is not about an AI/algorithm.
The sample size for the training set: Not applicable. This document is not about an AI/algorithm.
How the ground truth for the training set was established: Not applicable. This document is not about an AI/algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 19, 2023

Bonebridge AG % Dawn Balazs-Metz Senior Consultant Meditec Consulting GmbH Obermoosstrasse 23 Berne, BE 3067 Switzerland

Re: K231292

Trade/Device Name: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus 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, HWC Dated: May 3, 2023 Received: May 4, 2023

Dear Dawn Balazs-Metz:

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) K231292

Device Name

TAMINA 3.5mm Proximal Humerus System; POYA 3.5mm Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System

Indications for Use (Describe)

TAMINA 3.5mm Proximal Humerus System

The TAMINA, TAMINA Long and TAMINA-TF Proximal Humerus System is indicated for

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

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

POYA 3.5mm Lateral Proximal Tibia System

The POYA 3.5mm Lateral Proximal Tibia System is 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
· fractures with associated shaft fractures

LORRAINE 3.5mm Distal Humerus System

The LORRAINE 3.5mm Distal Humerus System is indicated for intra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

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 K231292

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

ADMINISTRATIVE INFORMATION

Date prepared	July 07, 2023
Submission type:	Traditional 510(k)
Purpose of 510(k):	Modification of currently cleared device K213864Line extension of the cleared K213864 TAMINA 3.5mmProximal Humerus System and POYA 3.5mm Lateral ProximalTibia System and introduction of an additional plating systemLORRAINE 3.5mm Distal Humerus SystemA proposed modification to harmonize contraindications of thecleared (K213864) TAMINA 3.5mm Proximal Humerus Systemand POYA 3.5mm Lateral Proximal Tibia SystemAnnouncement of minor modifications to the device since thelast clearance (K213864)
Submitter	Bonebridge AGBahnhofstrasse 116300 ZugSwitzerland
Official Contact	Michelle GumpelmayerHead of QM & RA, Bonebridge AG
Alternative Contact	Dawn Balazs-MetzSenior consultant, meditec Consulting GmbHPhone: +41 79 772 5540Email balazs-metz@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:	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 System

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	DALVAZZA 2.5mm Distal Ulna SystemLEPORELLO 3.5mm Olecranon SystemLORRAINE 3.5mm Distal Humerus System
Common name:	Plate, Fixation, BoneScrew, Fixation, Bone
Regulation number:	21 CFR 888.3030 (primary),21 CFR 888.3040
Classification name:	Single/multiple component metallic bone fixationappliances and accessories (primary),Smooth or threaded metallic bone fixation fastener
Regulatory class:	Class II
Product Code:	HRS (primary), HWC
PREDICATE DEVICES
Primary predicate device:	Bonebridge Osteosynthesis Plating System (K213864)TAMINA 3.5mm Proximal Humerus System

Additional predicate devices:

TAMINA 3.5mm Proximal Humerus System	K041860 Synthes (USA) LCP® ProximalHumerus Plates, Long
	K011815 Synthes LCP Proximal HumerusPlates
	K082807 Synthes (USA) 3.5mm and 4.5mmLocking Compression Plate (LCP) System withExpanded Indications
POYA 3.5mm Lateral Proximal TibiaSystem (POYA-L)	K120689 SYNTHES 3.5 mm Variable Angle LCPProximal Tibia Plate system
	K082807 Synthes (USA) 3.5mm and 4.5mmLocking Compression Plate (LCP) System withExpanded Indications
LORRAINE 3.5mm Distal Humerus System	K120070 Synthes Variable Angle LCP ElbowSystem / Distal Humerus Plates
	K101056 VariAx Elbow System / Distal HumerusPlates
	K082807 Synthes (USA) 3.5mm and 4.5mmLocking Compression Plate (LCP) System withExpanded Indications

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INDICATIONS FOR USE

TAMINA 3.5mm Proximal Humerus System

The TAMINA, TAMINA Long 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

POYA 3.5mm Lateral Proximal Tibia System

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
. fractures with associated shaft fractures

LORRAINE 3.5mm Distal Humerus System

The LORRAINE 3.5mm Distal Humerus System is indicated for intra-articular or extraarticular fractures of the distal humerus, supracondylar fractures, osteotomies, and nonunions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

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, 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 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 NON-CLINICAL TESTS

Sterilization validation:	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.	Pass
Packaging validation:	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	Pass
Biocompatibility:	Biological Evaluation and toxicological risk assessment to evaluate device's biological safety for the intended use, in accordance with ISO 10993-series.Tests performed:Chemical Characterization, Cytotoxicity and LAL Testing	Pass
Mechanical testing:	Plates: Static and dynamic comparative testing has been performed and included statistical analysis and comparative testing to the predicate devices. Non-inferiority of the Bonebridge device compared to the predicate device with regard to maximum force (static test) and maximum force for a given number of cycles	Pass

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(dynamic test). The predefined acceptance criteria were successfully met.

Design verification was successfully completed and included compatibility of implants and instruments as well as assessment of anatomical shape and appearance

MRI safety: The Bonebridge Osteosynthesis Plating System is MR Pass 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 F2052-21 and ASTM F2213-17)
Assessment of heating effects due to the RF-field . during MR scans at 1.5Tesla and 3Tesla according to ASTM F2182-19
. Assessment of image artifacts at 3Tesla according to ASTM F2119-07 (2013)

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 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.