(76 days)
Not Found
No
The summary describes a traditional osteosynthesis plating system for fracture fixation, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an "internal fixation for fractures," indicating its use in treating medical conditions directly by providing structural support to bones, which aligns with the definition of a therapeutic device.
No
This device is an osteosynthesis plating system, intended for the internal fixation of bone fractures. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of plates, screws, and instruments made of stainless steel and titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the internal fixation of bone fractures and related conditions (pseudarthroses, osteotomies) in specific anatomical locations (proximal humerus, proximal tibia, distal humerus). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a plating system consisting of plates, screws, and instruments made of materials like stainless steel and titanium. These are typical components of orthopedic implants used for surgical fixation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Focus on Mechanical and Structural Performance: The performance studies described focus on mechanical testing, sterilization, packaging, biocompatibility, and MRI safety – all relevant to a surgically implanted device for bone fixation. There are no studies related to diagnostic accuracy or performance.
In summary, the device is an orthopedic implant designed for the surgical treatment of bone fractures, which falls under the category of medical devices used for structural support and repair, not for in vitro diagnostic testing.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal humerus, proximal tibia, distal humerus
Indicated Patient Age Range
Adults and skeletally mature adolescents (for POYA 3.5mm Lateral Proximal Tibia System)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests:
Sterilization validation: Gamma irradiation and Steam sterilization. Pass.
Packaging validation: Validation of sterile packaging. Pass.
Biocompatibility: Biological Evaluation and toxicological risk assessment in accordance with ISO 10993-series. Pass.
Mechanical testing: Static and dynamic comparative testing of plates to predicate devices. Non-inferiority of the Bonebridge 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 successfully completed, including compatibility of implants and instruments and assessment of anatomical shape and appearance. Pass.
MRI safety: Assessment of displacement force and torque effects in the main static magnetic field at 3Tesla, heating effects due to the RF-field during MR scans at 1.5Tesla and 3Tesla, and image artifacts at 3Tesla. The tested implant and associated product family can be claimed as MR conditional.
Clinical and Usability Tests:
Clinical investigations were not required based on a clinical evaluation including literature review and the results of verification and validation activities. The summative usability evaluation according to IEC 62366-1 shows no significant usability issues based on study acceptance criteria; considered successful. Study participants were able to use the products safely and effectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K213864, K041860, K011815, K082807, K120689, K120070, K101056
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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 K213864 |
| Line extension of the cleared K213864 TAMINA 3.5mm | |
| Proximal Humerus System and POYA 3.5mm Lateral Proximal | |
| Tibia System and introduction of an additional plating system | |
| LORRAINE 3.5mm Distal Humerus System |
A proposed modification to harmonize contraindications of the
cleared (K213864) TAMINA 3.5mm Proximal Humerus System
and POYA 3.5mm Lateral Proximal Tibia System
Announcement of minor modifications to the device since the
last clearance (K213864) |
| Submitter | Bonebridge AG
Bahnhofstrasse 11
6300 Zug
Switzerland |
| Official Contact | Michelle Gumpelmayer
Head of QM & RA, Bonebridge AG |
| Alternative Contact | Dawn Balazs-Metz
Senior consultant, meditec Consulting GmbH
Phone: +41 79 772 5540
Email balazs-metz@meditec-consulting.ch |
| US agent | Viky Verna, confinis corporation
Email: viky.verna@confinis.com |
DEVICE NAME AND CLASSIFICATION
| Trade name: | Bonebridge Osteosynthesis Plating System |
|---|---|
| Variants, types: | TRIFT 3.5mm 1/3 Tubular System |
| SALGINA 2.5mm Volar Distal Radius System | |
| CASCELLA 3.5mm Superior Clavicle System | |
| TAMINA 3.5mm Proximal Humerus System | |
| POYA 3.5mm Lateral Proximal Tibia System | |
| POYA 3.5mm Posteromedial Tibia System |
4
| | DALVAZZA 2.5mm Distal Ulna System
LEPORELLO 3.5mm Olecranon System
LORRAINE 3.5mm Distal Humerus System |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| Regulation number: | 21 CFR 888.3030 (primary),
21 CFR 888.3040 |
| Classification name: | Single/multiple component metallic bone fixation
appliances 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® Proximal
Humerus Plates, Long |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | K011815 Synthes LCP Proximal Humerus
Plates |
| | K082807 Synthes (USA) 3.5mm and 4.5mm
Locking Compression Plate (LCP) System with
Expanded Indications |
| POYA 3.5mm Lateral Proximal Tibia
System (POYA-L) | K120689 SYNTHES 3.5 mm Variable Angle LCP
Proximal Tibia Plate system |
| | K082807 Synthes (USA) 3.5mm and 4.5mm
Locking Compression Plate (LCP) System with
Expanded Indications |
| LORRAINE 3.5mm Distal Humerus System | K120070 Synthes Variable Angle LCP Elbow
System / Distal Humerus Plates |
| | K101056 VariAx Elbow System / Distal Humerus
Plates |
| | K082807 Synthes (USA) 3.5mm and 4.5mm
Locking Compression Plate (LCP) System with
Expanded Indications |
5
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
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.
6
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 |
7
(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.