(203 days)
Bonebridge Osteosynthesis Plating System (K231292)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of traditional orthopedic implants, with no mention of AI/ML technologies or related data analysis.
Yes
The device is described as "fixation of fractures, osteotomies and nonunions" of bones, which implies a direct medical intervention for healing or stabilizing a physical condition, falling under the definition of a therapeutic device.
No
The device is indicated for fixation of fractures, osteotomies, and nonunions, which is a treatment rather than a diagnostic function.
No
The device description explicitly details physical components made of stainless steel, titanium, PEEK, EPDM, and silicone, including plates, screws, and instruments. It also mentions sterilization and MR Conditional status, all indicative of a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, osteotomies and nonunions" of various bones. This is a surgical intervention for treating physical injuries.
- Device Description: The description details plates, screws, and instruments made of materials like stainless steel and titanium, designed for surgical implantation and fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula
Indicated Patient Age Range
adult patients
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)
- Sterilization validation: Gamma irradiation (minimal dose of 25kGy) and Steam sterilization (132°C (270F) for 4 minutes and 20 min drying time) were validated. Result: Pass
- Packaging validation: Validated according to ISO 11607 1/2 and ASTM F1980 with transport simulation (ISTA 2A) and packaging verification tests. Result: Pass
- Biocompatibility: Biological Evaluation and toxicological risk assessment performed per ISO 10993-series and FDA guidance. Tests performed: Chemical Characterization, Cytotoxicity and LAL Testing. Result: Pass
- Mechanical testing: Static and dynamic comparative testing performed with statistical analysis and comparative testing to the predicate device. Non-inferiority of the Bonebridge device compared to the predicate device was demonstrated with regard to maximum force (static test) and maximum force for a given number of cycles (dynamic test). Design verification was successfully completed. Result: Pass
- MRI safety: Assessed for displacement force and torque effects (ASTM F2052-21 and ASTM F2213-17), heating effects (ASTM F2182-19e1), and image artifacts (ASTM F2119-07 (2013)). The device is MR conditional. Result: Pass
- Clinical and Usability Tests: Based on a clinical evaluation (including literature review) and verification/validation activities, clinical investigations were not required. Summative usability evaluation according to IEC 62366-1 showed no significant usability issues. 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.
Bonebridge Osteosynthesis Plating System (K231292)
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
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August 23, 2024
Bonebridge AG Michelle Gumpelmayer Head of OM&RA Bahnhofstrasse 11 Zug, Zug 6300 Switzerland
Re: K240318
Trade/Device Name: SITTER 3.5mm Versatile 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: July 29, 2024 Received: July 30, 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/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.
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).
1
Your device is also subject to, among other requirements, the Quality System (QS) 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 820.30 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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/trainingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-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 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)
Device Name
SITTER 3.5mm Versatile System
Indications for Use (Describe)
The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.
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 | July 29, 2024 |
|---|---|
| Submission type: | Traditional 510(k) |
| Purpose of 510(k): | Modification of currently cleared device K231292 |
| Introduction of an additional plating system SITTER 3.5mm | |
| Versatile System | |
| Announcement of minor modifications to the device since the | |
| last clearance (K231292) | |
| Submitter | Bonebridge AG |
| Bahnhofstrasse 11 | |
| 6300 Zug | |
| Switzerland | |
| Official Contact | Michelle Gumpelmayer |
| Head of QM&RA, Bonebridge AG | |
| Phone: +41 76 731 07 32 | |
| Email michelle.gumpelmayer@bonebridge.ch | |
| Alternative Contact | Alexander Häusler |
| COO, Bonebridge AG | |
| Phone: +41 79 660 81 42 | |
| Email alexander.haeusler@bonebridge.ch | |
| US agent | Richard Robel, confinis corporation |
| Email: usagent@confinis.com | |
| DEVICE NAME AND CLASSIFICATION | |
| Trade name: | SITTER 3.5mm Versatile System |
| (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 | |
| DALVAZZA 2.5mm Distal Ulna System | |
| LEPORELLO 3.5mm Olecranon System | |
| LORRAINE 3.5mm Distal Humerus System | |
| SITTER 3.5mm Versatile System |
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| Common name: | Plate, Fixation, Bone |
|---|---|
| Regulation number: | 21 CFR 888.3030 |
| Classification name: | Single/multiple component metallic bone fixation |
| appliances and accessories | |
| Regulatory class: | Class II |
| Product Code: | HRS |
| PREDICATE DEVICES | |
| Primary predicate device: | Bonebridge Osteosynthesis Plating System (K231292) |
| TAMINA 3.5mm Proximal Humerus System | |
| Additional predicate devices: |
SITTER 3.5mm Versatile System
K082807 Synthes (USA) 3.5 mm Locking Compression Plate (LCP) System with Expanded Indications
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INDICATIONS FOR USE
SITTER 3.5mm Versatile System:
The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.
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.
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.
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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 the device's biological safety for the intended use,
in accordance with ISO 10993-series and FDA guidance.
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 device. 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. | Pass |
| MRI safety: | The Bonebridge Osteosynthesis Plating System is MR
conditional considering local SAR based on the following
tests Assessment of displacement force and torque
effects of the implant in the main static magnetic
field at 3.0Tesla according to ASTM F2052-21 and
ASTM F2213-17. Additionally, the expected
magnetic force in a stronger magnetic field gradient
of 30T/m was extrapolated. Assessment of heating effects due to the RF-field
during MR scans at 1.5Tesla and 3Tesla according
to ASTM F2182-19e1. Assessment of image artifacts at 3Tesla according
to ASTM F2119-07 (2013) The tested implant and associated product family can be | Pass |
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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.