(60 days)
Not Found
No
The device description and performance studies focus on the mechanical properties, biocompatibility, and sterilization of bone plates and screws, with no mention of AI or ML.
Yes
The device is a plating system with plates and screws intended for the fixation of fractures, malunions, non-unions, and osteotomies of various bones (distal radius, clavicle, olecranon, and proximal ulna), which are therapeutic indications for restoring function and stability.
No
The device description and intended use clearly state that this is a system for treating fractures by providing fixation (osteosynthesis), not for diagnosing conditions.
No
The device description explicitly states it consists of plates, screws, and instruments made of various materials (stainless steel, titanium, PEEK, EPDM, silicone), which are physical 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 fixation of bone fractures and related conditions (malunions, non-unions, osteotomies). This is a surgical intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description details plates, screws, and instruments made of materials like stainless steel and titanium, designed for surgical implantation. This aligns with orthopedic implants, not diagnostic devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the Bonebridge Osteosynthesis Plating System is a surgical device used for treating bone fractures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SALGINA 2.5mm 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 LEPORELLO 3.5mm Olecranon System is indicated for - · fractures
- · osteotomies
- · nonunions
of the olecranon and proximal ulna.
Product codes
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
Distal Radius, clavicle shaft, lateral clavicle, olecranon, proximal ulna
Indicated Patient Age Range
Not Found
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: Non-clinical tests (Sterilization validation, Packaging validation, Biocompatibility, Mechanical testing, MRI safety).
Sample Size: Not specified for each test, but studies were performed using relevant standards.
Key Results: All tests passed. Substantial equivalence to predicate devices was demonstrated for mechanical performance. MR conditional status was confirmed.
Clinical studies were not required. Usability evaluation was successfully completed.
Key Metrics
Not Found
Predicate Device(s)
K240318, K142906, K191848, K082807, K102694, K073186, K000684, K120070
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2024
Bonebridge AG Michelle Gumpelmayer Head of QM&RA Bahnhofstrasse 11 Zug, Zug 6300 Switzerland
Re: K243308
Trade/Device Name: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) 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: October 21, 2024
Dear Michelle Gumpelmayer:
Received: October 21, 2024
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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thomas Mcnamara -S
For: 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
Indications for Use (Describe)
The SALGINA 2.5mm 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 LEPORELLO 3.5mm Olecranon System is indicated for
- · fractures
- · osteotomies
- · nonunions
of the olecranon and proximal ulna.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) Summary
In accordance with 21 CFR 807.92 the following information is provided for the Bonebridge Osteosynthesis Plating System.
ADMINISTRATIVE INFORMATION
| Date prepared | October 21, 2024 |
|---|---|
| Submission type: | Traditional 510(k) |
| Purpose of 510(k): | Modification of currently cleared device K240318: |
| Line extensions of the cleared SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System and LEPORELLO 3.5mm Olecranon System | |
| Announcement of minor modifications to the device since the last clearance (K240318) | |
| 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 |
| Trade name: | Bonebridge Osteosynthesis Plating System |
|---|---|
| Variants, types: | TRIFT 3.5mm 1/3 Tubular System |
| SALGINA 2.5mm 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 |
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| SITTER 3.5mm Versatile System | ||
|---|---|---|
| ------------------------------- | -- | -- |
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 (K240318) |
|---|---|
| SALGINA 2.5mm Distal Radius System |
Additional predicate devices:
| SALGINA 2.5mm Distal Radius System
(line extension) | K142906 APTUS Wrist 2.5 System
(volar plates) |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | K191848 APTUS Wrist 2.5 System
(wrist spanning plate) |
| | K082807 Synthes (USA) 3.5mm
Locking Compression Plate (LCP)
System with Expanded Indications |
| | K102694 2.4mm Variable Angle LCP
Dorsal Distal Radius System |
| CASCELLA 3.5mm Superior Clavicle
System (line extension) | K073186 Synthes 3.5mm LCP
Clavicle Plate System |
| | K000684 Synthes Small Fragment
Dynamic Compression Locking (DCL)
System |
| LEPORELLO 3.5mm Olecranon
System (line extension) | K120070 Synthes Variable Angle LCP
Elbow System / Olecranon Plates |
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INDICATIONS FOR USE
The SALGINA 2.5mm 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 LEPORELLO 3.5mm Olecranon System is indicated for
- · fractures
- osteotomies
- nonunions
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 (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 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.
7
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. | Pass |
| Mechanical
testing: | Static and dynamic comparative testing was performed for
each subject plate variant, including statistical analysis and
comparison to the respective predicate devices. Substantial
equivalence of each Bonebridge subject plate variant to the
corresponding predicate devices (K240318, K142906,
K191848, K082807, K102694, K120070, K073186, and
K000684) was demonstrated with respect to maximum force
(static test) and maximum force for a given number of cycles
(dynamic test). All predefined acceptance criteria were
successfully met, demonstrating that the mechanical
performance of each subject plate variant is substantially
equivalent to the corresponding predicate devices.
Design verification was successfully completed for each
subject plate variant, including compatibility verification 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 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 F3110-24 | Pass |
8
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 a literature review and the results of verification and validation activities, it was concluded that clinical investigations were not required. The results of the summative usability evaluation, conducted in accordance with IEC 62366-1, confirm that no significant usability issues were identified with the use of the Bonebridge Osteosynthesis Plating System. Following the line extensions and updates to the Usability Risk Assessment, the originally established acceptance criteria remain applicable. Therefore, the summative usability evaluation studies for the Bonebridge Osteosynthesis Plating System are considered successful.
CONCLUSION
The subject Bonebridge Osteosynthesis Plating System has similar indications, intended use, target populations, technological characteristics, and materials as the predicate devices. Non-clinical testing demonstrated that the performance of the proposed devices is substantially equivalent to the predicate devices.