(213 days)
No
The device description and performance studies focus on the material properties and mechanical performance of the bone screws, with no mention of AI or ML technology.
Yes.
The device is indicated for "maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, arthrodesis, and bone grafts," which are medical conditions that require treatment for healing and alignment.
No
Explanation: The device is a surgical implant designed for the fixation of bone fractures and grafts. It aims to maintain alignment and fix bone; it does not diagnose medical conditions.
No
The device description clearly states it is a physical bone screw made of degradable material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The OSSIOfiber™ Compression Screws are physical implants designed to be surgically placed within the body to fix bone fractures and provide structural support.
- Intended Use: The intended use clearly states the device is for "maintenance of alignment and fixation of bone fractures... of the upper extremity, fibula, knee, ankle and foot". This is a therapeutic and structural function, not a diagnostic one performed on a specimen outside the body.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
OSSIOfiber™ Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.
Product codes
HWC
Device Description
The OSSIOfiber™ Compression Screws are cannulated bone screws made of degradable poly (Llactide-co-D. L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber™ implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber™ Compression Screws are supplied sterile, for single patient use only, and are available in several sizes: 26-60 mm long, and 3.5-6.5 mm diameter. The screws are partially threaded, cannulated design.
The OSSIOfiber™ Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5853/ISO 9714 compatible instrumentations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity, fibula, knee, ankle and foot
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, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of pull-out and flexural bending was performed to verify the fixation and strength properties of the OSSIOfiber™ Compression Screw, and to compare them to those of the predicate device (K123672). Pull out properties were also compared to those of the metal referenced device (K1616). Testing was done initially and following in-vitro degradation. Torsional strength and driving torque at time zero were also conducted for the OSSIOfiber™ Compression Screw.
Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared reference devices (K181180, K190652) as well as a rationale. A rationale was provided to support the MR safe labeling of the device.
Non-clinical testing data demonstrate that the OSSIOfiber™ Compression Screw is at least as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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July 30, 2020
Ossio Ltd. % David McGurl Director, Regulatory Affairs MCRA. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K193660
Trade/Device Name: OSSIOfiber™ Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 30, 2020 Received: June 30, 2020
Dear David McGurl:
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, MPH 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
OSSIOfiber™ Compression Screw
Indications for Use (Describe)
OSSIOfiber™ Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY OSSIOfiber™ Compression Screw
Submitter
Ossio Ltd.
8 HaTochen Street, Caesarea, Israel, 3079861 Phone: +972-4-9986600 Facsimile: +972-4-9986601 Contact Person: Taly Lindner
Date Prepared: July 28, 2020
Name of Device: OSSIOfiber™ Compression Screw
Common or Usual Name: Screw, Fixation, Bone
Classification Name: Smooth or threaded metallic bone fixation fastener
Regulatory Class: Class II, 21 C.F.R. § 888.3040
Product Code: HWC
Predicate Devices
Inion FreedomScrew™ (K123672) - Primary Predicate
DePuy Synthes 3.5 mm Cannulated Screw (K161616)
Arthrex Bio-compression Screw (K060478)
Reference Devices
OSSIO™ Pin Product Family (K181180)
OSSIOfiber™ Hammertoe Fixation Implant (K190652)
Device Description
The OSSIOfiber™ Compression Screws are cannulated bone screws made of degradable poly (Llactide-co-D. L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from minerals that are found in natural bone. As the OSSIOfiber™ implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber™ Compression Screws are supplied sterile, for single patient use only, and are available in several sizes: 26-60 mm long, and 3.5-6.5 mm diameter. The screws are partially threaded, cannulated design.
The OSSIOfiber™ Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5853/ISO 9714 compatible instrumentations.
Indications for Use
The OSSIOfiber™ Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the
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upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.
Summary of Technological Characteristics
The OSSIOfiber™ Compression Screws have the same intended use and principles of operation, similar indications for use, design characteristic, and material composition, as the predicate device Inion FreedomScrew™ (K123672). Both the device and the predicate are supplied sterile. The OSSIOfiber™ Compression Screw is sterilized by EtO whereas the predicate is sterilized by Gamma. Both device and predicate are degradable. The polymer material of the OSSIOfiber™ Compression Screw is the same as the polymeric material of the previously cleared primary predicate. The device also contains continuous mineral fibers whereas the predicate is only polymeric material. The OSSIOfiber™ Compression Screws and predicate are available in similar design and sizes, where the subject device includes larger diameters and a slightly more limited set of screw designs than the predicate device. Although there are differences with regards to shape and size as compared to the predicate, mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation. Any differences between OSSIOfiber™ Compression Screw and its predicate device do not raise different questions of safety and effectiveness.
Non-Clinical Data
Mechanical testing of pull-out and flexural bending was performed to verify the fixation and strength properties of the OSSIOfiber™ Compression Screw, and to compare them to those of the predicate device (K123672). Pull out properties were also compared to those of the metal referenced device (K1616). Testing was done initially and following in-vitro degradation. Torsional strength and driving torque at time zero were also conducted for the OSSIOfiber™ Compression Screw.
Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared reference devices (K181180, K190652) as well as a rationale. A rationale was provided to support the MR safe labeling of the device.
Conclusions
The OSSIOfiber™ Compression Screw is as safe and effective as its predicate device, Inion FreedomScrew™ (K123672). The OSSIOfiber™ Compression Screws have the same intended use and principles of operation, similar indications for use, design characteristic, and material composition, as the predicate device Inion FreedomScrew™ (K123672). The minor differences do not alter the intended surgical use of the device and do not affectiveness when used as labeled. Non-clinical testing data demonstrate that the OSSIOfiber™ Compression Screw is at least as safe and effective as the predicate device. Thus, the OSSIOfiber™ Compression Screw is substantially equivalent.