(242 days)
No
The description focuses on the material properties and mechanical function of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a cannulated bone screw used for fixation and alignment of bone fractures, osteotomies, and bone grafts, which serves a structural and supportive role rather than directly providing therapy.
No
The device is a compression screw used for fixation of fractures and osteotomies, which is a therapeutic function, not diagnostic.
No
The device description clearly states the device is a physical bone screw made of degradable materials, not software.
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 "maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts." This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implantable device (bone screws) made of degradable materials. This is consistent with a surgical implant, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The OSSIOfiber® Compression Screws are used to physically stabilize bone, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
OSSIOftber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.
Product codes (comma separated list FDA assigned to the subject device)
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. The screws are partially threaded and have a cannulated design. The additional devices included in this submission are: 65 - 100 mm long, and 6.5 mm diameter.
The OSSIOfiber® Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5835/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)
Non-Clinical Data: Additional chemical characterization testing has been completed, and together with a toxicological risk assessment support the subject longer screw lengths. Additional mechanical performance testing was not performed as the subject lengths do not present a new worst case for the OSSIOfiber® Compression Screw family.
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.
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.
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
§ 888.3040 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.
0
December 23, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.
OSSIO Ltd. % David Mcgurl Director, Regulatory Affairs Mcra. LLC 803 7th Street North West, Floor 3 Washington, District of Columbia 20001
Re: K221193
Trade/Device Name: OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 30, 2022 Received: November 30, 2022
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.
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
1
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 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-S
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
2
Indications for Use
510(k) Number (if known)
Device Name
OSSIOfiber® Compression Screw
Indications for Use (Describe)
OSSIOftber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
OSSIOfiber® Compression Screw, 6.5mm
Submitter
Ossio Ltd.
8 HaTochen Street, Caesarea, Israel, 3079861 Phone: +972-4-9986600 Facsimile: +972-4-9986601 Contact Person: Taly Lindner
Date Prepared: November 30, 2022
Name of Device: OSSIOfiber® Compression Screw, 6.5mm 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
OSSIOfiber® Compression Screw (K193660) - Primary Predicate
Reference Devices
Inion CompressOn™ Screw (K203105) OSSIOfiber® Compression Screw (K213596)
Purpose of Submission
This traditional 510(k) premarket notification is being submitted to obtain clearance for a line extension, made from the same material of longer lengths, outside the previously cleared range of the OSSIOfiber® Compression Screw family (named OSSIOfiber® Compression Screw, 6.5mm).
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. The screws are partially threaded and have a cannulated design. The additional devices included in this submission are: 65 - 100 mm long, and 6.5 mm diameter.
4
The OSSIOfiber® Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5835/ISO 9714 compatible instrumentations.
Indications for Use
OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, and bone grafts, of the 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, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K193660). The additional lengths of the OSSIOffiber® Compression Screws, 6.5mm do not introduce a new performance worst-case relative to the cleared primary predicate. The additional longer lengths of the subject device are similar to those of the Inion CompressOn™ Screw (K203105) which is cleared for similar indications with similar principles of operation and technological characteristics. Additional characterization testing has been completed, and together with a toxicological risk assessment support these additional lengths. Thus, any differences between OSSIOfiber® Compression Screws, 6.5mm and its predicate device do not raise different questions of safety and effectiveness.
Non-Clinical Data
Additional chemical characterization testing has been completed, and together with a toxicological risk assessment support the subject longer screw lengths. Additional mechanical performance testing was not performed as the subject lengths do not present a new worst case for the OSSIOfiber® Compression Screw family.
Conclusions
The OSSIOfiber® Compression Screws have the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K193660). The additional lengths do not alter the intended surgical use of the device and does not affect its safety and effectiveness when used as labeled. The additional lengths vs the predicate device raises no new issues of safety or effectiveness as supported by the chemical characterization data and toxicological risk assessment. The OSSIOfiber® Compression Screws is as safe and effective as its predicate device. Thus, the OSSIOfiber® Compression Screws is substantially equivalent to the predicate device.