(180 days)
No
The summary describes a physical fixation device made of degradable materials and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is indicated for "maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts," which directly treats or alleviates a condition.
No
Explanation: The device is described as a fixation device used for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a physical fixation device made of degradable materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes the OSSIOfiber® Cannulated Trimmable Fixation Nails as implants used for the mechanical fixation and alignment of bone fractures, osteotomies, arthrodesis, and bone grafts. They are physically inserted into the body to provide structural support during healing.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, detect substances, or provide any diagnostic information about a patient's condition. Its function is purely structural and supportive.
Therefore, based on the provided information, the OSSIOfiber® Cannulated Trimmable Fixation Nails are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The OSSIOfiber® Cannulated Trimmable Fixation Nails are fixation devices made of degradable poly (L-lactide-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 materials 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® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. The additional device included in this submission is 100 mm long and 3.5mm core diameter (4.0 mm outer diameter).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures, osteotomies, arthrodesis, and bone grafts
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 performance testing was not performed as the subject device does not represent a new mechanical performance worst-case for the OSSIOfiber® Cannulated Trimmable Fixation Nail cleared family. The technological characteristics of the subject device vs the predicate device remain identical aside from the longer length.
Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared predicate (K203465) and reference devices (K181180, K221193) as well as a rationale. The MR safe labeling of the device was established based on the cleared predicate device's labeling.
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
September 13, 2023
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Ossio Ltd. % David McGurl Vice President, Regulatory Affairs- Orthopedics MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K230750
Trade/Device Name: OSSIOfiber® Cannulated Trimmable Fixation Nail Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: August 16, 2023 Received: August 16, 2023
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 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,
Colin
O'neill - FDA
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K230750
Device Name
OSSIOfiber® Cannulated Trimmable Fixation Nail
Indications for Use (Describe)
OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
X 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® Cannulated Trimmable Fixation Nail
Submitter
Ossio Ltd.
8 HaTochen Street, Caesarea, Israel, 3079861 Phone: +972-4-9986600 Facsimile: +972-4-9986601 Contact Person: Taly Lindner Date Prepared: March 17, 2023
Name of Device: OSSIOfiber® Cannulated Trimmable Fixation Nail
Common or Usual Name: fixation, pin, smooth
Classification Name: Smooth or threaded metallic bone fixation fastener
Regulatory Class: Class II, 21 C.F.R. § 888.3040
Product Code: HTY
Predicate Devices
OSSIOfiber® Cannulated Trimmable Fixation Nail (K203465)
Reference Devices
- . Arthrex Bio-pin (K050259)
- OSSIOfiber® Compression Screw, 6.5mm (K221193) .
- OSSIO® Pin Product Family (K181180) .
Purpose of Submission
This traditional 510(k) premarket notification is submitted to obtain clearance for an additional device having the same design characteristics, made of the same material, but longer and outside the previously cleared range of the OSSIOfiber® Cannulated Trimmable Fixation Nail family (K203465).
Device Description
The OSSIOfiber® Cannulated Trimmable Fixation Nails are fixation devices made of degradable poly (L-lactide-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 materials 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
4
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® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. The additional device included in this submission is 100 mm long and 3.5mm core diameter (4.0 mm outer diameter).
The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instrumentations.
Indications for Use
OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Summary of Technological Characteristics
The OSSIOfiber® Cannulated Trimmable Fixation Nails have the same intended use, indications for use, material composition, design characteristics, manufacturing and sterilization methods and principles of operation as the predicate device (K203465). The additional length of the OSSIOfiber® Cannulated Trimmable Fixation Nail, does not introduce a new performance worst-case relative to the cleared predicate. The longer length of the subject device is similar to the Arthrex Bio-pin device (K050259) which is cleared for similar indications with similar principles of operation and design characteristics. The longer length of the subject device is also similar to the longest OSSIOfiber® Compression Screw, 6.5mm (K221193) which is made of the same material composition and is cleared for similar indications with similar principles of operation and design characteristics.
Both the device and the predicate are supplied sterile and sterilized by EtO.
Non-Clinical Data
Non-clinical performance testing was not performed as the subject device does not represent a new mechanical performance worst-case for the OSSIOfiber® Cannulated Trimmable Fixation Nail cleared family. The technological characteristics of the subject device vs the predicate device remain identical aside from the longer length.
Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared predicate (K203465) and reference devices (K181180, K221193) as well as a rationale. The MR safe labeling of the device was established based on the cleared predicate device's labeling.
5
Conclusions
The OSSIOfiber® Cannulated Trimmable Fixation Nails have the same intended use, indications for use, material composition, principles of operation, and design characteristics as the predicate device (K203465). The additional length of the OSSIOfiber® Cannulated Trimmable Fixation Nail, does not alter the intended surgical use of the device and does not affect its safety and effectiveness when used as labeled. The additional length does not represent a new worst-case for the OSSIOfiber® Cannulated Trimmable Fixation Nail family and does not raise of safety or effectiveness. Thus, the OSSIOfiber® Cannulated Trimmable Fixation Nail is substantially equivalent to the predicate device.