(359 days)
No
The summary describes a physical implant and associated instruments for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for "maintenance of alignment and fixation of bone fractures, osteotomies, and bone grafts," which implies a therapeutic use to aid in the healing and stabilization of these conditions.
No
The device is described as an implant system for the fixation of bone fractures and osteotomies, not for identifying a disease or condition. Its function is to provide structural support for healing.
No
The device description clearly details physical implants made of degradable material and surgical instruments (drill bit, k-wire), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "maintenance of alignment and fixation of bone fractures, osteotomies, and bone grafts". This describes a surgical implant used within the body to support bone healing.
- Device Description: The description details a physical implant made of a degradable material, designed to be inserted into bone. This is a medical device used for structural support.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
The OSSIOfiber™ Hammertoe Fixation System/Implant is a surgical implant, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
The OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Product codes
HTY
Device Description
The OSSIOfiber™ Hammertoe Fixation Systems\OSSIOfiber™ Hammertoe Fixation Implants include implants that have a ribbed design that is inserted between the proximal and middle phalanges, so the ribs fixate on the phalangeal canal of the toe. The OSSIOfiber™ Hammertoe fixation implants are made of OSSIOfiber " material which is 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 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™ Hammertoe Fixation Implants are supplied sterile, pre-mounted on an implant inserter, offered in straight and 10-degree variations, and are available in several sizes: 16-21 mm long and 2.5-3.2 mm nominal diameter.
The OSSIOfiber™ Hammertoe Fixation System is a sterile kit which includes in addition to the implant pre-mounted on an inserter, a drill bit and a k-wire which are the instrumentations required for the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures, osteotomies, 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
Mechanical testing of flexural bending, shear and pull-out was performed to verify the strength and fixation properties of the OSSIOfiber™ Hammertoe Fixation System, and to compare them to those of the predicate device. Testing was conducted initially and after in vitro degradation.
In vitro decradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over the 12week healing period. Testing included weight loss, decrease in molecular weight, flexural strength testing, shear strength testing, and pullout testing over 12 weeks.
Material biocompatibility for the implants and instruments was primarily established by use of material identical to the predicate or use of well-established material. Additional testing of cytotoxicity and pyrogenicity (LAL) testing was performed on final, finished products. A rationale was provided to support the MR safe labeling of the device.
Stainless steel instruments were tested for resistance to corrosion and met the relevant acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
OSSIO™ Pin Product Family (K181180)
Reference Device(s)
Arthrex PIP Dart (K141577)
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.
0
Image /page/0/Picture/0 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue rectangle and the full name in a lighter shade of blue below it. The seal features an emblem with a staff and serpent, symbolizing healing and medicine.
March 6, 2020
Ossio Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K190652
Trade/Device Name: OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: February 25, 2020 Received: February 25, 2020
Dear Janice Hogan:
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.
1
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 (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 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.
for
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K190652
Device Name
OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant
Indications for Use (Describe)
The OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
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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3
510(k) SUMMARY
OSSIOfiber™ Hammertoe Fixation System
Submitter
Ossio Ltd.
8 HaTochen Street, Caesarea, Israel, 3079861
Phone: +972-4-9986600 Facsimile: +972-4-9986601
Contact Person: Taly Lindner Date Prepared: March 13, 2019
Name of Device: OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant
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
Primary Predicate Devices
OSSIO™ Pin Product Family (K181180)
Reference Devices
Arthrex PIP Dart (K141577)
Device Description
The OSSIOfiber™ Hammertoe Fixation Systems\OSSIOfiber™ Hammertoe Fixation Implants include implants that have a ribbed design that is inserted between the proximal and middle phalanges, so the ribs fixate on the phalangeal canal of the toe. The OSSIOfiber™ Hammertoe fixation implants are made of OSSIOfiber " material which is 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 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.
4
The OSSIOfiber™ Hammertoe Fixation Implants are supplied sterile, pre-mounted on an implant inserter, offered in straight and 10-degree variations, and are available in several sizes: 16-21 mm long and 2.5-3.2 mm nominal diameter.
The OSSIOfiber™ Hammertoe Fixation System is a sterile kit which includes in addition to the implant pre-mounted on an inserter, a drill bit and a k-wire which are the instrumentations required for the procedure.
Indications for Use
The OSSIOfiber™ Hammertoe Fixation System\OSSIOfiber™ Hammertoe Fixation Implant is 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 10 Hammertoe Fixation System has the same intended use, indications for use and material composition, and very similar design characteristic and principles of operation as the predicate device OSSIO™ Pin Product Family (K181180). The OSSIOfiber™ Hammertoe Fixation System's biocomposite material as well as the manufacturing techniques are the same as that of the cleared predicate. Both the device and the predicate are supplied sterile and are sterilized by EtC. Although there are differences in 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™ Hammertoe Fixation System and its predicate device do not raise different questions of safety and effectiveness.
Performance Data
Mechanical testing of flexural bending, shear and pull-out was performed to verify the strength and fixation properties of the OSSIOfiber™ Hammertoe Fixation System, and to compare them to those of the predicate device. Testing was conducted initially and after in vitro degradation.
In vitro decradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over the 12week healing period. Testing included weight loss, decrease in molecular weight, flexural strength testing, shear strength testing, and pullout testing over 12 weeks.
Material biocompatibility for the implants and instruments was primarily established by use of material identical to the predicate or use of well-established material. Additional testing of cytotoxicity and pyrogenicity (LAL) testing was performed on final, finished products. A rationale was provided to support the MR safe labeling of the device.
Stainless steel instruments were tested for resistance to corrosion and met the relevant acceptance criteria.
5
Conclusions
The OSSIOfiber™ Hammertoe Fixation System and OSSIOfiber™ Hammertoe Fixation Implant is substantially equivalent to its predicate device, OSSIO™ Pin Product Family (K181180). The OSSIOfiber™ Hammertoe Fixation Implant has the same intended uses, indications of use and material composition and similar technological characteristics and principles of operation as its predicate device. The minor differences do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. Non-clinical testing data demonstrate that the OSSIOfiber™ Hammertoe Fixation System is substantially equivalent to the predicate device. Thus, the OSSIOfiber™ Hammertoe Fixation System is substantially equivalent.