(118 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical instrumentation, with no mention of AI or ML.
No
The device, OsteoCentric ACL Fixation Fasteners, provides bone fixation in orthopedic procedures, specifically for ACL and PCL reconstruction of the knee. While it aids in a medical procedure, it is an implantable device used for mechanical fixation rather than administering therapy or directly treating a disease or condition in a therapeutic manner. Its function is primarily structural support.
No
Explanation: The device is described as a fastener system used for bone fixation in orthopedic procedures, specifically ACL and PCL reconstruction. Its function is to maintain the fixation of grafts, not to diagnose a condition or disease.
No
The device description explicitly details physical hardware components including titanium fasteners, stainless steel instruments, and a nitinol guidewire.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The OsteoCentric ACL Fixation Fasteners are used to physically fix bone-tendon-bone grafts during orthopedic surgery. They are implanted directly into the body to provide structural support.
- Intended Use: The intended use clearly states "to provide bone fixation in orthopedic procedures." This is a surgical function, not a diagnostic one.
- Device Description: The description details the physical components of the fasteners and instruments used for implantation. There is no mention of analyzing biological samples.
The device is a surgical implant and associated instrumentation, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The OsteoCentric ACL Fixation Fasteners are used to provide bone fixation in orthopedic procedures, including bonetendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The OsteoCentric ACL Fastener System consists of ACL Fixation Fasteners and select singleuse and reusable instrumentation to facilitate implantation.
The ACL Fixation Fasteners are threaded titanium interference screws with a tapered tip for easy insertion into bone. The fasteners are cannulated to allow the use of a guidewire to assist with placement of the fastener into the bone tunnel. The fastener is used to maintain the fixation of bone-tendon-bone grafts in orthopedic procedures. The ACL Fixation Fasteners are provided sterile.
ACL Fixation single-use instruments are: a 2.4mm OD stainless steel drill-tipped passing pin, a 1.6mm OD nitinol guidewire, and a stainless-steel graft retractor. The ACL single-use instruments are provided sterile.
ACL Fixation reusable instruments are: a 2.5mm hex driver, and a 3.5mm Hex Driver. The ACL Fixation reusable instruments are provided non-sterile and must be sterilized prior to use.
The OsteoCentric ACL Fixation Fastener System Sterile implants are evaluated to be nonpyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
The following testing and analysis were performed:
- The Torsional Properties (ASTM F543 Annex A1)
- Driving Torque and Removal Torque (ASTM F543 Annex A2)
- Engineering analysis comparison of theoretical axial pullout
- Axial Pushout
Test results and analysis provide objective evidence that the subject device is substantially equivalent to a legally marketed predicate.
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.
Not Found
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
June 29, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OsteoCentric Technologies Todd Evans Senior Director of Quality & Regulatory Affairs 75 West 300 North Suite 150 Logan, Utah 84321
Re: K230595
Trade/Device Name: OsteoCentric ACL Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 1, 2023 Received: June 8, 2023
Dear Todd Evans:
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,
Jesse Muir -S
Jesse Muir, PhD 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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Indications for Use
510(k) Number (if known) K230595
Device Name OsteoCentric ACL Fixation System
Indications for Use (Describe)
The OsteoCentric ACL Fixation Fasteners are used to provide bone fixation in orthopedic procedures, including bonetendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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------------------------------------------------------------------------------------------------ | --------------------------------------------- |
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510(k) Summary
I. Submitter Information
Manufacturer:
OsteoCentric Technologies 75 West 300 N, Suite 150 Logan, UT 84321 Phone: 1-800-969-0639
Contact Person:
Todd Evans, Senior Director of Quality and Regulatory Affairs OsteoCentric Technologies
II. Device
Device Proprietary Name: | OsteoCentric ACL Fixation Fastener System |
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Common or Usual Name: | ACL Fastener System |
Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
Regulation Number: | 21 CFR 888.3040 |
Product Code: | HWC |
Device Classification: | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- Primary Predicate: ConMed EZStart, Interference Screw, K182955 ●
- Additional Predicate: Arthrex Titanium Interference Screws, K052607
IV. Device Description
The OsteoCentric ACL Fastener System consists of ACL Fixation Fasteners and select singleuse and reusable instrumentation to facilitate implantation.
The ACL Fixation Fasteners are threaded titanium interference screws with a tapered tip for easy insertion into bone. The fasteners are cannulated to allow the use of a guidewire to assist with placement of the fastener into the bone tunnel. The fastener is used to maintain the fixation of bone-tendon-bone grafts in orthopedic procedures. The ACL Fixation Fasteners are provided sterile.
ACL Fixation single-use instruments are: a 2.4mm OD stainless steel drill-tipped passing pin, a 1.6mm OD nitinol guidewire, and a stainless-steel graft retractor. The ACL single-use instruments are provided sterile.
ACL Fixation reusable instruments are: a 2.5mm hex driver, and a 3.5mm Hex Driver. The ACL Fixation reusable instruments are provided non-sterile and must be sterilized prior to use.
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The OsteoCentric ACL Fixation Fastener System Sterile implants are evaluated to be nonpyrogenic.
V. Indications for Use
The OsteoCentric ACL Fixation Fasteners are Used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
VI. Comparison of Technological Characteristics
The subject device and predicate device have the same intended use and technological characteristics. Both interference screws are titanium, tapered tip, and cannulated. Both interference screws are used to maintain fixation of bone-tendon-bone grafts in orthopedic procedures.
VII. Performance Data
The following testing and analysis were performed:
- · The Torsional Properties (ASTM F543 Annex A1)
- · Driving Torque and Removal Torque (ASTM F543 Annex A2)
- · Engineering analysis comparison of theoretical axial pullout
- Axial Pushout
VIII. Conclusion
Test results and analysis provide objective evidence that the subject device is substantially equivalent to a legally marketed predicate.