(114 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant and associated instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, which are conditions that impair normal body function and require intervention to restore it. This aligns with the definition of a therapeutic device.
No
The device is an implantable system used for surgical fixation of fractures, fusions, and osteotomies of the toes. It aids in treatment and recovery, rather than diagnosing a condition.
No
The device description clearly states the device is an implant manufactured from PEEK, which is a physical material, not software. It also describes associated instruments for implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the fixation of fractures, fusions, and osteotomies of the toes. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implant made of PEEK, designed to be press-fit into bone. It is a physical device used for structural support within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is clearly an implantable surgical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
Product codes
HWC
Device Description
The CrossTie™ Intraosseous Fixation System is manufactured from implant grade PEEK. The implant is a one-piece construct designed to be press-fit into the intraosseous space of two adjoining bones to aid in fusion. The proximal and distal ends of the implant have barb-type features for securing the implant in position. The implant also features a hole in the distal end of the implant to be used at the surgeon's discretion to assist in joint reduction. Furthermore, the surgeon may optionally elect to use suture that passes through the distal end of the implant for closure.
The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.
The design features of the CrossTie™ Intraosseous Fixation System are summarized below:
- O Implant Grade PEEK
- O Sized to accommodate patient anatomy
- Solid, one piece construction for all devices O
- Proximal and distal barb-like features for secure placement O
- Hole to optionally aid in joint reduction O
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
toes
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
The CrossTie™ Intraosseous Fixation System utilizes materials and has design features that are the same as the predicate device. Evaluation of the system with and without utilizing the suture for closure demonstrates that the subject device is substantially equivalent in static and fatigue performance compared to the predicate device. The implant has been cyclic tested with and without suture to demonstrate that the device can withstand the expected loads.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2015
CrossRoads Extremity Systems LLC Mr. Vernon Hartdegen Senior Vice President of Operations 6055 Primacy Parkway, Suite 140 Memphis. Tennessee 38119
Re: K151270
Trade/Device Name: CrossTie™ Intraosseous 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 12, 2015 Received: June 15, 2015
Dear Mr. Hartdegen:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Vernon Hartdegen
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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See PRA Statement below.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
510(k) Number (if known) K151270
Device Name
CrossTie™ Intraosseous Fixation System
Indications for Use (Describe)
The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
| 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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Attachment 6
510(k) Summary CrossTie™ Intraosseous Fixation System
| Date of Submission | September 3, 2015 |
|---|---|
| Official Contact/Address of | |
| Manufacturing Facility | Vernon R Hartdegen |
| Sr. Vice President of Operations | |
| CrossRoads Extremity Systems LLC | |
| 6055 Primacy Parkway, Suite 140 | |
| Memphis, TN 38119 | |
| Phone: 901-221-8406 | |
| Fax: n/a | |
| vhartdegen@crextremity.com | |
| Proprietary Name | CrossTie™ Intraosseous Fixation System |
| Device Classification Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | HWC |
| Classification Reference | 21 CFR 888.3040 |
| Classification | Class II |
| Appropriate Classification Panel | 87 - Orthopedic |
| Predicate Devices | K141857 CrossTIE™ Intraosseous Fixation System |
| Reason For Submission | Update to Surgical Technique |
Substantial Equivalence:
The modified fixation system has the following similarities to the previously cleared predicate device:
- Same Operating Principle O
- O Same Technology
- Same Intended Use O
Design verification analysis was performed on the CrossTie™ Intraosseous Fixation System as a result of the risk analysis and product requirements. All analyses were verified to meet the required acceptance criteria. The subject device is the same as the predicate device (K141857),
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Image /page/4/Picture/0 description: The image shows the logo for "CrossRoads Extremity Systems". The logo consists of a square made up of four smaller squares in blue and green colors, followed by the text "CrossRoads" in gray. Below the text "CrossRoads" is the text "Extremity Systems" in a smaller font size, also in gray.
with respect to materials, indications and technical characteristics. The only noted difference from the predicate device is the surgical technique allows the surgeon to use the suture for closure after joint reduction. This minor difference is insignificant in the safety and efficacy of the devices. In summary, the subject device described in this submission is substantially equivalent to the predicate device.
Indications for Use:
The indications for use are the same as the previously cleared indications for use for the CrossTie™ Intraosseous Fixation System: The CrossTie™ Intraosseous Fixation System is indicated to aid in the fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
Device Description:
The CrossTie™ Intraosseous Fixation System is manufactured from implant grade PEEK. The implant is a one-piece construct designed to be press-fit into the intraosseous space of two adjoining bones to aid in fusion. The proximal and distal ends of the implant have barb-type features for securing the implant in position. The implant also features a hole in the distal end of the implant to be used at the surgeon's discretion to assist in joint reduction. Furthermore, the surgeon may optionally elect to use suture that passes through the distal end of the implant for closure.
The instruments needed for implantation consist of a reamer for implant site preparation and a driver for insertion. All associated instruments are Class I.
The design features of the CrossTie™ Intraosseous Fixation System are summarized below:
- O Implant Grade PEEK
- O Sized to accommodate patient anatomy
- Solid, one piece construction for all devices O
- Proximal and distal barb-like features for secure placement O
- Hole to optionally aid in joint reduction O
Performance Testing:
The CrossTie™ Intraosseous Fixation System utilizes materials and has design features that are the same as the predicate device. Evaluation of the system with and without utilizing the suture for closure demonstrates that the subject device is substantially equivalent in static and fatigue performance compared to the predicate device. The implant has been cyclic tested with and without suture to demonstrate that the device can withstand the expected loads.