(31 days)
No
The summary describes a mechanical implant system made of Nitinol and associated instruments. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is implanted to fix bone fragments and fuse joints, which directly addresses a medical condition (e.g., fractures, deformities) to restore function or provide stability, aligning with the definition of a therapeutic device.
No
The device description focuses on orthopedic fixation, specifically for bone fragment osteotomy fixation and joint arthrodesis, which are treatments rather than diagnostic procedures. There is no mention of identifying, detecting, or measuring a medical condition.
No
The device description clearly states it is an implant system made of nickel titanium alloy and includes physical instruments for implantation. It is a hardware device.
Based on the provided information, the CrossCLIP™ Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "hand and foot bone fragment osteotomy fixation and joint arthrodesis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implant made of nickel titanium alloy, designed to be surgically implanted into bones.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or assays.
The CrossCLIP™ Implant System is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Product codes
JDR
Device Description
The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices.
The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I.
The design features of the CrossCLIP™ Implant System are summarized below:
- Implant Grade Nitinol (ASTM F2063-12)
- Various sizes to accommodate patient anatomy
- One piece construction
- Barbs to resist pull-out
- Single use, sterile packaged instruments
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot bone
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 CrossCLIP™ implants have been verified against the predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K070031 - MemoMetal Memory Staples (MemoClip - EasyClip - For Fusion); MemoMetal Technologies, K124045 – FuseForce Implant System; Solana Surgical, LLC
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
OthoDiscovery Group, LLC (D.B.A. CrossRoads Extremity Systems) Mr. Vernon Hartdegen Sr. Vice President of Operations 458 Distribution Parkway Collierville, Tennessee 38017
Re: K142727 Trade/Device Name: CrossCLIP™ Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: September 25, 2014 Received: September 30, 2014
Dear Mr. Vernon 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
1
Page 2 - Mr. Vernon Hartdegen
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.
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/Resourcesfor You/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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
CrossCLIPTM Implant System
Indications for Use (Describe)
The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
| Date of Submission | September 25, 2014 |
|---|---|
| Official Contact/Address of | |
| Manufacturing Facility | Vernon R Hartdegen |
| Sr. Vice President of Operations | |
| OrthoDiscovery Group, LLC | |
| 458 Distribution Parkway | |
| Collierville, TN 38017 | |
| Phone: 901-221-8406 | |
| Fax: N/A | |
| vhartdegen@crextremity.com | |
| Proprietary Name | CrossCLIP™ Implant System |
| Device Classification Name | Staple, Fixation, Bone |
| Product Code | JDR |
| Classification Reference | 21 CFR 888.3030 |
| Classification | Class II |
| Appropriate Classification Panel | 87 - Orthopedic |
| Predicate Devices | K070031 - MemoMetal Memory Staples (MemoClip - EasyClip - |
| For Fusion); MemoMetal Technologies | |
| K124045 – FuseForce Implant System; Solana Surgical, LLC | |
| Reason For Submission | New Device |
5 – 510(k) Summary CrossCLIP™ Implant System
Substantial Equivalence:
The new device has the following similarities to the previously cleared predicate devices:
- Same Operating Principle o
- Same Technology o
- Same Intended Use o
Design verification analysis was performed on the CrossCLIP™ Implant System as a result of the risk analysis and product requirements. Results of the design verification activities met the required acceptance criteria. In summary, the device described in this submission is substantially equivalent to the predicate device. The subject device is similar in material, operating principle and intended use to both identified predicates. The subject device primarily differs from the predicates in the manner of the attachment of the implant to the insertion
4
device/delivery instrument. The predicate devices both rely on insertion/delivery instrumentation and techniques that requires the delivery instrument to attach underneath the bridge of the staple. This prevents the staple from fully seating on the surface of the bone. Due to this, once the staple is released from its inserter and the legs are allowed to converge, the staple must then undergo a final seating with an ancillary instrument. The subject device implant is not held underneath the staple bridge rather the inserter engages the staple leg thereby allowing the implant to be fully seated on the bone prior to being released from the inserter/delivery instrument. Both the subject and predicate devices have barbs on the internal surface of the staple legs to resist pullout. In addition, certain sizes of the subject implant include a barb-like feature on the outside of the staple leg to resist pullout. Neither of these differences adversely affect the safety of the device as demonstrated by the verification analysis. The subject and predicate devices both utilize the same mechanism of action, i.e. the superelastic material property of nitinol, to generate compression between the staple legs. The minor differences between the subject and predicate devices are insignificant in the safety and efficacy of the devices. In summary, the subject device described in this submission is substantially equivalent to the predicate devices.
Indications for Use:
The CrossCLIP™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.
Device Description:
The CrossCLIP™ Implant System is manufactured from nickel titanium alloy (ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants). The implants are one-piece devices designed to be implanted into the bones of the hand or foot for fragment osteotomy fixation and joint arthrodesis. The staple legs have barb-type features on the inside and outside of the legs to resist pullout. The implants are available in a range of sizes similar to the predicate devices.
The instruments needed for implantation consist of an implant inserter, drill/reamer guide, drill/reamer and provisional fixation pin. The implant inserter is considered a Class II instrument. All other instruments are Class I.
The design features of the CrossCLIP™ Implant System are summarized below:
- Implant Grade Nitinol (ASTM F2063-12) o
- O Various sizes to accommodate patient anatomy
- o One piece construction
- Barbs to resist pull-out O
- O Single use, sterile packaged instruments
5
Performance Testing:
The CrossCLIP™ implants have been verified against the predicate device (K070031 – MemoMetal Memory Staples MemoClip – For Fusion; MemoMetal Technologies) and ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The completed analysis has shown that the performance of the subject device is substantially equivalent to the predicate devices.