(97 days)
Not Found
No
The summary describes a mechanical implant for spinal support and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vertebral body replacement system intended to replace damaged vertebral bodies due to tumor or trauma to provide structural support, which is a therapeutic function.
No
The device is a vertebral body replacement device, providing structural stability after a corpectomy or vertebrectomy, not for diagnosing conditions.
No
The device description clearly states that the CAPRI Corpectomy Cage System is comprised of physical implants made from titanium alloy and cobalt chrome, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CAPRI Corpectomy Cage System Function: The description clearly states that the CAPRI Corpectomy Cage System is a vertebral body replacement device used to provide structural stability in the spine after surgical removal of a vertebral body. It is an implantable device used in the body, not a device used to test specimens from the body.
The information provided about the device's intended use, description, mechanical testing, and predicate devices all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The CAPRI Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Product codes
MQP
Device Description
The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium alloy) and adjustable (titanium alloy and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium alloy (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).
Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5)
Indicated Patient Age Range
skeletally mature individuals
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 CAPRI Corpectomy Cage System was mechanically tested and compared to predicate devices. The CAPRI Corpectomy Cage System performed equally to or better than these systems in static compression, static torsion, dynamic compression and dynamic torsion (per ASTM F2077), subsidence per ASTM F2267 and expulsion.
Key Metrics
Not Found
Predicate Device(s)
K142016, K111294, K150481, K160125, K012254
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(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
April 13, 2017
K2M, Inc. Ms. Nancy Giezen Manager, Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K170055
Trade/Device Name: CAPRI Corpectomy Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: March 13, 2017 Received: March 14, 2017
Dear Ms. Giezen:
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 devicerelated 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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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" (21 CFR 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,
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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Indications for Use
510(k) Number (if known) K170055
Device Name CAPRI Corpectomy Cage System
Indications for Use (Describe)
The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The CAPRI Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
| 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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510(k) SUMMARY CAPRI Corpectomy Cage System
Submitter
K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 03/13/2017
Classification
| Trade Name: | CAPRI Corpectomy Cage System |
|---|---|
| Common Name: | Vertebral Body Replacement Device |
| Regulatory Class: | Class II |
Classification Name(s): Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060, Product Code MQP)
Predicate Device(s)
Primary Predicate:
- K2M CAPRI Corpectomy Cage System (K142016) ● Additional Predicates:
Device Description
The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid (titanium alloy) and adjustable (titanium alloy and cobalt chrome) cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium alloy (per ASTM F3001) and Cobalt Chrome (per ASTM F1537).
Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.
Intended Use
The CAPRI Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (i.e. fracture). The CAPRI Corpectomy Cage System is designed to
4
provide anterior spinal column support even in the absence of fusion for a prolonged period. The CAPRI device may be used with allograft or autograft.
For all the above indications the CAPRI implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems
Technological Comparison to Predicate(s)
The CAPRI Corpectomy Cage System was compared to predicate systems and the design features, materials and sizes were found to be substantially the same as these systems.
Non-clinical Performance Evaluation
The CAPRI Corpectomy Cage System was mechanically tested and compared to predicate devices. The CAPRI Corpectomy Cage System performed equally to or better than these systems in static compression, static torsion, dynamic compression and dynamic torsion (per ASTM F2077), subsidence per ASTM F2267 and expulsion.
Conclusion
There are no significant differences between the CAPRI Corpectomy Cage System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.