(104 days)
K2M Pedicle Screw and Hook Systems, K2M Spinal Plate Systems
No
The summary describes a mechanical implant for spinal support and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to treat conditions like tumor or trauma affecting the vertebral bodies, which aligns with the definition of a therapeutic device designed to alleviate or cure medical conditions.
No
Explanation: The device is a vertebral body replacement device intended for structural support, not for diagnosing medical conditions.
No
The device description clearly states it is a hollow tube structure manufactured from Ti6Al4V ELI and Co-Cr-Mo, which are physical materials, not software. It is a vertebral body replacement device, a physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- CAPRI Corpectomy Cage System Function: The CAPRI Corpectomy Cage System is a surgical implant designed to replace a damaged vertebral body in the spine. It is a physical device used within the body, not to test samples from the body.
The provided information clearly describes a surgical implant for structural support in the spine, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
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 (TI-LS) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy 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 inplanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Product codes
MQP
Device Description
The CAPRI Corpectomy Cage System is a hollow tube structure manufactured from Ti6Al4V ELI and Co-Cr-Mo. The cages are available in a variety of footprints, with adjustable heights and lordoses to match the patient's anatomy.
Function: The system functions as a vertebral body replacement device to 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-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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, in accordance with ASTM F2077.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111294, K060416, 080568, K003043
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast Leesburg, VA 20175
Re: K142016
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: October 8, 2014 Received: October 9, 2014
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142016
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 (TI-LS) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy 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 inplanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY CAPRI Corpectomy Cage System
Submitter
K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175
Contact Person: Nancy Giezen Telephone: 703-777-3155 Date Prepared: 07/23/2014
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 SANTORINI Corpectomy Cage System (K111294) .
Additional Predicates: -
Ulrich Obelisc (K060416)
-
DePuy X-Mesh (080568) ●
-
DePuy Surgical Titanium Mesh (K003043) ●
Device Description
The CAPRI Corpectomy Cage System is a hollow tube structure manufactured from Ti6Al4V ELI and Co-Cr-Mo. The cages are available in a variety of footprints, with adjustable heights and lordoses to match the patient's anatomy.
- Function: The system functions as a vertebral body replacement device to 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-L5) to replace collapsed, or unstable vertebral bodies due to tumor or trauma (ie. Fracture). The CAPRI Corpectomy 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.
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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, in accordance with ASTM F2077.
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.