(259 days)
Not Found
No
The document describes a physical medical device (corpectomy cages) and its intended use and materials. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are based on mechanical testing and clinical literature review, not AI/ML model performance.
Yes.
These devices are intended to replace diseased or damaged vertebral bodies and provide spinal column support, which are therapeutic functions aimed at treating medical conditions.
No
The device is a vertebral body replacement device, intended for surgical implantation to provide structural stability in the spine after a corpectomy or vertebrectomy. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the SANTORINI and CAPRI Corpectomy System implants are physical vertebral body replacement devices manufactured from materials like Titanium, Cobalt Chrome, PEEK, and Tantalum. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SANTORINI and CAPRI Corpectomy Cages are described as vertebral body replacement devices intended for surgical implantation in the spine. Their function is to provide structural stability after the removal of a damaged or diseased vertebral body.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens from the patient. The device is a physical implant.
Therefore, the SANTORINI and CAPRI Corpectomy Cages fall under the category of surgical implants or medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the Santorini Corpectomy cages 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.
When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA
CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1). CAPRI Static cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes (comma separated list FDA assigned to the subject device)
PLR, MQP
Device Description
The SANTORINI and 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 and adjustable 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 (per ASTM F3001) and Cobalt Chrome (per ASTM F1537). The SANTORINI implants are made from PEEK OPTIMA LT1 (ASTM F2026) and tantalum (ASTM 560), with some components containing CP titanium (ASTM F67). The purpose of this submission is to expand the indications to include the cervical spine.
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
Cervical spine (C2-T1), Thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
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 SANTORINI and CAPRI Corpectomy Cage Systems were previously found equivalent to predicate devices when tested in static compression, static torsion, dynamic compression and dynamic torsion (per ASTM F2077) and subsidence per ASTM F2267.
Clinical data and a clinical literature review were used to support the use of the subject devices in the cervical spine. The risks of cervical use were identified and mitigated through design and surgical technique. Based on clinical literature, it was determined that the safety profile of the subject devices is equivalent to that of the predicate devices.
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.
K162315, K170055, K171704, K172032, K151651
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
§ 888.3060 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.
0
November 28, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features an abstract image of a bird. On the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health.
K2M, LLC. Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K180665
Trade/Device Name: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: November 5, 2018 Received: November 6, 2018
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. 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|---|
| Expiration Date: 06/30/2020 | Food and Drug Administration |
| See PRA Statement below. | Indications for Use |
| 510(k) Number ( if known ) | K180665 |
|---|---|
| Device Name | SANTORINI Corpectomy Cage System |
| Indications for Use (Describe) | SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine. |
When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace
a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following
corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.
These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in
patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to
permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), SANTORINI cages are intended for use to replace a collapsed, damaged,
or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal
column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or
corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the Santorini Corpectomy cages 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.
When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used
with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels,
supplemental fixation should include posterior fixation which is cleared by the FDA
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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| PSC Publishing Services (301) 4434740
| न् । ना | റു പ്രശല | (TIT) 1888 AQ-1 MAOT |
|---|---|---|
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Indications for Use (Describe) |
| | | CAPPI Coeconnymy Castomy Case System
Device Manne |
| | | SIO(k) Mundber (if known
KIBO665 |
| See PRA Statement below | Indications for Use | |
| Exp
Porth Approved: OMB No. 0910-0120 | гээлтэй иамин она НТЈАЭН 30 ТИЭМТЯАЯВО
Food and Dung Administration | |
5
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6
510(k) SUMMARY SANTORINI and CAPRI Corpectomy Cage Systems
Submitter
K2M. Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: (571) 919-2000 Date Prepared: 11/27/2018
Classification
Trade Name: SANTORINI Corpectomy Cage System, 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 PLR, MOP)
Predicate Device(s)
Primary Predicate:
-
Globus Fortfy (K162315) ●
Additional Predicates: -
K2M CAPRI Corpectomy Cage System (K170055)
-
Santorini Corpectomy Cage System (K171704)
-
Aesculap Modulift (K172032)
-
. Nuvasive X Core Mini (K151651)
Device Description
The SANTORINI and 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 and adjustable 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 (per ASTM F3001) and Cobalt Chrome (per ASTM F1537). The SANTORINI implants are made from PEEK OPTIMA LT1 (ASTM F2026) and tantalum (ASTM 560), with some components containing CP titanium (ASTM F67). The purpose of this submission is to expand the indications to include the cervical spine.
Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.
7
Intended Use
SANTORINI
SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1), SANTORINI cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used in the thoracolumbar spine (T1-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the Santorini Corpectomy cages 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.
When used in the cervical spine at one or two levels. the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA
CAPRI
CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.
When used in the cervical spine (C2-T1). CAPRI Static cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
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When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages 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.
When used in the cervical spine at one or two levels, the CAPRI Static cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA
Technological Comparison to Predicate(s)
The SANTORINI and CAPRI Corpectomy Cage Systems were 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 SANTORINI and CAPRI Corpectomy Cage Systems were previously found equivalent to predicate devices when tested in static compression, static torsion, dynamic compression and dynamic torsion (per ASTM F2077) and subsidence per ASTM F2267.
Clinical Evaluation
Clinical data and a clinical literature review were used to support the use of the subject devices in the cervical spine. The risks of cervical use were identified and mitigated through design and surgical technique. Based on clinical literature, it was determined that the safety profile of the subject devices is equivalent to that of the predicate devices.
Conclusion
There are no significant differences between the SANTORINI and CAPRI Corpectomy Cage Systems 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.