(300 days)
No
The summary describes a mechanical implant (vertebral body replacement device) and its intended use, materials, and mechanical testing. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is intended to treat diseased or damaged vertebral bodies caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy for decompression of the spinal cord and neural tissues in cervical degenerative disorders. These are therapeutic interventions.
No
Explanation: The CAPRI Corpectomy Cages are described as "vertebral body replacement devices" intended to "restore integrity of the spinal column" or "provide anterior spinal column support." Their function is to provide structural stability after a corpectomy or vertebrectomy, not to diagnose a condition.
No
The device description clearly states it is a vertebral body replacement device made of titanium and cobalt chrome, which are hardware components. The submission is for a new footprint size of this physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The CAPRI Corpectomy Cages are described as "vertebral body replacement devices" and "implants." They are surgically implanted into the spine to provide structural support.
- Intended Use: The intended use is to replace diseased or damaged vertebral bodies and restore spinal column integrity. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used for treatment and structural support, not for diagnosing a condition using in vitro methods.
N/A
Intended Use / Indications for Use
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), CAPR Static and Expandable 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 corpectorny performed to achieve decompression of the spinal 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 turnors 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), 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 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 and Expandable 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.
Product codes (comma separated list FDA assigned to the subject device)
PLR, 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. Static (titanium) and expandable (titanium and cobalt chrome) cervical cages are available and are implanted via an anterior approach. The cervical implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt Chrome (per ASTM F1537). The purpose of this Traditional 510(k) submission is to introduce a new 12x14mm cervical expandable footprint size to the previously cleared CAPRI Corpectomy Cage System.
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 and thoracolumbar spine, 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 following mechanical tests were performed:
Static Compression per ASTM F2077-18 Dynamic Compression per ASTM F2077-18 Static Torsion per ASTM F2077-18 Dynamic Torsion per ASTM F2077-18 Subsidence per ASTM F2267-04 R18 Static Expulsion
Conclusion: Based on the design features, the use of established well known materials, feature comparisons, indications for use, and results of the mechanical testing, the new cervical expandable footprint of the CAPRI Corpectomy System has demonstrated substantial equivalence to the identified predicate.
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.
Stryker CAPRI Corpectomy Cage System (K180665), Zavation Medical Products LLC - Normandy VBR System (K191423)
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.
DePuy - Surgical Titanium Mesh (K003043), Stryker Spine - CAPRI Thoracolumbar (K142016), Stryker Spine - Santorini Expandable (K111294)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
February 24, 2022
K2M, Inc. Renee Norby Senior Regulatory Affairs Specialist 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K211320
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: PLR, MQP Dated: February 14, 2022 Received: February 16, 2022
Dear Renee Norby:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211320
Device Name CAPRI Corpectomy Cage System
Indications for Use (Describe)
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), CAPR Static and Expandable 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 corpectorny performed to achieve decompression of the spinal 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 turnors 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), 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 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 and Expandable 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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all connected, giving the word a solid, block-like appearance. The color of the text is black, and the background is white.
| 510(k) Summary: CAPRI Corpectomy Cage System | ||
|---|---|---|
| Submitter: | K2M, Inc. | |
| 600 Hope Pkwy SE | ||
| Leesburg, VA 20175 | ||
| Contact Person : | Name: Renee Norby | |
| Phone: 201-725-4954 | ||
| Email: renee.norby@stryker.com | ||
| Date Prepared: | April 29, 2021 | |
| Trade Name: | CAPRI Corpectomy Cage System | |
| Common Name: | Vertebral Body Replacement Device | |
| Proposed Class: | Class II | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) | |
| Product Code: | PLR, MQP | |
| Predicate Devices: | Primary Predicate: | |
| • Stryker CAPRI Corpectomy Cage System (K180665) | ||
| Additional Predicate: | ||
| • Zavation Medical Products LLC - Normandy VBR System (K191423) | ||
| Reference Predicates: | ||
| • DePuy - Surgical Titanium Mesh (K003043) | ||
| • Stryker Spine - CAPRI Thoracolumbar (K142016) | ||
| • Stryker Spine - Santorini Expandable (K111294) | ||
| 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. Static (titanium) and expandable (titanium and cobalt | ||
| chrome) cervical cages are available and are implanted via an anterior | ||
| approach. The cervical implants of the CAPRI Corpectomy Cage Systems are | ||
| manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt | ||
| Chrome (per ASTM F1537). The purpose of this Traditional 510(k) | ||
| submission is to introduce a new 12x14mm cervical expandable footprint size | ||
| to the previously cleared CAPRI Corpectomy Cage System. | ||
| Function: The system is used to provide structural stability in skeletally | ||
| mature individuals following a corpectomy or vertebrectomy. | ||
| 510(k) Summary: CAPRI Corpectomy Cage System | ||
| Intended Use: | 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 and Expandable 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), 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 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 and | ||
| Expandable 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. | ||
| Summary of the | ||
| Technological | ||
| Characteristics | The subject device (a new expandable footprint in the CAPRI Corpectomy | |
| Cage System) shares the same materials, fundamental scientific | ||
| technologies, and design characteristics as the predicate device in the CAPRI | ||
| Corpectomy Cage System. The purpose of this submission is to introduce a | ||
| new cervical expandable footprint size to the CAPRI Corpectomy Cage | ||
| System, which retains the previously FDA cleared indications/intended use | ||
| 510(k) Summary: CAPRI Corpectomy Cage System | ||
| and mode of operation as presented in the previous 510(K) submission, K180665. | ||
| Summary of the | ||
| Performance Data | The following mechanical tests were performed: | |
| Static Compression per ASTM F2077-18 Dynamic Compression per ASTM F2077-18 Static Torsion per ASTM F2077-18 Dynamic Torsion per ASTM F2077-18 Subsidence per ASTM F2267-04 R18 Static Expulsion | ||
| Conclusion | Based on the design features, the use of established well known materials, feature comparisons, indications for use, and results of the mechanical testing, the new cervical expandable footprint of the CAPRI Corpectomy System has demonstrated substantial equivalence to the identified predicate. |
4
Image /page/4/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black and the background is white. The font is modern and the letters are closely spaced.
5
Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black, and the background is white. There is a thin black line below the word.