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.

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the K2M, Inc. CAPRI Corpectomy Cage System. This submission introduces a new 12x14mm cervical expandable footprint size to an already cleared system. As such, the study focuses on demonstrating the substantial equivalence of this new footprint to the predicate device, rather than proving a new device's performance against specific clinical acceptance criteria for effectiveness or safety in a clinical trial setting. The studies conducted are mechanical tests to ensure the new footprint maintains the same structural integrity and performance characteristics as the predicate.

Here's the information extracted from the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for each test, but it lists the mechanical tests performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "met" if the device demonstrates substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Pass Static Compression per ASTM F2077-18	Mechanical tests were performed.
Pass Dynamic Compression per ASTM F2077-18	Mechanical tests were performed.
Pass Static Torsion per ASTM F2077-18	Mechanical tests were performed.
Pass Dynamic Torsion per ASTM F2077-18	Mechanical tests were performed.
Pass Subsidence per ASTM F2267-04 R18	Mechanical tests were performed.
Pass Static Expulsion	Mechanical tests were performed.
(Overall) Demonstrate substantial equivalence in design, materials, and function to the predicate device	The new cervical expandable footprint has demonstrated substantial equivalence to the identified predicate based on design features, materials, feature comparisons, indications for use, and results of mechanical testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes (number of devices tested) for the mechanical tests. It also does not mention data provenance in terms of country of origin or whether a retrospective/prospective study was conducted, as these were benchtop mechanical tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of study described. The study involves mechanical testing against ASTM standards and comparison to a predicate device, not expert-based ground truth establishment as would be seen in diagnostic imaging or clinical effectiveness studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the study involves mechanical testing against defined standards, not human evaluation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a spinal implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is a medical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" is typically defined by adherence to established engineering standards (e.g., ASTM F2077-18, ASTM F2267-04 R18) and meeting performance characteristics comparable to the predicate device. There is no expert consensus, pathology, or outcomes data used as ground truth for this type of submission.

8. The sample size for the training set

This is not applicable. There is no training set mentioned, as this is a submission for a medical implant, not a machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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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.

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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

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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.

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.

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 :	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 intendedfor use in the cervical and thoracolumbar spine.
	When used in the cervical spine (C2-T1), CAPRI Static and Expandable cagesare intended for use in skeletally mature patients to replace a diseased ordamaged vertebral body caused by tumor, fracture, or osteomyelitis, or forreconstruction following corpectomy performed to achieve decompression ofthe spinal cord and neural tissues in cervical degenerative disorders. Thesecages are intended to restore integrity of the spinal column even in theabsence of fusion for a limited time period in patients with advanced stagetumors involving the cervical spine in whom life expectancy is of insufficientduration to permit achievement of fusion, with bone graft used at thesurgeon's discretion.
	When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandablecages are intended for use to replace a collapsed, damaged, or unstablevertebral body due to tumor and trauma (i.e. fracture). These are designed toprovide anterior spinal column support even in the absence of fusion for aprolonged period.
	The interior of the cages can be packed with autograft or allogenic bone graftcomprising cancellous and/or corticocancellous bone graft as an adjunct tofusion.
	When used in the thoracolumbar spine, the CAPRI Static and ExpandableCorpectomy cages are intended to be used with supplemental internalfixation appropriate for the implanted level, including K2M Pedicle Screw andHook Systems, and K2M Spinal Plate Systems.
	When used in the cervical spine at one or two levels, the CAPRI Static andExpandable cages are intended to be used with supplemental fixation clearedby the FDA for use in the cervical spine. When used at more than two levels,supplemental fixation should include posterior fixation which is cleared bythe FDA.
Summary of theTechnologicalCharacteristics	The subject device (a new expandable footprint in the CAPRI CorpectomyCage System) shares the same materials, fundamental scientifictechnologies, and design characteristics as the predicate device in the CAPRICorpectomy Cage System. The purpose of this submission is to introduce anew cervical expandable footprint size to the CAPRI Corpectomy CageSystem, 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 thePerformance 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.

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Regulation Number and Section

§ 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.