The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, t) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, i) deformity (i.e., scoliosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

Device Description

The Cayman Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the spine.

The purpose of this submission is to add minimally invasive (MI) plates.

AI/ML Overview

Here's an analysis of the provided text regarding the Cayman MI Plates, focusing on the acceptance criteria and the study proving it, as requested.

Based on the provided 510(k) summary, the device in question (Cayman MI Plates) is a Class II spinal intervertebral body fixation orthosis. For such devices, the primary "acceptance criteria" and "study" proving its meeting of these criteria are typically focused on substantial equivalence to existing legally marketed predicate devices, primarily through mechanical and material testing. The regulatory pathway for this type of device (510(k)) does not typically involve traditional clinical efficacy studies with human subjects in the same way a PMA (Pre-Market Approval) device would.

Therefore, many of the requested points related to clinical trials, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in this context.

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied by 510(k) for Spinal Fixation)	Reported Device Performance (from K131533)
Material Composition	Manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards. (Implies adherence to established strength, biocompatibility, and durability for these materials, which are standard for spinal implants).
Mechanical Performance (Static Compression Bending)	Previously tested along with predicate devices. The proposed MI plates do not represent a new worst case in subsequent ASTM F1717 testing.
Mechanical Performance (Dynamic Compression Testing)	Previously tested along with predicate devices. The proposed MI plates do not represent a new worst case in subsequent ASTM F1717 testing.
Mechanical Performance (Static Torsion)	Previously tested along with predicate devices. The proposed MI plates do not represent a new worst case in subsequent ASTM F1717 testing.
Design Similarity	Similar in design to predicate plates.
Indications for Use Similarity	Similar in indications for use to predicate plates.
Safety and Effectiveness Equivalence	Expected to be equivalent in safety and effectiveness to predicate devices. (This is the overarching acceptance criterion for a 510(k); the mechanical and material data support this claim).

Study Details (Based on available 510(k) information)

Sample sizes used for the test set and the data provenance:
- The "test set" in this context refers to the mechanical testing samples (e.g., individual plates and screws) used for the engineering tests. The specific number of units tested is not provided in the summary.
- Data Provenance: The testing was conducted according to ASTM F1717 standards, which are internationally recognized American Society for Testing and Materials standards for spinal implant testing. This is a controlled laboratory setting, not human clinical data. The summary does not specify the country of origin beyond the submitter being K2M, Inc. from Leesburg, VA, USA, implying the testing was likely conducted in the US or by a contracted lab.
- Retrospective or Prospective: This is not applicable. Mechanical testing is neither retrospective nor prospective in the clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for a mechanical device like this is defined by engineering specifications and established ASTM/ISO testing standards, not expert clinical consensus on images or outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against pre-defined engineering criteria, not subjective interpretations requiring adjudication.
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. This device is a physical spinal implant, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This device is a physical spinal implant, not an AI or imaging diagnostic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the performance specifications defined by industry standards (ASTM F1717) and internal engineering requirements for spinal fixation devices. This includes criteria for material properties, fatigue life, strength, and secure fixation.
The sample size for the training set:
- This is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission.
How the ground truth for the training set was established:
- This is not applicable. See point 7.

Summary

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NOV 0 9 2013

510(k) SUMMARY Cayman MI Plates K2M, Inc.

Submitter :

K2M, Inc. 751 Miller Drive SE, Leesburg. VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155

Date Prepared: October 16, 2013

Tradename: Cayman Plate System Common Name: Thoracolumbar Plates Classification Name: Spinal intervertebral body fixation orthosis (21 CFR 888.3060) Product Code: KWQ

3. Predicate or legally marketed devices which are substantially equivalent :

K2M Cayman Plate System, K081380, K091253, K100061 .
. DePuy Aegis, K052546
DePuy M2, K972718 .
. Sofamor Danek. Z-Plate, K922543

4. Description of the device:

The Cayman Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the spine.

The purpose of this submission is to add minimally invasive (MI) plates.

5. Intended Use:

The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.

The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (TI-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LS-St ). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis. e) fracture. f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

6. Technological and Performance Characteristics:

The Cayman Thoracolumbar Plates were previously tested in static compression bending, dynamic compression testing and static torsion and were considered substantially equivalent to other legally marketed devices. Additional ASTM F1717 testing determined that the proposed MI plates do not represent a new worst case. They are similar in design, material, and indications for use to predicate plates and are expected to be equivalent in safety and effectiveness.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 9, 2013

K2M, Incorporated Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive, Southeast, Suite F1 Leesburg, Virginia 20175

Re: K131533

Trade/Device Name: Cayman Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 17, 2013 Received: October 18, 2013

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

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Page 2 - Ms. Nancy Giezen

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Erini Keith

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): K131533

Device Name: Cayman Thoracolumbar Plate System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.