The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

Device Description

The subject of this 510(k) submission is the addition of lateral implants to the previously cleared SAHARA Stabilization System. The implants function as an expandable intervertebral body fusion device to provide support and stabilization to the lumbar segments of the spine through a lateral approach. The system includes lateral interbody devices as well as bone screws for integrated fixation. The implants are manufactured from Titanium (ASTM F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt Chrome (ASTM F1537). The implants contain components that are additively manufactured.

AI/ML Overview

This document describes the SAHARA Stabilization System, an intervertebral body fusion device. The acceptance criteria and supporting study are related to the mechanical performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Static Compression per ASTM F2077	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)
Static Compression Shear per ASTM F2077	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)
Static Torsion per ASTM F2077	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)
Subsidence per ASTM F2267	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)
Expulsion	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)
Dynamic Compression per ASTM F2077	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)
Dynamic Compression Shear per ASTM F2077	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)
Dynamic Torsion per ASTM F2077	Not explicitly stated, but implies meeting or exceeding predicate device performance and safety standards.	Mechanical tests performed (implies compliance)

Note: The document only states that "mechanical tests were performed" and that the system "has demonstrated substantial equivalence to the identified predicate devices" based on material, design, and mechanical performance. It does not provide specific numerical values for the acceptance criteria or the reported performance for each test. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning the device's performance must be at least as safe and effective as the legally marketed predicate devices.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The study described is a series of mechanical tests, not a clinical study involving human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the described study involves mechanical testing, not a clinical study requiring expert assessment of ground truth.

4. Adjudication method for the test set

This information is not applicable as the described study involves mechanical testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a series of mechanical tests of an intervertebral body fusion device, not an AI-assisted diagnostic or imaging system.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through industry standards and mechanical testing protocols (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these criteria and the performance of predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set

This information is not applicable. The device is a physical implant and does not involve a training set as would be used for an AI algorithm.

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

This information is not applicable.

Summary

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October 3, 2019

K2M, Inc. % Renee Norby Regulatory Affairs Specialist Stryker Spine 2 Pearl Court Allendale, New Jersey 07401

Re: K190179

Trade/Device Name: SAHARA Stabilization System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: July 3, 2019 Received: September 3, 2019

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.

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

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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-reportingcombination-products); 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 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,

for Ronald P. Jean. PhD Director (Acting) 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) K190179

Device Name SAHARA Stabilization System

Indications for Use (Describe)

Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

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)

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510(k) Summary: SAHARA Stabilization System
Submitter:	K2M, Inc.
Contact Person :	Name: Renee NorbyPhone: 201-749-8074Email: renee.norby@stryker.com
Date Prepared:	2-October-2019
Trade Name:	SAHARA Stabilization System
Common Name:	Spinal Fixation System
Proposed Class:	Class II, 21 CFR 888.3080
Classification Name:	Intervertebral Fusion Device with Integrated Fixation, Lumbar (OVD)Intervertebral Fusion Device with Bone Graft, Lumbar (MAX)
Product Code:	OVD; MAX
Predicate Devices:	Primary Predicate: SAHARA Stabilization System (K151481)Additional Predicates: MOJAVE Expandable Interbody System (K171097),Aleutian IBF System (K133614), and Cascadia Interbody System (K172941)
Device Description:	The subject of this 510(k) submission is the addition of lateral implants to thepreviously cleared SAHARA Stabilization System. The implants function as anexpandable intervertebral body fusion device to provide support andstabilization to the lumbar segments of the spine through a lateral approach.The system includes lateral interbody devices as well as bone screws forintegrated fixation. The implants are manufactured from Titanium (ASTMF67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and CobaltChrome (ASTM F1537). The implants contain components that are additivelymanufactured.
Intended Use:	The SAHARA Stabilization System implants are intervertebral body fusiondevices indicated for use with autograft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease (DDD) at onelevel or two contiguous levels from L2 to S1. DDD is defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies. The DDD patients may also have up to Grade Ispondylolisthesis or retrolisthesis at the involved level(s). These patientsshould be skeletally mature and have six months of nonoperative therapy.Additionally, the SAHARA implants can be used as an adjunct to fusion inpatients diagnosed with degenerative scoliosis
510(k) Summary: SAHARA Stabilization System
Hyperlordotic (angles > 15°) and Lateral implants must be used withsupplemental fixation (i.e., posterior pedicle screw and rod system) clearedfor use in the lumbar spine, in addition to the bone screws provided.Additional supplemental fixation (i.e. pedicle screw and rod system) isneeded when used as an adjunct to fusion for degenerative scoliosis.Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.
Summary of theTechnologicalCharacteristics	The subject SAHARA Lateral Expandable Interbody System and thepredicate was shown to be substantially equivalent based on material,design, and mechanical performance.
Summary of thePerformance Data	The following mechanical tests were performed:Static Compression per ASTM F2077 Static Compression Shear per ASTM F2077 Static Torsion per ASTM F2077 Subsidence per ASTM F2267 Expulsion Dynamic Compression per ASTM F2077 Dynamic Compression Shear per ASTM F2077 Dynamic Torsion per ASTM F2077
Conclusion	Based on the design features, feature comparisons, indications for use,and results of mechanical testing, the SAHARA Lateral ExpandableInterbody System has demonstrated substantial equivalence to theidentified predicate devices.

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.