SAHARA Stabilization System

K190179 · K2m, Inc. · OVD · Oct 3, 2019 · Orthopedic

Device Facts

• Record ID: K190179
• Device Name: SAHARA Stabilization System
• Applicant: K2m, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Oct 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Expandable intervertebral body fusion device; provides lumbar segment support/stabilization via lateral approach. System includes lateral interbody devices and bone screws for integrated fixation. Used by surgeons in clinical settings. Implants function as adjunct to fusion; some configurations require supplemental posterior pedicle screw/rod fixation. Benefits include spinal stabilization and fusion support in degenerative conditions.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F2077 (static/dynamic compression, compression shear, torsion) and ASTM F2267 (subsidence, expulsion).

Technological Characteristics

Materials: Titanium (ASTM F67), Titanium Alloy (ASTM F136, F1472, F3001), Cobalt Chrome (ASTM F1537). Includes additively manufactured components. Expandable interbody design for lateral lumbar approach. Integrated fixation via bone screws; supplemental posterior fixation required for specific configurations.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with/without Grade 1 spondylolisthesis or retrolisthesis, or degenerative scoliosis, who have failed six months of nonoperative therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SAHARA Stabilization System (K151481)
• MOJAVE Expandable Interbody System (K171097)
• Aleutian IBF System (K133614)
• Cascadia Interbody System (K172941)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K190179

#### Device Name SAHARA Stabilization System

### Indications for Use (Describe)

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 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

## 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 [e-mail]

"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 Stryker logo at the top. Below the logo, the text "2 510(k) Summary" is displayed in a golden color. The number 2 is separated from the rest of the text. The text appears to be part of a document or presentation.

| 510(k) Summary: SAHARA Stabilization System | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | K2M, Inc. |
| Contact Person : | Name: Renee Norby<br>Phone: [phone]<br>Email: [e-mail] |
| 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)<br>Intervertebral Fusion Device with Bone Graft, Lumbar (MAX) |
| Product Code: | OVD; MAX |
| Predicate Devices: | Primary Predicate: SAHARA Stabilization System (K151481)<br><br>Additional Predicates: MOJAVE Expandable Interbody System (K171097),<br>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 the<br>previously cleared SAHARA Stabilization System. The implants function as an<br>expandable intervertebral body fusion device to provide support and<br>stabilization to the lumbar segments of the spine through a lateral approach.<br>The system includes lateral interbody devices as well as bone screws for<br>integrated fixation. The implants are manufactured from Titanium (ASTM<br>F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt<br>Chrome (ASTM F1537). The implants contain components that are additively<br>manufactured. |
| Intended Use: | The SAHARA Stabilization System implants are intervertebral body fusion<br>devices indicated for use with autograft and/or allogenic bone graft<br>comprised of cancellous and/or corticocancellous bone graft when used as an<br>adjunct to fusion in patients with degenerative disc disease (DDD) at one<br>level or two contiguous levels from L2 to S1. DDD is defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies. The DDD patients may also have up to Grade I<br>spondylolisthesis or retrolisthesis at the involved level(s). These patients<br>should be skeletally mature and have six months of nonoperative therapy.<br>Additionally, the SAHARA implants can be used as an adjunct to fusion in<br>patients diagnosed with degenerative scoliosis |
| 510(k) Summary: SAHARA Stabilization System | |
| Hyperlordotic (angles > 15°) and Lateral implants must be used with<br>supplemental fixation (i.e., posterior pedicle screw and rod system) cleared<br>for use in the lumbar spine, in addition to the bone screws provided.<br>Additional supplemental fixation (i.e. pedicle screw and rod system) is<br>needed when used as an adjunct to fusion for degenerative scoliosis.<br>Otherwise, the Sahara Stabilization System implants may be used as a stand-<br>alone device, which is intended to be used with the bone screws provided. | |
| Summary of the<br>Technological<br>Characteristics | The subject SAHARA Lateral Expandable Interbody System and the<br>predicate was shown to be substantially equivalent based on material,<br>design, and mechanical performance. |
| Summary of the<br>Performance Data | The following mechanical tests were performed:<br>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,<br>and results of mechanical testing, the SAHARA Lateral Expandable<br>Interbody System has demonstrated substantial equivalence to the<br>identified predicate devices. |

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase and black. There is a thin black line underneath the word.