K2M Expandable Interbody System

K180777 · K2m, Inc. · MAX · Aug 3, 2018 · Orthopedic

Device Facts

• Record ID: K180777
• Device Name: K2M Expandable Interbody System
• Applicant: K2m, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K2M Expandable Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The K2M Expandable Interbody System is interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The K2M Expandable Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Device Story

Expandable titanium interbody implants; designed for intraoperative adjustment to match vertebral anatomy. Used in thoracic (T1-T12) and lumbar (L1-S1) spine surgery. Surgeon inserts device into intervertebral space; expands to restore disc height/alignment; packed with bone graft to facilitate fusion. Requires supplemental internal spinal fixation. Benefits include improved fit to patient anatomy; stabilization of spinal segments; promotion of fusion in degenerative conditions.

Clinical Evidence

Bench testing only. Performed static compression, static torsion, static compression shear, dynamic compression (ASTM F2077), subsidence (ASTM F2267), and expulsion testing. Bacterial endotoxin testing (LAL) conducted per ANSI/AAMI/ST72:2011.

Technological Characteristics

Expandable interbody implants; medical grade titanium alloy (ASTM F136). Features titanium endplates for vertebral engagement. Mechanical device; no software or energy source.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at 1-2 adjacent levels (T1-S1), including thoracic disc herniation, or as an adjunct for multilevel degenerative scoliosis. Requires 6 months of failed non-operative treatment. Used with autogenous/allogeneic bone graft and supplemental internal fixation.

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

• K2M MOJAVE Expandable Interbody System (K163364)
• NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System, AP Expandable XLIF System (K173025)

Submission Summary (Full Text)

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August 3, 2018

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K2M, Inc. Nancy Giezen Manager Regulatory Affairs 600 Hope Parkway SE Leesburg, Virginia 20175

Re: K180777

Trade/Device Name: K2M Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 6, 2018 Received: June 7, 2018

Dear Nancy 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. 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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Brent Showalter -S

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)

K180777

Device Name K2M Expandable Interbody System

#### Indications for Use (Describe)

The K2M Expandable Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The K2M Expandable Interbody System is interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The K2M Expandable Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

| Type of Use ( <i>Select one or both, as applicable</i> ) | | | |
|----------------------------------------------------------|--------------------------------------------------|---------------|---------------------------------------------|
| <span></span> | [X] Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary K2M Expandable Interbody System K2M, Inc.

# Submitter

K2M, Inc. 600 Hope Pkwy SE Leesburg, VA 20175 Contact Person: Nancy Giezen Telephone: [phone] Date Prepared: 3/23/2018

## Classification

Trade Name: K2M Expandable Interbody System Common Name: Intervertebral Fusion Device with Bone Graft Regulatory Class: Class II

## Classification Name(s):

Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080, Product Code: MAX, PHM)

# Predicate Device(s)

Primary Predicate:

K2M MOJAVE Expandable Interbody System (K163364)

Additional Predicates:

NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System, AP Expandable XLIF System (K173025)

# Device Description

The K2M Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F136)

# Indications for Use

The K2M Expandable Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The K2M Expandable Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc

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herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The K2M Expandable Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

#### Technological Comparison to Predicate(s)

The K2M Expandable Interbody System was compared to predicate systems and was found to be comparable to these systems in design, function, intended use, materials, and size.

## Non-clinical Performance Evaluation

The worst case K2M Expandable Interbody System implants were tested in static compression, static torsion, static compression shear and dynamic compression (per ASTM F2077), subsidence (per ASTM F2267) and expulsion and determined to be equivalent to predicate devices. In addition, bacterial endotoxin testing (BET), also known as limulus amebocyte lysate (LAL) testing, was conducted in accordance with ANSVAAMI/ST72:2011.

## Conclusion

There are no significant differences between these spacers and other devices currently being marketed which would adversely affect the use of the product. Therefore the K2M Expandable Interbody System implants are substantially equivalent to predicate devices.