InFill® Interbody Fusion Device

K172349 · Pinnacle Spine Group, LLC · MAX · Dec 14, 2017 · Orthopedic

Device Facts

• Record ID: K172349
• Device Name: InFill® Interbody Fusion Device
• Applicant: Pinnacle Spine Group, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Dec 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

Device Story

InFill® Interbody Fusion Device is a spinal implant system designed for lumbar interbody fusion. Implants are manufactured from PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced, incorporating tantalum markers for radiopacity. Devices are available in various sizes to accommodate patient anatomy. Used by orthopedic or neurosurgeons in clinical settings via open or minimally invasive anterior/lateral approaches. The device acts as a structural spacer to maintain disc space height and facilitate fusion when packed with autogenous bone graft. It requires concurrent use of FDA-cleared supplemental internal spinal fixation systems. The device provides mechanical stability to the spinal segment, potentially reducing back pain associated with discogenic degeneration.

Clinical Evidence

Bench testing only. Testing included static axial compression (ASTM F2077-14), static subsidence (ASTM F2267-04), static expulsion (ASTM F-04.25.02.02), and dynamic axial compression (ASTM F2077-14). Results demonstrate sufficient strength for intended use.

Technological Characteristics

Materials: PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced with tantalum markers. Conforms to ASTM standards. Form factor: Interbody spacer in various sizes. Energy source: None (mechanical implant). Sterilization: Provided sterile.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous lumbar levels (L2-S1). Requires six months of failed non-operative treatment. Must be used with autogenous bone graft and supplemental internal spinal 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

• InFill® V2 Lateral (K152259)
• InFill® Interbody Fusion Device (K150206)
• InFill® Interbody Fusion Device (K133721)
• EVOS Lumbar Interbody System (K150321)

Submission Summary (Full Text)

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December 14, 2017

Pinnacle Spine Group, LLC % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K172349

Trade/Device Name: InFill® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 13, 2017 Received: November 15, 2017

Dear Mr. Maxwell:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| | DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------|
| Food and Drug Administration | | Expiration Date: January 31, 2017 |
| | <b>Indications for Use</b> | See PRA Statement on last page. |
| 510(k) Number (if known) | K172349 | |
| Device Name | InFill® Interbody Fusion Device | |
| Indications for Use (Describe) | | |
| InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in<br>skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous<br>bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one<br>level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of<br>degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back<br>pain of discogenic origin with degeneration of the disc confirmed by history and radiographic<br>studies. The lumbar devices are to be used in patients who have had at least six months of non-<br>operative treatment. InFill® interbody fusion device is intended to be used with supplemental<br>internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These<br>implants may be implanted via a variety of open or minimally invasive approaches. These<br>approaches include anterior and lateral. | | |
| Type of Use (Select one or both, as applicable) | | |
| <b>Prescription Use</b> (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | |
| PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
| FOR FDA USE ONLY | | |
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | |
| | | |
| FORM FDA 3881 (9/13) | Page 1 of 2 | PSC Publishing Services [phone] EF |

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| Submitter's Name: | Pinnacle Spine Group, LLC |
|----------------------------|------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 2921 Canton St.<br>Dallas TX, 75226 |
| Submitter's Telephone: | 214.466.1428 |
| Contact Person: | Kenneth C. Maxwell II<br>Empirical Testing Corp.<br>719.291.6874<br>[e-mail] |
| Date Summary was Prepared: | 13 November 2017 |
| Trade or Proprietary Name: | InFill® Interbody Fusion Device |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 Device Classification |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |

#### 510(K) SUMMARY

#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The InFill® Interbody Fusion Device product family consists of radiolucent implantable devices manufactured from PEEK-OPTIMA® LT1 or PEEK-OPTIMA® HA Enhanced and contains tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® Interbody Fusion Device is provided sterile.

### INDICATIONS FOR USE

InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and lateral.

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### TECHNOLOGICAL CHARACTERISTICS

The InFill® V2 Lateral Device and InFill Anatomic ALIF are made from material that conforms to ASTM standards. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- Indications for use
- Implants Materials
- Structural support mechanism
- Principles of operation ●

#### Table 5-1: Predicate Devices

| 510k<br>Number | Trade or Proprietary or Model<br>Name | Manufacturer | Predicate Type |
|----------------|---------------------------------------|----------------------|----------------|
| K152259 | InFill® V2 Lateral | Pinnacle Spine Group | Primary |
| K150206 | InFill® Interbody Fusion Device | Pinnacle Spine Group | Additional |
| K133721 | InFill® Interbody Fusion Device | Pinnacle Spine Group | Additional |
| K150321 | EVOS Lumbar Interbody System | Cutting Edge Spine | Additional |

## PERFORMANCE DATA

The InFill® V2 Lateral Device (worst case device) has been tested in the following test modes:

- Static axial compression per ASTM F2077-14 .
- Static subsidence per ASTM F2267-04 ●
- Static expulsion per ASTM F-04.25.02.02 ●
- Dynamic axial compression per ASTM F2077-14 .

The results of this non-clinical testing show that the strength of the InFill® V2 Lateral Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

## CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the InFill® Interbody Fusion Device is substantially equivalent to the predicate device.