Px PEEK IBF System

K150500 · Innovasis, Inc. · MAX · Jun 19, 2015 · Orthopedic

Device Facts

• Record ID: K150500
• Device Name: Px PEEK IBF System
• Applicant: Innovasis, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jun 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Innovasis Px PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

Device Story

Intervertebral body fusion device; PEEK implant; used in pairs for lumbar spinal fusion (L2-S1). Implant features open cavity for autograft; convex shape; anti-migration teeth for endplate engagement. Radiolucent PEEK material; tantalum spheres for radiographic visualization. Used in hospitals/surgery centers by orthopedic surgeons via PLIF or T-PLIF approach. Requires supplemental internal spinal fixation (e.g., Innovasis Excella). Stabilizes spinal segment; promotes fusion; restricts motion; decreases pain.

Clinical Evidence

Bench testing only. Performance testing per ASTM F2077-11 and F2267-04 conducted for static axial compression, dynamic axial compression, subsidence, and expulsion. Results indicate the device performs in accordance with its intended use.

Technological Characteristics

Materials: Medical grade PEEK (Solvay Zeniva ZA-500, Evonik VESTAKEEP i4R) per ASTM F2026; Tantalum markers per ASTM F560. Design: Intervertebral body fusion cage with anti-migration teeth. Standards: ASTM F2077, F2267, F983. Sterilization: Moist heat per ISO 17665-1. Connectivity: None (mechanical implant).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD defined as discogenic back pain with degeneration confirmed by history and radiographic studies. Patients must have had at least six months of non-operative treatment. May include up to Grade 1 spondylolisthesis or retrolisthesis. Used in pairs with internal supplemental spinal fixation; interior packed with autograft.

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

• Pioneer Bullet Tip IBF (K073177)
• Jaguar IF / Brantigan Cage (P960025)

Submission Summary (Full Text)

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

June 19, 2015

Innovasis, Incorporated Mr. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K150500

Trade/Device Name: Px™ PEEK IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 19, 2015 Received: May 20, 2015

Dear Mr. McCarty:

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 – Mr. Marshall McCarty

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K150500

Page 1 of 1

510(k) Number (if known) K150500

Device Name Px™ PEEK IBF System

## Indications for Use (Describe)

The Innovasis Px™ PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.

This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px implant is intended to be packed with autograft.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is in black and features the word "INNOVASIS" in a bold, sans-serif font. Below the main wordmark are the words "INNOVATE / INVOLVE / INVENT" in a smaller font size. The logo has a modern and clean design.

# 510(k) Summary Report:

## Px™ PEEK IBF System

| Company: | Innovasis, Inc.<br>614 E. 3900 South<br>Salt Lake City, UT 84107 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Marshall C. McCarty<br>Phone: [phone]<br>[e-mail] | |
| Trade Name: | Px™ PEEK IBF System | |
| Common Name: | Intervertebral body fusion device | |
| Classification: | Regulation No.: 21CFR 888.3080<br>Class 2<br>Product Code: MAX<br>Review Panel: Orthopedic ASDB<br>Applicable Standards: | |
| | • ASTM F560-13 | Standard Specification for Unalloyed Tantalum for<br>Surgical Implant Applications |
| | • ASTM F983-86 | (Reapproved 2013) Standard Practice for<br>Permanent Marking of Orthopedic Implant<br>Components |
| | • ASTM F2026-12 | Standard Specification for Polyetheretherketone<br>(PEEK) Polymers for Surgical Implant<br>Applications |
| | • ASTM F2077-11 | Test Methods for Intervertebral Body Fusion<br>Devices |
| | • ASTM F2267-04 | (Reapproved 2011) Standard Test Method for<br>Measuring Load Induced Subsidence of<br>Intervertebral Body Fusion Device Under Static<br>Axial Compression |
| | • ISO 17665-1: 2006 | (Reapproved 2013) Sterilization of Healthcare<br>Products - Moist Heat - Part 1 Requirements for<br>the Development, Validation and Routine Control<br>of a Sterilization Process for Medical Devices |
| | The Innovasis Px™ PEEK IBF is designed for use in a posterior<br>(PLIF) approach to the lumbar spine. Manufactured by Innovasis<br>from implant grade polyetheretherketone (PEEK) conforming to<br>ASTM F2026, the Px has excellent strength, stiffness and<br>dimensional stability, with a modulus of elasticity similar to human<br>vertebral bone. The device is radiolucent allowing straightforward<br>assessment of the fusion process, while tantalum spheres are<br>located around the periphery of the device to allow implant<br>visualization during the procedure. | |
| | The single use implant devices feature an open cavity in the<br>interior geometry to accommodate bone graft and maximize bone<br>in-growth, as well as a convex shape with anti-migration teeth to<br>engage the vertebral endplates and prevent expulsion. The<br>implants are offered in a variety of different sizes to fit the<br>anatomical needs of a wide variety of patients. Reusable<br>instruments to support the PLIF surgery are provided with the<br>implants in custom sterilization trays. | |
| Performance Data: | (Non-clinical)—Performance testing per ASTM F2077-11 and<br>F2267-04 for Static Axial Compression, Dynamic Axial<br>Compression, Subsidence and Expulsion, indicates that the Px<br>PEEK IBF is capable of performing in accordance with its intended<br>use. | |
| Materials: | The implants are machined from medical grade Solvay Zeniva ZA-<br>500 and Evonik VESTAKEEP i4R polyetheretherketone per ASTM<br>F2026. The radiographic markers meet ASTM F560 for unalloyed<br>Tantalum. | |
| Intended Use: | The Innovasis Px PEEK IBF System is an intervertebral body<br>fusion device intended to stabilize a spinal segment to promote<br>fusion using bone graft, in order to restrict motion and decrease<br>pain. | |
| | Users of these products are limited to physicians trained in<br>orthopedic surgery. Clinical locations include hospitals and<br>surgery sites equipped to perform spinal surgery. | |
| Indications for Use: | The Innovasis Px™ PEEK IBF System is an intervertebral body<br>fusion device for use in patients with degenerative disc disease<br>(DDD) at one or two contiguous levels of the lumbar spine (L2-<br>S1). DDD is defined as discogenic back pain with degeneration of<br>the disc confirmed by history and radiographic studies. These | |

Primary Predicate: K073177 Pioneer Bullet Tip IBF This predicate has not been subject to a design-related recall.

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Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT".

#### Add'I Predicate: P960025 Jaguar IF / Brantigan Cage

Device Description: $Px^{TM}$ PEEK IBF System

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Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the company name in a bold, sans-serif font. The "V" in Innovasis is stylized to look like a check mark. Below the company name is the tagline "Innovate / Involve / Invent."

patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach.

This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px implant is intended to be packed with autograft.

## Basis for Substantial Equivalence:

The Px PEEK IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate device, K073177 Pioneer Surgical Technology Interbody Fusion Bullet Tip IBF and reference device P960025 Depuy Spine Jaguar IF/Brantigan Cage.

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Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe and as effective, and performs as well as or better than the legally marketed predicate device.