Renovis S141 Lumbar Interbody Cage System

K143126 · Renovis Surgical Technologies · MAX · Feb 6, 2015 · Orthopedic

Device Facts

• Record ID: K143126
• Device Name: Renovis S141 Lumbar Interbody Cage System
• Applicant: Renovis Surgical Technologies
• Product Code: MAX · Orthopedic
• Decision Date: Feb 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 Cage System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

Device Story

Renovis S141 Lumbar Interbody Cage System consists of PLIF, OLIF, and TLIF interbody fusion implants; available in PEEK or titanium alloy; various heights/lengths to accommodate patient anatomy. Implants facilitate intervertebral body fusion in lumbar spine; used with autogenous bone graft and supplemental fixation. Tantalum radiographic markers included in PEEK versions for visualization. Used in surgical setting by orthopedic or neurosurgeons. Implants provide structural support to disc space during fusion process; benefit includes stabilization of spinal segment in patients with DDD.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing per ASTM F2077 and ASTM F2267, including static and dynamic axial compression, subsidence, and expulsion testing.

Technological Characteristics

Materials: PEEK or titanium alloy; Tantalum markers (ASTM F650, ASTM F560). Designs: PLIF (lordotic), OLIF (non-lordotic), TLIF. Sterile, single-use implants. Mechanical testing per ASTM F2077 and ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis. Requires at least six months of failed non-operative treatment. Must be used with autogenous bone graft and supplemental lumbar 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

• Renovis S134 ALIF cage (K142095)
• Ray Threaded Fusion Cage (P950019)
• Lumbar I/F Cage (P960025)
• K2M Aleutian Spinal System (K133614)

Submission Summary (Full Text)

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February 6, 2015

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

Renovis Surgical Technologies % Rich Jansen, Pharm. D. President Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K143126

Trade/Device Name: Renovis S141 Lumbar Interbody Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 11, 2014 Received: November 13, 2014

Dear Dr. Jansen:

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

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Page 2 - Rich Jansen, Pharm. D.

(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 forth in the quality systems (OS) 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 yours,

# 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.

K143126

Page 1 of 1

510(k) Number (if known) K143126

Device Name

Renovis S141 Lumbar Interbody Cage System

#### Indications for Use (Describe)

The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

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

2 Prescription Use (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)

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 PRAStaff(@fda.hhs.gov

"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."

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# 510(k) SUMMARY Renovis S141 Lumbar Interbody Cage System

| Date: | January 30, 2015 |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Josh Brown<br>Renovis Surgical Technologies, Inc.<br>1901 W. Lugonia Ave, Ste 340<br>Redlands, CA 92374<br>Telephone: [phone]<br>Fax: [phone] |
| Regulatory Contact: | Rich Jansen, Pharm. D.<br>Silver Pine Consulting, LLC<br>612-281-5505 |
| Product<br>Trade Name:<br>Common Name:<br>Product Class:<br>Classification:<br>Product Code: | Renovis S141 Lumbar Interbody Cage System<br>Intervertebral Body Fusion Device<br>Class II<br>888.3080<br>MAX |

## Device Description

The Renovis S141 Lumbar Interbody Cage System consist of 3 designs and each design is available in either PEEK or titanium alloy. The PLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F650 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.

## Predicate Device

The Renovis S141 Lumbar Interbody Cage System is substantially equivalent to legally marketed predicate devices. The primary predicate is the Renovis S134 ALIF cage (K142095) Additional predicate devices are the Ray Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), and the K2M Aleutian Spinal System (K133614).

## Intended Use / Indications for Use

The Renovis S141 Lumbar Interbody Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar

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spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S141 System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S141 Cage System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.

### Performance Testing

The Renovis S141 Lumbar Interbody Cage System was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, subsidence and expulsion. Test results demonstrate that the Renovis S141 Lumbar Interbody Cage System is substantially equivalent to the predicate devices.

### Summary:

The Renovis S141 Lumbar Interbody Cage System is substantially equivalent to the predicate devices in regards to:

- . Indications for Use
- . Materials
- . Dimensions
- . Function
- Mechanical testing

The Renovis S141 Interbody Cage System demonstrates substantial equivalence to the predicate devices based on the non-clinical performance testing.