CRESCENT™ Spinal System

K171031 · Medtronic Sofamor Danek · MAX · Jul 6, 2017 · Orthopedic

Device Facts

• Record ID: K171031
• Device Name: CRESCENT™ Spinal System
• Applicant: Medtronic Sofamor Danek
• Product Code: MAX · Orthopedic
• Decision Date: Jul 6, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolishtesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Device Story

Intervertebral body fusion device; PEEK-Optima LT1 cages with tantalum markers; inserted between lumbar/lumbosacral vertebral bodies to provide support/correction during fusion. Used in open or minimally invasive posterior, transforaminal, or lateral approaches. Requires supplemental fixation instrumentation. Implants packed with autogenous bone graft. Used by surgeons in clinical/OR settings. Output is structural support for spinal fusion; aids in discogenic pain relief and spinal stabilization.

Clinical Evidence

Bench testing only. Mechanical testing (ASTM F2077) and engineering rationale used to confirm equivalence of new sizes. Biocompatibility established via predicate history. Bacterial endotoxin testing performed per ANSI/AAMI ST72 and USP <161> to confirm compliance with 20 EU/device limit.

Technological Characteristics

Materials: PEEK-Optima LT1 (implants), stainless steel (instruments), tantalum (markers). Principle: Intervertebral body fusion support. Form factor: Hollow cages of various widths/heights. Connectivity: None. Sterilization: Sterile (implants). Standards: ASTM F2077 (mechanical), ANSI/AAMI ST72 and USP <161> (endotoxin).

Indications for Use

Indicated for skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels (L2-S1), including those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment.

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

• CRESCENT™ Spinal System (K094025)
• CRESCENT™ Spinal System Titanium (K110543)
• Clydesdale Spinal System (K132897)
• Rampart-O, Rampart-T (K132053)

Submission Summary (Full Text)

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

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

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

July 6, 2017

Medtronic Sofamor Danek USA, Inc. Mr. Ankit Shah Sr. Regulatory Affairs Specialist 1800 Pvramid Place Memphis. Tennessee 38132

Re: K171031

Trade/Device Name: CRESCENT™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 6, 2017 Received: June 9, 2017

Dear Mr. Shah:

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

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

related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm. 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.

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,

# Vincent J. Devlin -S

for

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

Enclosure

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

## Indications for Use

510(k) Number (if known) K171031

Device Name CRESCENTTM Spinal System

#### Indications for Use (Describe)

The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolishtesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

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

| <div style="display:inline-block"><input checked="" type="checkbox"/></div> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block"><input type="checkbox"/></div> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### 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}------------------------------------------------

# K171031
Page 1 of 4

# CRESCENT™ Spinal System 510(k) Summary June 2017

| I. Submitter: | Medtronic Sofamor Danek USA, Inc |
|------------------------|----------------------------------------|
| | 1800 Pyramid Place |
| | Memphis, Tennessee 38132 |
| Contact: | Ankit K. Shah |
| | Sr. Regulatory Affairs Specialist |
| | Telephone: [phone] |
| | Fax: [phone] |
| Date Prepared | June 6, 2017 |
| II. Subject Device | |
| Proprietary Trade Name | CRESCENTTM Spinal System |
| Common Name | Intervertebral Body Fusion Device |
| Classification Names | Intervertebral Fusion with Bone Graft, |
| | Lumbar |
| Classification | Class II (Implants and Instruments) |
| Product Code | MAX |
| Regulation Number | 21 CFR 888.3080 |
| Predicates | CRESCENTTM Spinal System K094025 |
| | S.E. 04/26/2010, (Primary Predicate) |
| | CRESCENTTM Spinal System Titanium |
| | K110543 |
| | S.E. 08/09/2011 (Predicate 2) |
| | Clydesdale Spinal System K132897, S.E. |
| | 12/11/2013 (Predicate 3) |
| | Rampart-O, Rampart-T K132053, S.E. |
| | 09/16/2013 (Predicate 4) |

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

#### III. PRODUCT DESCRIPTION:

The CRESCENT™ Spinal System consists of PEEK cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The devices are manufactured from medical grade PEEK-Optima LT1 (polyetheretherketone) and contains tantalum markers. These devices also contain Tantalum markers used for imaging purposes.

#### IV. INDICATIONS FOR USE:

The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

## V. Comparison of Technological Characteristics

The subject CRESCENT™ Spinal System has the same indications, intended use, fundamental scientific technology and material as the previously FDA cleared predicate CRESCENT™ Spinal System K094025 (S.E. 04/26/2010) and CRESCENT™ Spinal System Titanium K110543 (S.E. 08/09/2011). The purpose of this submission is to seek clearance for the additional sizes of implant and instrument being added to the CRESECNT™ Spinal System.

{5}------------------------------------------------

#### VI. Performance Data

#### Biocompatibility

Identical to the primary predicate devices the implants in the subject Crescent™ Spinal System are provided in sterile form and are made using medical grade PEEK-Optima LT1 (polyetheretherketone) and contain Tantalum markers for imaging. The non-sterile instruments are manufactured using stainless steel and are identical to the materials used for the instruments cleared in predicate 2 CRESCENT™ Spinal System Titanium K110543 (S.E. (S.E. LT1 (polyetheretherketone) and stainless steel material used for the subject CRESCENT Spinal System implants and instruments have a long clinical history of safe and effective use in similar commercially available medical devices. Therefore, no additional biocompatibility testing is required.

#### Mechanical Testing

The predicate CRESCENT™ Spinal System K094025 (PEEK implants) are 36mm in length whereas the subject CRESCENT™ Spinal System implants are 40mm and 45mm in length maintaining the same width and height as the predicate. The ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices," defines a worst case intervertebral body fusion device with the smallest footprint and tallest height. Since we are not reducing the footprint it does not introduce a worst case. The mechanical strength and the expulsion resistance have been documented in a confirmatory engineering rationale.

Medtronic believes that the subject 40mm and 45mm longer PEEK implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device.

#### Non-Pyrogenicity Endotoxin Testing

The bacterial endotoxin test, also known as Limulus Amebocyte Lysate (LAL) test, was performed utilizing worst case subject CRESCENT™ Spinal System implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit

{6}------------------------------------------------

specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP <161>, Transfusion and Infusion Assemblies and Similar Medical Devices.

## VII. Conclusion:

An engineering rationale and risk analysis has been completed for the change. Based on the engineering rationale, risk analysis and additional supporting documentation provided in this premarket notification, Medtronic believes the subject system demonstrates substantial equivalence to listed predicate devices.