REDONDO-L

K103297 · Seaspine, Inc. · MAX · Jan 27, 2011 · Orthopedic

Device Facts

• Record ID: K103297
• Device Name: REDONDO-L
• Applicant: Seaspine, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation. When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine Spacer System is intended for use with bone graft.

Device Story

Redondo™/Redondo-L™ is an implantable spinal spacer system; manufactured from PEEK and tantalum markers; features central canals for bone graft. Used in spinal fusion (L2-S1) or vertebral body replacement (T1-L5) to restore height and biomechanical integrity. Implanted by surgeons in clinical settings. Device geometry and external 'teeth' provide fixation and prevent subluxation. Benefits include anterior decompression and stabilization of the spinal column.

Clinical Evidence

Bench testing only. Engineering and clinical rationale verification methods were used to compare subject device modifications (new cage geometry, footprint, and teeth design) against the predicate. Results confirmed that the subject device meets or exceeds the performance criteria of the predicate device.

Technological Characteristics

Materials: PEEK OPTIMA (ASTM F2026) and tantalum markers (ASTM F560). Design: Implantable spacer with central canals for bone graft; varied sizes/geometries; external teeth for fixation. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis, or for thoracolumbar (T1-L5) vertebral body replacement due to tumor or trauma/fracture.

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

• SeaSpine Spacer System (K082310)

Submission Summary (Full Text)

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

| Company Name: | SeaSpine, Inc.<br>2302 La Mirada Drive<br>Vista, CA 92081 | | | JAN 27 2011 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|-------------|
| Contact person: | Ethel Bernal<br>Regulatory Affairs Manager<br>e-mail: [e-mail]<br>Phone: [phone] Ext: 218, Fax: [phone] | | | |
| Date prepared: | November 5, 2010 | | | |
| Trade name: | Redondo™/Redondo-L™ | | | |
| Common name: | Vertebral Body Replacement Device (VBR)<br>Interbody Fusion Device (Spacer) | | | |
| Classification name: | Vertebral Body Replacement Device<br>(21 CFR 888.3060, Product Code MQP, Class II)<br>(Orthopedic Review Committee) | | | |
| | Spinal Intervertebral Body Fusion Device<br>(21 CFR 888.3080, Product Code MAX, Class II)<br>(Orthopedic Review Committee) | | | |
| Predicate Device: | Previously cleared SeaSpine Spacer System 510(k) (K082310) | | | |
| Device Description: | The SeaSpine Spacer System is a family of implantable devices (Hollywood™,<br>Pacifica™, Redondo™/Redondo-L™, Ventura™) manufactured from<br>polyetheretherketone (PEEK) and tantalum radiographic markers. The device<br>has a central canal(s) for receiving bone graft and is offered in a variety of<br>sizes and geometries to accommodate variations in pathology and patient<br>anatomy. | | | |
| Intended use: | When used as an intervertebral body fusion device, the SeaSpine Spacer<br>System is intended for spinal fusion procedures at one or two contiguous levels<br>(L2-S1) in skeletally mature patients with degenerative disc disease (DDD).<br>DDD is defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies. DDD patients may also have up<br>to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These<br>patients may have had a previous non-fusion spinal surgery at the involved<br>Page 1 of 3 | | | |

ﺴﺴ

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

spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine Spacer System is intended for use with bone graft.

Technological As was established in the submission, the subject device Redondo-L™ is Characteristics: substantially equivalent to the predicate system. Redondo-L™ devices are manufactured from PEEK OPTIMA® per ASTM F2026 with tantalum markers per ASTM F560 for radiographic visualization. The subject devices have central canals for receiving bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. These materials are identical to materials used to manufacture the predicate devices. The design characteristics are substantially equivalent to the predicate devices.

## Design Controls were used to identify any additional risks introduced by the Performance Data: subject device when compared to the predicate devices. Engineering and Clinical rationale verification methods showed no additional risks with the introduction of the subject footprints to the existing (predicate) product line. See table below for detailed verification activities.

| Device<br>Modification | Verification Method | Acceptance Criteria | Results |
|---------------------------------|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| New cage<br>geometry | Engineering<br>Rationale | Subject device has greater or equivalent<br>cross-sectional area than predicate device. | Accepted |
| | | Subject device has greater or equivalent<br>cross sectional area-to-height Ratio (A/H)<br>than the predicate device. | Accepted |
| Device<br>maximum<br>foot print | Engineering/Clinical<br>Rationale | Device length is within documented<br>vertebral body dimensions. Increase in<br>implant coverage of larger vertebral bodies<br>minimize stress on endplates and/or local<br>bone, minimizing potential implant<br>subsidence. | Accepted |

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

| Device has<br>modified,<br>external<br>"teeth" as<br>compared<br>to the<br>predicate<br>devices. | Engineering<br>Rationale | Teeth on subject device have thicker or<br>equivalent walls than predicate device to<br>provide strength and maximize fixation. | Accepted |
|--------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | | Teeth direction on subject device prevent<br>sublaxation of implant equivalently to the<br>predicate device. Since <i>in situ</i> tissue<br>around implant is mostly undisturbed with<br>the exception of the entry site, teeth avoid<br>sublaxation towards the entry site (back<br>out). | Accepted |
| Device has<br>a different<br>geometry<br>than the<br>predicate<br>devices. | Engineering<br>Rationale | Subject device has greater or equivalent<br>cross-sectional area than predicate device. | Accepted |
| | | Subject device has greater or equivalent<br>wall thickness than predicate device. | Accepted |

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Sea Spine, Inc. % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, California 92081-7862

JAN 2 7 %:1

Re: K103297

Trade/Device Name: Redondo™/Redondo-I_TM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: January 6, 2011

Received: January 7, 2011

Dear Ms. Bernal:

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

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

Page 2 – Ms. Ethel Bernal

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ahy B. n. he
for.

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

Enclosure

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

## Indications for Use Statement

510(k) Number (if known): k103297

Device Name: Redondo™/Redondo-L™

Indications for Use:

When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.

When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine Spacer System is intended for use with bone graft.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter-Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Signature)
Division of Surgical, Orthopedic,

and Restorative Devices

K103297 510(k) Number_