AERO-LL LUMBAR CAGE SYSTEM

K142066 · Stryker Corporation · OVD · Nov 13, 2014 · Orthopedic

Device Facts

• Record ID: K142066
• Device Name: AERO-LL LUMBAR CAGE SYSTEM
• Applicant: Stryker Corporation
• Product Code: OVD · Orthopedic
• Decision Date: Nov 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach. The Aero™-LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.

Device Story

Aero™-LL Lumbar Cage System is an intervertebral body fusion device; hollow, bullet-shaped PEEK Optima cage with titanium alloy (Ti-6Al-4V) jacket. Features internal graft containment pockets and superior/inferior surface serrations. Optional titanium alloy fixation anchors lock into the jacket via dovetail channels. Implanted via lateral approach by surgeons; used with autogenous bone graft and supplemental spinal fixation (e.g., posterior pedicle screw/rod systems). Provides structural support to the intervertebral space to facilitate fusion; benefits patients by stabilizing the spinal segment and reducing pain associated with DDD.

Clinical Evidence

No clinical data. Evidence consists of bench testing in compliance with FDA's 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'. Mechanical testing included static and dynamic compression, compression shear, and torsion (ASTM F2077), expulsion (ASTM F04-25-02-02), subsidence (ASTM F2267), and wear debris assessment. Dynamic cadaver testing was performed to evaluate fatigue performance under multiple loading modes.

Technological Characteristics

Materials: PEEK Optima and titanium alloy (Ti-6Al-4V). Design: Hollow, bullet-shaped cage with graft windows and serrations. Fixation: Optional titanium alloy anchors with dovetail rails. Mechanical testing standards: ASTM F2077 (compression, shear, torsion), ASTM F2267 (subsidence). Implanted via lateral approach. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade I spondylolisthesis, who have failed six months of nonoperative therapy.

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

• Stryker Spine AVS PL (K082014)
• Stryker Spine Aero™-AL Lumbar Cage System (K133328)
• Stryker Spine AVS Anchor-L (K120869)
• LDR Spine Avenue L (K113285)
• Depuy Synthes SYNFIX Lateral Spacer (K131276)

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

November 13, 2014

Stryker Spine Mr. Alan Traettino Senior Director, Regulatory and Clinical Affairs 2 Pearl Court Allendale, New Jersey 07401

Re: K142066

Trade/Device Name: Aero™-LL Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: October 20, 2014 Received: October 21, 2014

Dear Mr. Traettino:

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. Alan Traettino

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" (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 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

510(k) Number (if known) K142066

Device Name Aero™-LL Lumbar Cage System

#### Indications for Use (Describe)

The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graff in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach.

The Aero™-LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.

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)

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## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Summary: AeroTM-LL Lumbar Cage System | |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
| Contact Person | Alan Traettino<br>Senior Director, Regulatory and Clinical Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | October 20, 2014 |
| Trade Name | AeroTM-LL Lumbar Cage System |
| Proposed Class | Class II |
| Classification Name<br>and Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | OVD, MAX |
| Predicate Devices | The AeroTM-LL Lumbar Cage System was shown to be<br>substantially equivalent to the devices listed below:<br>Primary Predicate Device:<br>Stryker Spine AVS <i>PL</i> (K082014)<br>Additional Predicate Devices:<br>Stryker Spine AeroTM-AL Lumbar Cage System (K133328)<br>Stryker Spine AVS Anchor-L (K120869)<br>LDR Spine Avenue L (K113285)<br>Depuy Synthes SYNFIX Lateral Spacer (K131276) |
| Device Description | The AeroTM-LL Cage is a hollow, bullet-shaped PEEK Optima<br>cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The<br>PEEK Optima cage portion consists of two closed pockets for<br>graft containment and has serrations on the superior and inferior<br>surfaces of the cage. The implant is designed to be used either<br>with or without the internal supplemental fixation provided<br>(AeroTM-LL Fixation Anchors) in addition to supplemental<br>fixation systems cleared for use in the lumbosacral spine. The<br>AeroTM-LL Fixation Anchors are constructed from titanium alloy<br>(Ti 6Al-4V) and feature rails that mate with dovetail channels<br>located within the AeroTM-LL PEEK cage. Once fully seated<br>into the channels, the anchors are designed to lock into the<br>titanium jacket. |
| Intended Use and<br>Indications for Use | The Stryker Spine AeroTM-LL is an intervertebral body fusion<br>device indicated for use with autogenous bone graft in patients<br>with degenerative disc disease (DDD) at one level or two<br>contiguous levels from L2 to S1.<br><br>DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies. The DDD patients may also have up to Grade I<br>spondylolisthesis at the involved level(s). These patients should |
| 510(k) Summary: AeroTM-LL Lumbar Cage System | |
| | be skeletally mature and have six months of nonoperative<br>therapy. |
| | The AeroTM-LL Lumbar Cage System is to be implanted via a<br>lateral approach. |
| | The AeroTM-LL Lumbar Cage System is intended to be used<br>with supplemental spinal fixation systems that have been cleared<br>for use in the lumbosacral spine (e.g., posterior pedicle screw<br>and rod systems). In addition, the device may be used with or<br>without the included fixation anchors. |
| Summary of the<br>Technological<br>Characteristics | The subject AeroTM-LL Lumbar Cage System and the predicates<br>share similar design features:<br>• Graft windows for packing autogenous bone<br>• Serrations on the superior and inferior surfaces<br>• Comparable heights, widths, depths, and lordotic angles |
| Summary of<br>Non-Clinical Testing | Testing in compliance with FDA's June 12, 2007 "Class II<br>Special Controls Guidance Document: Intervertebral Body<br>Fusion Device" was performed for the AeroTM-LL Lateral<br>Lumbar Cage System and demonstrated substantially equivalent<br>performance to the identified predicate device systems.<br>The following mechanical tests were performed:<br>• Static Compression (per ASTM F2077)<br>• Dynamic Compression (per ASTM F2077)<br>• Static Compression Shear (per ASTM F2077)<br>• Dynamic Compression Shear (per ASTM F2077)<br>• Static Torsion (per ASTM F2077)<br>• Dynamic Torsion (per ASTM F2077)<br>• Expulsion (per ASTM F04-25-02-02 Draft)<br>• Subsidence (per ASTM F2267)<br>• Wear Debris Assessment<br>• Dynamic Cadaver Testing involving the implantation of the<br>AeroTM-LL device into multiple functional spinal units and<br>subsequent evaluation of fatigue performance under multiple<br>loading modes. |
| Conclusion | Based upon a comparison of intended use, technological<br>characteristics, and device performance in the non-clinical<br>testing listed above, the AeroTM-LL Lateral Lumbar Cage<br>System has demonstrated substantial equivalence to the<br>identified predicate device systems. |

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