AccuLIF TL and PL Cage

K143616 · Stryker Corporation · MAX · Mar 5, 2015 · Orthopedic

Device Facts

• Record ID: K143616
• Device Name: AccuLIF TL and PL Cage
• Applicant: Stryker Corporation
• Product Code: MAX · Orthopedic
• Decision Date: Mar 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K143616 · Mar 5, 2015	AccuLIF TL and PL Cage	Stryker Corporation	Published clinical literature	The sponsor provided a review of published clinical data for similar lumbar interbody fusion devices to demonstrate that the use of the device in patients with degenerative scoliosis does not adversely affect performance or represent a new worst-case scenario.	Literature review; Clinical outcomes; Degenerative scoliosis

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Published clinical data for lumbar interbody fusion devices; Literature review of clinical outcomes	Patients diagnosed with degenerative scoliosis	Not applicable for this study	Clinical performance and safety in degenerative scoliosis patients

Indications for Use

The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Device Story

Expandable interbody fusion cage; inserted in unexpanded state via delivery handle; expanded in-situ to required height using hydraulic cylinder/piston system; system includes disposable flexible expansion tubing and inflation syringe; device automatically locks at 1mm increments during expansion. Used in spinal surgery; operated by surgeons. Provides structural support for intervertebral fusion; facilitates bone graft placement. Benefits patients by restoring disc height and stabilizing spinal segments in DDD or degenerative scoliosis cases.

Clinical Evidence

No new clinical or bench testing performed. Substantial equivalence supported by published clinical literature for similar lumbar interbody fusion devices, demonstrating that the use of these devices for degenerative scoliosis does not adversely affect performance.

Technological Characteristics

Expandable cage; materials: Titanium alloy (Ti6Al4V ELI, ASTM F136-08), Stainless Steel (316 LVM, ASTM F138-08), Silicone Rubber (MED-4870). Hydraulic expansion mechanism with 1mm incremental locking. Sterile, single-use components.

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 I spondylolisthesis, or degenerative scoliosis. Requires six months of failed non-operative treatment. Must be used with supplemental internal spinal fixation and bone graft.

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, ACCULIF® TL and PL Cage (K143163)
• Medtronic, Capstone Spinal System (K123027)

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

March 5, 2015

Stryker Corporation Mr. Aakash Jain Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K143616

Trade/Device Name: AccuLIF® TL and PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 18, 2014 Received: December 19, 2014

Dear Mr. Jain:

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. Aakash Jain

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.

K143616

Page 1 of 1

510(k) Number (if known) K143616

Device Name AccuLIF® TL and PL Cage

## Indications for Use (Describe)

The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

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

| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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| Stryker Spine AccuLIF® TL and PL Cage 510(k) Summary | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401 |
| Contact Person | Aakash Jain<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | March 3, 2015 |
| Trade Name | AccuLIF® TL and PL Cage |
| Common Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Proposed Class | Class II |
| Additional Classification | |
| Codification | 21 CFR § 888.3080 |
| Name | Intervertebral body fusion device |
| Product Codes | MAX |
| Predicate Devices | The AccuLIF® TL and PL Cage was shown to be substantially equivalent<br>to the device listed below:<br>• Primary Predicate: Stryker Spine, ACCULIF® TL and PL Cage K143163<br>• Additional Predicate: Medtronic, Capstone Spinal System, K123027 |
| Device Description | The AccuLIF TL and PL Cage device is an expandable interbody fusion<br>cage manufactured from implant grade Titanium alloy (TI6Al4V ELI) as<br>per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and<br>Silicone Rubber (MED-4870). As with the predicate expandable AccuLIF<br>TL and PL Cage devices, the device is inserted in unexpanded state<br>with a delivery handle and expanded in-situ to the required height via 2<br>hydraulic cylinder and piston arrangements using a hydraulic system<br>comprising disposable flexible expansion tubing set and inflation<br>syringe. The device automatically locks at 1mm increments as it<br>expands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes,<br>and lordotic angles to accommodate patient anatomy.<br><br>The AccuLIF TL and PL Cage system comprises a packaged sterile<br>AccuLIF implant, an instrument tray, and a packaged sterile Tubing<br>Assembly. Within the TL or PL instrument trays are an inserter, pressure<br>syringe, slap hammer, graft insertion cannula, graft insertion pusher,<br>bone graft block, and TL or PL distractor trials. Additional instruments<br>supplement the instrument trays. |
| Indications for Use | The AccuLIF TL and PL Cages are indicated for intervertebral body<br>fusion with autograft and/or allogenic bone graft comprised of<br>cancellous and/or corticocancellous bone graft when the subject |
| | device is used as an adjunct to fusion in patients with degenerative disc<br>disease (DDD) at one level or two contiguous levels from L2 to \$1. DDD is<br>defined as back pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies. These DDD patients may<br>also have up to Grade I spondylolisthesis or retrolisthesis at the involved<br>level(s). These patients should be skeletally mature and have<br>completed six months of non-operative treatment.<br>Additionally, the AccuLIF TL and PL Cages can be used as an adjunct<br>to fusion in patients diagnosed with degenerative scoliosis. |
| | The AccuLIF TL and PL Cages are always to be used with supplemental<br>internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to<br>be used with autograft and/or allogenic bone graft comprised of<br>cancellous and/or corticocancellous bone graft when the subject<br>device is used as an adjunct to fusion. |
| Summary of | The subject AccuLIF® TL and PL Cage and the predicate devices were |
| Technological | shown to be substantially equivalent based on material, design, and |
| Characteristics | mechanical performance and indications. |
| Summary of the<br>Performance Data | Published clinical data for lumbar interbody fusion devices similar to the<br>Stryker Spine AccuLIF TL and PL devices that are the subject of this<br>submission was provided in support of this application. The published<br>clinical outcomes demonstrated that the use of the lumbar interbody<br>fusion procedures to treat patients diagnosed with degenerative<br>scoliosis above does not adversely affect performance of the system<br>and does not represent a new worst case scenario. No changes were<br>made to the existing devices; therefore, no additional implant testing<br>was required or performed. |
| Conclusion | The design features, materials used, manufacturing, and sterilization<br>methods are identical to the previously cleared ACCULIF® TL and PL<br>Cage with the exception of expanding the indications to include the<br>degenerative scoliosis. The additional indication is identical to<br>Medtronic Capstone Spinal System. Based on information provided, the<br>subject device has been determined to be substantially equivalent to<br>the predicate devices. |

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