MIDLINE II TI

K141942 · Centinel Spine, Inc. · OVD · Nov 7, 2014 · Orthopedic

Device Facts

• Record ID: K141942
• Device Name: MIDLINE II TI
• Applicant: Centinel Spine, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Nov 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MIDLINE II™ / MIDLINE II -Ti™ is indicated for use 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 I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The MIDLINE II™ / MIDLINE II -Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).

Device Story

Intervertebral body fusion device; stand-alone system; used for spinal fusion at L2-S1 levels. Device implanted via laparoscopic or open anterior approach; secured with provided titanium unicortical cancellous bone screws; requires no supplemental fixation. Input: autogenous bone graft (autograft only). Output: structural support for intervertebral space to facilitate fusion. Used by surgeons in clinical/OR settings. Benefits: stabilization of spinal segment in DDD patients; reduction of discogenic pain. Device modification includes addition of titanium coating and lordotic angle options.

Clinical Evidence

Bench testing only. No clinical data presented. Mechanical testing included static compression, static compression-shear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-11 and F2267-04. Coating validation included static tensile bonding, shear bonding, and Taber abrasion testing.

Technological Characteristics

Radiolucent PEEK-OPTIMA LT1 or Zeniva ZA PEEK (ASTM F2026); Tantalum X-ray markers (ASTM F560); optional plasma-sprayed commercially pure titanium coating (ASTM F1580). Titanium alloy (Ti-6Al-4V, ASTM F136) bone screws. Dimensions: 11-21mm height, 30-42mm width, 24-30.2mm length, 8°-20° lordotic angles. Sterile.

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 or retrolisthesis. Patients must have discogenic back pain confirmed by history/radiography and have failed six months of non-operative treatment. Includes patients with prior non-fusion spinal surgery at the treated level.

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

• MIDLINE (K133286)
• STALIF MIDLINE (K101301)
• Aesculap SIBD XP Spinal System (K111122)
• SpineSmith Cynch Spinal System (K102090)
• NuVasive Brigade Hyperlodotic System (K123045)
• Theken Spine VuaPOD (K101310)

Reference Devices

• STALIF C Ti (K133200)

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 7, 2014

Centinel Spine, Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H. Street Northwest, 12th Washington, District of Columbia 20005

Re: K141942

Trade/Device Name: MIDLINE IITM / MIDLINE II-TiTM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: October 8, 2014 Received: October 9, 2014

Dear Mr. Eggleton:

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. Justin Eggleton

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

510(k) Number (if known) K141942

Device Name MIDLINE IITM / MIDLINE II-TiTM

#### Indications for Use (Describe)

The MIDLINE II™ / MIDLINE II -Ti™ is indicated for use 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 I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The MIDLINE II™ / MIDLINE II -Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The MIDLINE II™ / MIDLINE II -Ti™ system must be used with bone grafting material (autograft only).

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

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# 510(k) Summary

| Device Trade Name: | MIDLINE IITM / MIDLINE II-TiTM |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Centinel Spine, Inc.<br>900 Airport Road, Suite 3B<br>West Chester, PA 19380 |
| Contact: | Mr. John Parry<br>Development Manager<br>Phone: [phone]<br>[e-mail] |
| Prepared by: | Justin Eggleton<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | October 8, 2014 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | OVD |
| Primary Predicate: | K133286 (MIDLINETM) |
| Additional Predicates: | STALIF MIDLINE™ (K101301), Aesculap SIBD XP Spinal<br>System (K111122), SpineSmith Cynch Spinal System (K102090),<br>NuVasive Brigade Hyperlodotic System (K123045), Theken Spine<br>VuaPOD (K101310) |
| Reference Device: | K133200 (STALIF C® Ti) |

### Indications For Use:

The MIDLINE III™ / MIDLINE II-Ti™ is indicated for use 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 I 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. Patients with previous non-fusion spinal surgery at the

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treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The MIDLINE II™ / MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The MIDLINE IIIM / MIDLINE II-Ti™ system must be used with bone grafting material (autograft only).

## Device Description:

The MIDLINE III™ / MIDLINE II-Ti™ is a radiolucent intervertebral body fusion device manufactured from either PEEK-OPTIMA® LT1 supplied by Invibio or Zeniva ZA PEEK supplied by Solvay per ASTM F2026 with three metallic X-ray markers manufactured from unalloyed Tantalum (ASTM F560) and plasma sprayed with optional commercially pure titanium (CPT) per ASTM F1580. The device is secured with titanium (Ti-6A1-4V per ASTM F136) unicortical cancellous bone screws provided and is intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the MIDLINE™ (K133286) to include a titanium coating (ASTM F1580-12) and an additional lordotic option.

The MIDLINE II™ / MIDLINE II-Ti™ is provided in 11-21mm heights, 30-42mm widths, 24-30.2mm lengths, and lordotic angles ranging from 8°-20°. The devices are provided sterile.

### Predicate Device:

The subject MIDLINE IIIM / MIDLINE II-Ti™ device is substantially equivalent to predicate MIDLINE™ and STALIF MIDLINE™ devices (K133286, K101301) with respect to indications, design, function, and performance.

### Substantial Equivalence:

Testing performed indicate that the MIDLINE II™ / MIDLINE II-Ti™ is as mechanically sound as predicate devices. Testing included static compression, static compressionshear, dynamic compression, dynamic torsion, dynamic compression-shear, expulsion, and subsidence per ASTM F2077-11 and F2267-04. In addition, coating validation testing was performed, including static tensile bonding, shear bonding, and Taber abrasion testing. The results demonstrate that the acceptance criteria defined by predicate device performance were met.

### Conclusion:

Centinel Spine provided sufficient information to demonstrate the MIDLINE III™ / MIDLINE II-Ti™ is substantially equivalent to predicate MIDLINE™ and STALIF MIDLINE™ devices (K133286, K101301).