Precision Spine Interspinous Plate System

K160568 · Precision Spine, Inc. · PEK · May 4, 2016 · Orthopedic

Device Facts

• Record ID: K160568
• Device Name: Precision Spine Interspinous Plate System
• Applicant: Precision Spine, Inc.
• Product Code: PEK · Orthopedic
• Decision Date: May 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

Device Story

Precision Spine Interspinous Plate System is a posterior, non-pedicle supplemental fixation device for spinal fusion. System comprises female and male plates with integrated teeth for bone interface; optional self-drilling/self-tapping screws provide additional fixation to prevent dislocation/migration. Plates are compressed onto spinous processes. Screws feature tear-drop anti-back-out mechanism; available in fixed or variable angle configurations. Device used in surgical settings by orthopedic or neurosurgeons to stabilize spine during fusion procedures. Benefits include supplemental structural support for patients with degenerative disc disease, trauma, spondylolisthesis, or tumors. Output is mechanical stabilization of the spinous process.

Clinical Evidence

Bench testing only. Biomechanical static and dynamic testing were performed to evaluate the strength and performance of the Interspinous Plate System. Results demonstrated that the device is sufficient for its intended use and equivalent to predicate devices.

Technological Characteristics

Manufactured from medical grade Titanium (Ti 6Al-4V) per ASTM F136. System includes female and male plates (28-55mm height) and optional Ø4.0mm/Ø4.5mm screws. Features include teeth for bone interface, tear-drop anti-back-out mechanism, and variable screw angulation (4.5-degree cone). Provided non-sterile; requires sterilization. Mechanical fixation via compression.

Indications for Use

Indicated for skeletally mature patients requiring supplemental posterior non-pedicle fixation at a single level in the non-cervical spine (T1-S1) for degenerative disc disease, trauma (fracture/dislocation), spondylolisthesis, or tumor. Not for stand-alone use.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Interspinous Plate System (K151863, K142378)
• Coflex-F Implant System (K093438, K112595)

Submission Summary (Full Text)

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May 4, 2016

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

Precision Spine, Incorporated Mr. Michael C. Dawson Senior Director of Regulatory Affairs/Deputy General Counsel 2050 Executive Drive Pearl, Mississippi 39208

Re: K160568

Trade/Device Name: Precision Spine Interspinous Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: February 29, 2016 Received: February 29, 2016

Dear Mr. Dawson:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 yours,

## 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|----------------------------------------------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017<br>See PRA Statement on last page. |

**Indications for Use**

| 510(k) Number ( <i>if known</i> ) | K160568 |
|-----------------------------------|-------------------------------------------|
| Device Name | Precision Spine Interspinous Plate System |
| Indications for Use (Describe) | |

The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

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

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|

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# 5.510(K) SUMMARY

| Submitter's Name: | Precision Spine |
|----------------------------|--------------------------------------------------------------------------|
| Submitter's Address: | 2050 Executive Drive<br>Pearl, MS 39208 |
| Submitter's Telephone: | 601-420-4244 ext. 128 |
| Contact Person: | Michael C. Dawson |
| Date Summary was Prepared: | February 25, 2016 |
| Trade or Proprietary Name: | Precision Spine Interspinous Plate System |
| Common or Usual Name: | Spinous Process Plate |
| Classification: | Class II per 21 CFR §888.3050 – Spinal interlaminal<br>fixation orthosis |
| Product Code: | PEK |
| Classification Panel: | Orthopedic |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Precision Spine Interspinous Plate System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

The screws are available in multiple variations of fixed or variable angle. All lengths are provided in Ø4.0mm for primary use, or Ø4.5 mm rescue use. They have self-drilling and selftapping threads. The screws are type II anodized in varying colors depending on the length and diameter. The plate has a tear drop shaped anti-back out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation to stop implant dislocation/ migration.

### INDICATIONS FOR USE

The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

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## TECHNOLOGICAL CHARACTERISTICS

The Precision Spine Interspinous Plate System is manufactured from medical grade Titanium (Ti 6Al-4V) per ASTM F136. The implants are provided non-sterile with instructions for sterilization. The interspinous plates are designed in total heights of 28-55mm.

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

- Indications for Use ●
- Materials of manufacture ●
- . Structural support mechanism
- Sterilization ●

#### Table 5-1: Predicate Devices

| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate |
|------------------|------------------------------------|---------------------|-----------|
| K151863, K142378 | Interspinous Plate System | Precision Spine | Primary |
| K093438, K112595 | Coflex-F Implant System | Paradigm Spine, LLC | |

The subject device differs from the previously cleared version of the device in that optional screw fixation can be employed in addition to the spikes (which are unchanged) to attach the plate to the spinous process. The screws are available in fixed or variable angles in lengths of 10, 12, 14, and 16mm. All lengths are provided in Ø4.0mm diameter for primary use, or Ø4.5 mm rescue use. They have self-drilling and self-tapping threads. The screws are type II anodized in varving colors depending on the length and diameter. The plate has a tear drop shaped antiback out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation

### PERFORMANCE DATA

The Precision Spine Interspinous Plate System has been tested in the following test modes:

- Biomechanical static testing
- . Biomechanical dynamic testing

The results of this non-clinical testing show that the strength of the Interspinous Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Interspinous Plate System is substantially equivalent to the predicate device.