AccuFit Lateral Plate System

K162211 · Precision Spine, Inc. · KWQ · Nov 28, 2016 · Orthopedic

Device Facts

• Record ID: K162211
• Device Name: AccuFit Lateral Plate System
• Applicant: Precision Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Device Story

AccuFit Lateral Plate System consists of rigid titanium alloy plates and bone screws; used for temporary spinal fixation until fusion achieved. Implants attached to lateral vertebral body via lateral/anterolateral approach (T1-L5) or anterior approach (L1-S1). System includes surgical instrumentation for implantation. Provided non-sterile; requires sterilization by healthcare provider before use. Used in surgical settings by orthopedic or neurosurgeons to stabilize spine instability; provides mechanical support to facilitate fusion.

Clinical Evidence

Bench testing only. Performance evaluated via static axial compression, static torsion, and dynamic axial compression testing per ASTM F1717 standards.

Technological Characteristics

Material: Titanium alloy (Ti6Al4V ELI per ASTM F136). Components: Rigid plates and bone screws. Sterilization: Non-sterile, requires sterilization. Mechanical testing: ASTM F1717 (static/dynamic compression, torsion).

Indications for Use

Indicated for patients requiring spinal stabilization in the thoracic, thoracolumbar, lumbar, or lumbosacral spine (T1-S1) due to fracture, tumor, degenerative disc disease, scoliosis, lordosis, spinal stenosis, or failed previous surgery.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Black/Red Diamond Rattlesnake Lumbar Plating System (K133194)
• Anterior Lumbar Plate System (K070922)
• Thoracolumbar Spine Locking Plate (TSLP) System (K020244)

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 28, 2016

Precision Spine, Inc. % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K162211

Trade/Device Name: AccuFit™ Lateral Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 19, 2016 Received: October 20, 2016

Dear Mr. Maxwell:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/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,

# 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 Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

## 510(k) Number (if known)

K162211

Device Name

AccuFit™ Lateral Plate System

Indications for Use (Describe)

The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------|---------------------------------------------|
| <b>Prescription Use (Part 21 CFR 801 Subpart D)</b> | Over-The-Counter Use (21 CFR 801 Subpart C) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY | |

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

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| | 510(K) SUMMARY |
|--|----------------|
|--|----------------|

| Submitter's Name: | Precision Spine |
|----------------------------|---------------------------------------------------------------|
| Submitter's Address: | 2050 Executive Drive<br>Pearl, MS 39208 |
| Submitter's Telephone: | 973.455.7150 |
| Contact Person: | Kenneth C. Maxwell II<br>Empirical Consulting<br>719.291.6874 |
| Date Summary was Prepared: | 23 November 2016 |
| Trade or Proprietary Name: | AccuFit™ Lateral Plate System |
| Common or Usual Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Division of Orthopedic Devices |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The AccuFit Lateral Plate System consists of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) rigid plates and bones screws of varying sizes and lengths. The plate attaches by means of screws to the lateral portion of the vertebral body of the thoracolumbar spine (T1-L5). The system includes instrumentation which assists in the surgical implantation of the devices. The Lateral Plate System implants and instruments are provided non-sterile. Thev require sterilization prior to use.

### INDICATIONS FOR USE

The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

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| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|----------------|--------------------------------------------------------|---------------|------------|
| K133194 | Black/Red Diamond Rattlesnake Lumbar Plating<br>System | Eminent Spine | Primary |
| K070922 | Anterior Lumbar Plate System | Spinal USA | Additional |
| K020244 | Thoracolumbar Spine Locking Plate (TSLP) System | Synthes | Additional |

#### Table 5-1: Predicate Devices

## TECHNOLOGICAL CHARACTERISTICS

The following technological characteristics are similar between the subject and predicate devices:

- Indications for use
- Implant materials
- Principles of operation
- . Sterility

## Performance Testing Summary

The AccuFit Lateral Plate System has been tested in the following test modes:

- Static Axial Compression per ASTM F1717
- . Static Torsion per ASTM F1717
- Dynamic Axial Compression per ASTM F1717

# CONCLUSION

The subject AccuFit™ Lateral Plate System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The differences raise no new safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the AccuFit™ Lateral Plate System is substantially equivalent to the predicate devices.