A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)

K121693 · Sapphire Medical Group, Inc. · MAX · Dec 27, 2012 · Orthopedic

Device Facts

• Record ID: K121693
• Device Name: A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
• Applicant: Sapphire Medical Group, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Device Story

A-Wedge Anterior Interbody System is a lumbar intervertebral body fusion device; rounded-trapezoidal shape with central windows for bone graft; features surface teeth for stability; includes titanium alloy x-ray markers. Implanted by surgeons via anterior, lateral, or anterolateral approach to maintain disc space distraction; requires supplemental fixation. Used in clinical settings for patients with degenerative disc disease. Benefits include restoration of lumbar lordosis and sagittal balance; facilitates spinal fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed per modified ASTM F2077-03 (static/dynamic compression, static compression-shear, static torsion), ASTM F2267-04 (subsidence), and draft ASTM F04.25.02.02 (expulsion). Results met or exceeded requirements for lumbar intervertebral body fusion devices.

Technological Characteristics

Materials: Medical grade PEEK (ASTM F2026) and ELI grade titanium alloy (Ti-6Al-4V per ASTM F136) for markers. Form factor: Rounded-trapezoidal interbody cage with lordotic configurations (6° and 11°). Dimensions: 10-18mm height, 24mm depth, 26-30mm width. Single-use.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1), including those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed at least 6 months of non-operative treatment.

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

• SpineWorks A-Wedge Anterior Interbody System (K11166)

Submission Summary (Full Text)

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Sapphire Medical Group, Inc.

#### K121693

510(k) Application

#### 510(k) SUMMARY

## DEC 2 7 2012

#### Sapphire Medical Group, Inc. - A-Wedge Anterior Interbody System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness Sapphire Medical Group, Inc.'s A-Wedge Anterior Interbody System.

#### A. SUBMITTERS INFORMATION

| Submitter Name: | BioVera, LLC. |
|---------------------|-------------------------------------|
| Submitter Address: | 815 Iris Lane, Vero Beach, FL 32963 |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | [phone]; [phone] |
| Fax Number: | [phone] |
| Date of Submission: | June 1, 2012 |

#### B. DEVICE IDENTIFICATION & MANUFACTURER

| Manufacturer Name: | Sapphire Medical Group, Inc. |
|-----------------------|----------------------------------------------------------------------------------|
| Manufacturer Address: | Sapphire Medical Group, 32565 B Golden Lantern, #113<br>Dana Point, CA 92629 USA |
| Registration Number: | To be determined |
| Contact Name: | Anthony Ruggiero |
| Title: | President |
| Device Trade Name: | A-Wedge Anterior Interbody System |
| Device Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device - lumbar |
| Classification Code: | MAX - Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3080 |

#### C. PREDICATE DEVICES

K11166

SpineWorks A-Wedge Anterior Interbody System; manufactured by SpineWorks, LLC

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Sapphire Medical Group, Inc.

#### D. DEVICE DESCRIPTION

The A-Wedge Anterior Interbody System (A-Wedge AIS) was developed for the stabilization of the lumbar spinal column. The body of the device is a rounded-trapezoidal shape with two large windows allowing placement of bone graft and facilitating fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants. A-Wedge AIS implants are available in two lordotic configurations (6° and 11°) of various heights to restore lumbar lordosis and the associated sagittal balance. SMG A.I.S. implants have three titanium alloy x-ray markers. The A-Wedge AIS device is single-use only.

Materials: Medical grade PEEK (ASTM F2026) machined from Orthoplastics Vertepeek extruded bar stock (FDA master file MAF #1820). Orthoplastics Vertepeek is fabricated from Evonik Degussa medical grade Vestakeep | PEEK granules (FDA master file MAF # 1688). ELI grade titanium alloy (Ti-6Al-4V per ASTM F136) for radio opaque markers.

Function: A-Wedge AIS devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.

#### E. INTENDED USE

The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

#### F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Subject A-Wedge AIS devices are machined from medical grade extruded PEEK bar stock and fitted with radio opaque markers made from titanium alloy for visualization in radiography. The PEEK and Ti6Al4V materials are intended for permanent implantation. A-Wedge AIS devices are designed to fit the anatomic profile of the lumbar spine. Two lordosis-angle options are offered, 6 and 11 degrees. Height options range from 10 to 18mm, in 2 mm increments. One depth option is offered, 24 mm, and two width options of 26 and 30 mm.

The technological characteristics of Sapphire Medical Group, Inc.'s A-Wedge AIS devices are

June 1, 2012

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Sapphire Medical Group, Inc.

K121693

identical to the cited predicated device excepting a change in the extruded PEEK bar stock that is used to machine the subject devices. The design, instruments, sterilization, labeling, intended use, size range, and machining processes are identical for the subject device and the cited predicate device. The change in material is as follows: the subject A-Wedge AIS devices are machined from Orthoplastics Ltd. Vertepeek extruded bar and the predicate SpineWork's A-Wedge A.I.S. devices are machined from Invibio PEEK-OPTIMA extruded bar.

Mechanical testing per the FDA Guidance Document for spinal devices and the information contained in Evonik's and Orthoplastic's master files MAF # 1688 and #1820, respectively, show the change in materials for the subject A-Wedge AIS and predicate SpineWork's A-Wedge A.I.S. do not raise new types of safety and efficacy issues; therefore the subject and predicate devices are substantially equivalent.

#### G. PERFORMANCE DATA

Characterization of A-Wedge AIS devices was performed per the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" issued on June 12, 2007. Mechanical testing of the devices was performed per modified version of ASTM standard F2077-03 for static compression, dynamic compression, static compression-shear, and static torsion. Also, ASTM F2267-04 was performed to evaluate subsidence, and draft ASTM standard F04.25.02.02 was performed to evaluate expulsion. All static and dynamic test results met or exceeded the requirements for intervertebral body fusion devices intended for use in the lumbar spine.

#### H. CONCLUSION

The Sapphire Medical Group A-Wedge Anterior Interbody System is substantially equivalent to the predicate device in terms of indications for use, design, material, performance and function.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, symbolizing the department's mission to protect and promote the health and well-being of Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is in black and white.

Public Health Service

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

Letter dated: December 27, 2012

Sapphire Medical Group, Incorporated % Robert A. Poggie, PhD BioVera, LLC. 815 Iris Lane Vero Beach, Florida 32963

Re: K121693

Trade/Device Name: A-Wedge Anterior Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 19, 2012 Received: October 22, 2012

Dear Dr. Poggie:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K121693 510(k) Number (if known):

#### Device Name:

### A-Wedge Anterior Interbody System

#### Indications For Use:

The A-Wedge Anterior Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). A-Wedge Anterior Interbody System implants are to be used with autogenous bone graft and implanted via an anterior, lateral or anterolateral approach. A-Wedge Anterior Interbody System implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

AND/OR . . . . Prescription X Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

# Sarah E. Leismer

Division Sign-Off Division of Orthopedic Devices 510(k) Number: K121693

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