Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK

K143572 · Osteomed Implantes, Ltda · ODP · Jun 10, 2015 · Orthopedic

Device Facts

• Record ID: K143572
• Device Name: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
• Applicant: Osteomed Implantes, Ltda
• Product Code: ODP · Orthopedic
• Decision Date: Jun 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage. The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Spinal implants for stabilization of cervical and lumbar column; used in interbody fusion procedures. Implants feature surface ridges to prevent migration and graft windows to facilitate bony integration; integrated X-ray markers for visualization. Implanted by surgeons via open anterior (cervical) or posterior/transforaminal (lumbar) approaches. Used with autogenous bone graft and supplemental fixation systems to achieve fusion. Benefits include stabilization of spinal segments in patients with degenerative disc disease.

Clinical Evidence

No clinical studies were performed. Evidence is based on non-clinical bench testing including static and dynamic compression (ASTM F2077), static and dynamic torsion (ASTM F2077), and subsidence testing (ASTM F2267).

Technological Characteristics

Materials: Invibio® PEEK Optima LT1 (ASTM F2026) and Titanium alloy (ASTM F136). Form factor: Intervertebral cages with surface ridges and graft windows. Integrated X-ray markers. Mechanical testing per ASTM F2077 and F2267.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) requiring spinal fusion. Cervical: one level (C2-T1) for discogenic neck pain; requires 6 weeks non-operative treatment. Lumbar: one or two contiguous levels (L2-S1) for discogenic back pain, including up to Grade I spondylolisthesis; requires 6 months non-operative treatment. Must be used with autogenous bone graft and supplemental fixation.

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 AVS® TL PEEK Spacer (K083661)
• Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)
• Spinal Elements, Crystal Cervical/Lucent Straight Interbody Cages (K071724/K073351/K081968)
• LDR Spine Cervical Interbody Fusion System (K091088)
• SeaSpine, Pacifica Cage (K082310)
• DePuy, Brantigan I/F Cage (P960025)
• Surgical Dynamic, Ray Threaded Lumbar Fusion Cage (P950019)
• Meditech Advisors, Talos PLIF (K090707)

Submission Summary (Full Text)

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June 10, 2015

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

Osteomed Implantes, LTDA % Mr. J.D. Webb The OrthoMedix Group, Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K143572

Trade/Device Name: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: May 3, 2015 Received: June 5, 2015

Dear Mr. Webb:

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

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Page 2 - Mr. J.D. Webb

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (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 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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### Indications for Use

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

K143572

Page 1 of 1

510(k) Number (if known) K143572

#### Device Name

Intersomatic Cervical Device - DICOM PEEK, Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK

#### Indications for Use (Describe)

The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-TI disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.

The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-overative treatment with an intervertebral cage.

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

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

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## 510(k) Summary: DICOM PEEK and DIMEI PEEK

| Date Prepared | April 20, 2015 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Osteomed Implantes, LTDA<br>Washington Luiz Road, km 172<br>Condomínio Conpark - Rua 6, S/N<br>CEP 13501-600<br>Rio Claro - SP<br>BRAZIL<br>(19) 3532-3411 Tele |
| Contact | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 Tele<br>512-692-3699 Fax<br>e-mail: [e-mail] |
| Trade Name | Intersomatic Cervical Device - DICOM PEEK<br>Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK<br>Intersomatic Transforaminal - TLIF PEEK |
| Common Name | intervertebral body fusion device |
| Classification Name | intervertebral body fusion device - cervical<br>intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | ODP<br>MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | Stryker Spine AVS® TL PEEK Spacer (K083661) |
| Secondary Predicate<br>Devices | Zimmer, BAK/C Vista Interbody Fusion (P980048 S3)<br>Spinal Elements, Crystal Cervical/Lucent Straight Interbody Cages<br>K071724/K073351/K081968)<br>LDR Spine Cervical Interbody Fusion System (K091088)<br>SeaSpine, Pacifica Cage (K082310)<br>DePuy, Brantigan I/F Cage (P960025)<br>Surgical Dynamic, Ray Threaded Lumbar Fusion Cage (P950019)<br>Meditech Advisors, Talos PLIF (K090707) |

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| Device Description | The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral<br>Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal -<br>TLIF PEEK were developed as implants for the stabilization of the cervical and<br>lumbar spinal column. The implants have ridges on both their inferior and<br>superior surfaces to prevent migration, and graft windows which help facilitate<br>bony integration. X-ray markers are integrated for visualization of the implants<br>during and after surgery. |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Invibio® PEEK Optima LT1 (ASTM F2026)<br>Titanium alloy conforming to ASTM F136 |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral<br>Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal -<br>TLIF PEEK are substantially equivalent to the predicate devices in terms of<br>intended use, design, materials used, mechanical safety and performances. |
| Indications for Use | The Intersomatic Cervical Device - DICOM PEEK is intended for anterior<br>interbody spinal fusion procedures in skeletally mature patients with degenerative<br>disc disease (DDD) at one disc level (C2-C3 disc to the C7-T1 disc). Cervical<br>degenerative disc disease is defined as neck pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies. This<br>device is intended for use with additional supplemental fixation systems and<br>autogenous bone graft implanted via an open, anterior approach. Patients should<br>have at least six weeks of non-operative treatment prior to treatment with<br>intervertebral cage.<br><br>The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and<br>Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body<br>spinal fusion procedures in skeletally mature patients with degenerative disc<br>disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as<br>discogenic back pain with degeneration of the disc confirmed by patient history<br>and radiographic studies. These DDD patients may also have up to Grade I<br>spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to<br>be used with autogenous bone graft and implanted via an open posterior or<br>transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with<br>additional supplemental fixation. Patients should have at least six (6) months of<br>non-operative treatment prior to treatment with an intervertebral cage. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>• Static and dynamic compression per ASTM F2077<br>• Static and dynamic torsion per ASTM F2077<br>• Subsidence per ASTM F2267<br><br>The results of these evaluations indicate that the DICOM PEEK, DIMEI PEEK<br>and TLIF PEEK are equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-<br>clinical and Clinical | Osteomed Implantes considers the DICOM PEEK, DIMEI PEEK and TLIF PEEK<br>to be equivalent to the predicate devices listed above. This conclusion is based<br>upon the devices' similarities in principles of operation, technology, materials and<br>indications for use |