FORZA PTC Spacer System

K152475 · Orthofix, Inc. · MAX · Jan 14, 2016 · Orthopedic

Device Facts

• Record ID: K152475
• Device Name: FORZA PTC Spacer System
• Applicant: Orthofix, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FORZA® PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The FORZA® PTC Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC Spacer System.

Device Story

FORZA® PTC Spacer System is an intervertebral body fusion device; implanted in lumbar disc space to stabilize vertebrae, maintain disc height, and prevent vertebral collapse. Device consists of PEEK core with integrated porous Titanium alloy endplates. Not for standalone use; requires supplemental fixation (e.g., Firebird Spinal Fixation System) and bone graft (autograft/allograft). Used by surgeons in spinal fusion procedures. Provides mechanical support to facilitate fusion.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077-11 (axial compression, compression shear, torsion), ASTM F2267-04 (subsidence), and draft ASTM F04.25.02.02 (expulsion). Surface integrity testing performed per ASTM F1978, ASTM F1147, ASTM F1044, and ASTM F1877.

Technological Characteristics

Intervertebral body fusion device. Materials: PEEK core (ASTM F-2026) with integrated porous Ti-6Al-4V alloy endplates (ASTM F1580). Provided sterile. Mechanical testing per ASTM F2077, F2267. Surface testing per ASTM F1978, F1147, F1044, F1877.

Indications for Use

Indicated for skeletally mature patients with lumbar (L2-S1) degenerative disc disease (DDD) at one or two contiguous levels, including those with up to Grade I spondylolisthesis or prior non-fusion surgery. Requires 6 months of failed non-operative treatment. Must be used with autograft/allograft 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

• FORZA Spacer System (K103111)
• Endoskeleton TO/TT (K141953)
• STALIF MIDLINE II-Ti (K150643)

Reference Devices

• CONSTRUX Mini PEEK Ti Spacer System (K121649)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.

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

January 14, 2016

Orthofix Incorporated Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K152475

Trade/Device Name: FORZA® PTC Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 15, 2015 Received: December 17, 2015

Dear Ms. Volosen:

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/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

510(k) Number (if known)

K152475

Device Name FORZA® PTC Spacer System

#### Indications for Use (Describe)

The FORZA® PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA® PTC Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC Spacer System.

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

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

# FORZA® PTC Spacer System

| 510(k) Owner Information<br>Name:<br>Address: | Orthofix Inc.<br>3451 Plano Parkway<br>Lewisville, TX 75056 |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:<br>Fax Number:<br>Email: | 214-937-2145<br>214-937-3322<br>[e-mail] |
| Registration Number: | 3008524126 |
| Contact Person: | Natalia Volosen<br>Senior Regulatory Affairs Specialist |
| Date Prepared: | January 13, 2016 |
| Name of Device<br>Trade Name / Proprietary Name: | FORZA® PTC Spacer System |
| Common Name: | Intervertebral body fusion device |
| Product Code: | MAX |
| Regulatory Classification: | Class Qper 21 CFR § 888.3080 |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K103111 - FORZA Spacer System, SE 03/23/2011, Orthofix<br>(primary predicate)<br>K141953 - Endoskeleton TO/TT, SE 10/27/2014, Titan<br>Spine (additional predicate)<br>K150643 – STALIF MIDLINE II-Ti, SE 06/08/2015, Centinel<br>Spine (additional predicate)<br>Reference devices - CONSTRUX Mini PEEK Ti Spacer<br>System K121649 |
| Reason for 510(k) Submission:<br>New product offering | |

## Device Description

The ØUÜZŒ PTC Spacer System is comprised of a variety of implants that have a PEEK core as described by ASTM F-2026 with two integrated porous Titanium alloy (Ti-6Al-4V) endplates as described by ASTM F1580. The FORZA PTC Spacer System is implanted in the intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing

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adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

The ØJÜZŒ ÍRTC Spacer System is not intended to be used as a standalone device. The ØUÜZŒ PTC Spacer System must be used with a supplemental fixation system. The ØJÜZŒ PTC Spacer System implants are provided sterile.

#### Intended Use / Indications for Use

The FORZA® PTC Spacer System is indicated for spinal fusion procedures in skeletally mature patients with deqenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The FORZA® PTC Spacer System is intended for use with autograft and /or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, e.g. Firebird Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the FORZA® PTC Spacer System.

### Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the FORZA® PTC Spacer system are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.

## PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Mechanical test and analysis was performed to establish mechanical strength for FORZA® PTC Spacer system (Static and Dynamic Axial Compression Test (ASTM F2077-11), Static and Dynamic Compression Shear Test (ASTM F2077-11), Static Torsion Test (ASTM F2077-11), Subsidence Test (ASTM F2267-04) and Expulsion Test (draft ASTM F04.25.02.02). Test results demonstrated that FORZA® PTC Spacer System is substantially equivalent to the predicate FORZA Spacer System K103111.

Surface specific characterization and integrity testing were done per ASTM F1978 (Taber abrasion), ASTM F1147 (tensile testing), ASTM F1044 (coating shear strength) and ASTM F1877 (wear test).

#### Conclusion

Based upon similarities in design, materials, intended use, indications for use and the results of mechanical testing, the FORZA® PTC Spacer system is substantially equivalent to the predicate devices.