FOCUS Interbody System

K221172 · Oc Medical Devices · MAX · Oct 14, 2022 · Orthopedic

Device Facts

• Record ID: K221172
• Device Name: FOCUS Interbody System
• Applicant: Oc Medical Devices
• Product Code: MAX · Orthopedic
• Decision Date: Oct 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.

Device Story

FOCUS Interbody System consists of lumbar interbody fusion implants designed as structural columns for surgical stabilization of the lumbar spine. Implants feature central cavities for bone graft packing and superior/inferior teeth to resist expulsion; lateral windows allow radiographic visualization. Available in various heights, widths, lengths, and lordotic angles to match patient anatomy. Used by surgeons in clinical settings during lumbar spinal fusion procedures; requires supplemental fixation (e.g., pedicle screw system). Implants provide structural support to the intervertebral space while facilitating fusion via autograft/allograft bone graft. Benefits include stabilization of the spinal segment, reduction of discogenic pain, and correction of spinal alignment in degenerative conditions.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic axial compression (ASTM F2077) and subsidence testing (ASTM F2267) on worst-case implants. Results demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Implants manufactured from Ti6Al4V ELI titanium alloy (ASTM F136). Optional xCELLerate coating consists of titanium powder (ASTM F1580) and calcium phosphate (ASTM F1185, ASTM F1609). Instruments made of stainless steel (ASTM F899) with Radel polymer handles. Sterile, single-use implants.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two adjacent levels from L2 to S1, presenting with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed six months of non-operative care. Also indicated as an adjunct to fusion for degenerative scoliosis. Requires use with 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

• ShurFit 2C Lumbar Interbody Fusion System (K212075)
• Cascadia™ Interbody System (K160547, K172009, K190959)

Reference Devices

• PCM® Cervical Disc System (P100012)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 14, 2022

OC Medical Devices % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026

Re: K221172

Trade/Device Name: FOCUS Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 14, 2022 Received: September 15, 2022

Dear Dr. Warden:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221172

Device Name

FOCUS Interbody System

#### Indications for Use (Describe)

The FOCUS Interbody System is intended to be used as a lumbar intervertebral fusion device at one or two adjacent levels from L2 to S1. This system should be limited to skeletally mature patients who have had six months of non-operative care for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. In addition, the FOCUS Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The FOCUS Interbody System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures such as the OrthoCircle Spine Pedicle Screw System.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| Date: | 14 September 2022 |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | OC Medical Devices |
| | 15 East Montgomery Crossroads, Suite 3 |
| | Savannah, GA 31406 |
| | 888-463-5803 |
| Sponsor Contact: | Jack Mathews, Quality/Operations Manager |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting Inc. |
| | PO Box 566 |
| | Chesterland, OH 44026 |
| | Office: 440.729.8457 |
| Proposed Trade Name: | FOCUS Interbody System |
| Common Name: | Lumbar interbody fusion device |
| Device Classification: | Class II |
| Regulation Names,<br>Regulation Numbers,<br>Product Codes: | Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX |
| Device Description: | The FOCUS Interbody System includes interbody fusion devices for lumbar<br>implantation. The FOCUS-T and FOCUS-TO implants are designed as<br>structural columns to provide surgical stabilization of the lumbar spine. Each<br>interbody has a central cavity to be packed with bone graft material and<br>inferior/superior teeth to resist expulsion. Lateral windows provide for<br>radiographic visualization on most implant sizes. The implants are available<br>with and without the XCELLerate surface coating and in a variety of height,<br>length, width and lordotic angulation combinations to accommodate the<br>patient specific anatomy and clinical circumstances. The implants are<br>supplied sterile. |
| Indications for Use: | The FOCUS Interbody System is intended to be used as a lumbar<br>intervertebral fusion device at one or two adjacent levels from L2 to S1. This<br>system should be limited to skeletally mature patients who have had six<br>months of non-operative care for the treatment of degenerative disc disease<br>(DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved<br>spinal level(s). DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies. In<br>addition, the FOCUS Interbody System can be used as an adjunct to fusion in<br>patients diagnosed with degenerative scoliosis. The FOCUS Interbody<br>System is intended for use with autograft and/or allograft comprised of<br>cancellous and/or corticocancellous bone graft and/or demineralized<br>allograft bone with bone marrow aspirate. These implants are intended for<br>use with supplemental fixation indicated for lumbar spinal fusion procedures<br>such as the OrthoCircle Spine Pedicle Screw System. |
| Materials: | The FOCUS Interbody System implants are manufactured from Ti6Al4V ELI<br>titanium alloy (ASTM F136). The xCELLerate layered coating is<br>manufactured from titanium powder (ASTM F1580) and calcium phosphate<br>(ASTM F1185 and ASTM F1609). Instruments for implantation of the device<br>are manufactured from stainless steel (under ASTM F899), some of which<br>feature Radel (polyphenylsulfone) polymer handles. |
| Primary Predicate: | ShurFit 2C Lumbar Interbody Fusion System (Precision Spine Inc. -<br>K212075) |
| Additional Predicate: | Cascadia™ Interbody System (K2M Inc. - K160547, K172009), K190959 |
| Reference Device: | PCM® Cervical Disc System (NuVasive Inc. – P100012) |
| Performance Data: | Mechanical testing of the worst case FOCUS Interbody System implant<br>included static and dynamic axial compression according to ASTM F2077<br>and subsidence according to ASTM F2267. |
| | The mechanical test results demonstrate that the FOCUS Interbody System<br>performance is substantially equivalent to the predicate devices. |
| Technological<br>Characteristics: | The FOCUS Interbody System possesses the many of the same<br>technological characteristics as the predicate devices. These include basic<br>design, material, method of stabilization, sizes and anatomic location:<br>Differences between the subject and predicate devices included the<br>substrate material (vs ShurFit 2C ) and presence of coating (vs Cascadia™)<br>but these did not raise new questions of safety and effectiveness. Therefore<br>the fundamental scientific technology of the FOCUS Interbody System<br>devices is similar to previously cleared devices. |
| Conclusion: | The FOCUS Interbody System possesses the same intended use and<br>technological characteristics as the predicate devices. Therefore the<br>FOCUS Interbody System is substantially equivalent for its intended use. |

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