SPICCA Stand-Alone Cervical Fusion Cages

K230608 · Southern Medical (Pty) , Ltd. · OVE · Aug 14, 2023 · Orthopedic

Device Facts

• Record ID: K230608
• Device Name: SPICCA Stand-Alone Cervical Fusion Cages
• Applicant: Southern Medical (Pty) , Ltd.
• Product Code: OVE · Orthopedic
• Decision Date: Aug 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Device Story

Single-use, sterile interbody fusion cages for anterior cervical discectomy and fusion (ACDF) procedures. Implanted via open anterior approach between adjacent vertebral bodies to provide structural support and facilitate fusion. Packed with autograft or allogenic bone graft. Integrated fixation provided by two screws. Available in multiple sizes and footprints; includes tantalum radiographic markers. Offered uncoated or with titanium plasma spray coating. Used by surgeons in clinical settings to treat degenerative disc disease. Benefits include stabilization of the cervical spine segment to promote fusion.

Clinical Evidence

Bench testing only. Performance evaluated via static and dynamic axial compression, compression shear, and torsion per ASTM F2077, and subsidence testing per ASTM F2267. No clinical data provided.

Technological Characteristics

Materials: PEEK (ASTM F560), Ti-6Al-4V ELI (ASTM F136) screws, Tantalum (ASTM F560) markers. Optional titanium plasma spray coating (ASTM F1580). Stand-alone interbody fusion cage with integrated screw fixation. Sterile, single-use.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (neck pain of discogenic origin) requiring spinal fusion at one or two levels from C2/C3 to C7/T1. Requires at least 6 weeks of prior 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

• Vertu® Ti-Bond Cervical Interbody System (K153352)
• SureMAX-SA™ Cervical Standalone System (K211111)
• Cervical Stand-Alone System (K212853)
• Optio-C™ Anterior Cervical System (K141500)

Submission Summary (Full Text)

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August 14, 2023

Southern Medical (Pty) Ltd % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K230608

Trade/Device Name: SPICCA Stand-Alone Cervical Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: July 19, 2023 Received: July 19, 2023

Dear Nathan Wright:

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.

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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 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 -S

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

Submission Number (if known)

K230608

Device Name

SPICCA Stand-Alone Cervical Fusion Cages

Indications for Use (Describe)

The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.

lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Submitter's Name: | Southern Medical (Pty) Ltd |
|--------------------------------|-----------------------------------------------------------------------------------------------|
| Submitter's Address: | 55 Regency Drive<br>Route 21 Corporate Park Irene,<br>Centurion, Gauteng 0178 South<br>Africa |
| Submitter's Telephone: | [phone]/4 |
| Contact Person: | Nathan Wright MS Empirical<br>Technologies<br>1-719-351-0248<br>[e-mail] |
| Date Summary was Prepared: | March 3, 2023 |
| Trade or Proprietary Name: | SPICCA Stand-Alone Cervical Fusion Cages |
| Device Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| Classification & Regulation #: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The SPICCA Stand-Alone Cervical Fusion Cages are single-use, sterile, PEEK (ASTM F560) anterior cervical interbody fusion cages with integrated Ti-6Al-4V ELI (ASTM F136) screws that are intended to be implanted between two adjacent vertebral bodies as part of single or multilevel Anterior Cervical Discectory and Fusion (ACDF) procedures. The SPICCA Stand-Alone Cervical Fusion Cages which are offered in the SPICCA-SP version and SPICCA-S2 version are offered in a variety of sizes to accommodate various patient anatomies (Note: SPICCA-S2 differ in footprint options and endplate-contacting surface shape). The cages include Tantalum (ASTM F560) radiographic markers and are offered uncoated or coated with titanium plasma spray (ASTM F1580).

#### INDICATIONS FOR USE

The SPICCA Stand-Alone Cervical Fusion Cages are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two levels from the C2/C3 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.

lmplants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws should be used to ensure adequate fixation of the implant.

#### TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

- . Principle of Operation
- Structural Support Mechanism .
- . Materials
- Sizes .
- . Indications for Use

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#### Predicate Devices

| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|-------------|------------------------------------------|-------------------------------|--------------|----------------|
| K153352 | Vertu® Ti-Bond Cervical Interbody System | Spinal Elements, Incorporated | OVE, ODP | Primary |
| K211111 | SureMAX-SA™ Cervical Standalone System | Additive Implants, Inc. | OVE | Additional |
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | OVE | Additional |
| K141500 | Optio-C™ Anterior Cervical System | Zimmer Spine, Incorporated | KWQ, OVE | Additional |

#### PERFORMANCE DATA

The SPICCA Stand-Alone Cervical Fusion Cages have been tested in the following test modes:

- Static & Dynamic Axial Compression per ASTM F2077 .
- Static & Dynamic Compression Shear per ASTM F2077 .
- Static & Dynamic Torsion per ASTM F2077 .
- Subsidence per ASTM F2267 ●

The results of this non-clinical testing show that the strength of the SPICCA Stand-Alone Cervical Fusion Cages are sufficient for the intended use and are substantially equivalent to legally marketed predicate devices.

#### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the SPICCA Stand-Alone Cervical Fusion Cages are substantially equivalent to the predicate device.