SPICCA Cervical Fusion Cages

K230607 · Southern Medical (Pty) , Ltd. · ODP · Aug 14, 2023 · Orthopedic

Device Facts

• Record ID: K230607
• Device Name: SPICCA Cervical Fusion Cages
• Applicant: Southern Medical (Pty) , Ltd.
• Product Code: ODP · Orthopedic
• Decision Date: Aug 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SPICCA Cervical Fusion Cages are cervical 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 intended to be used in combination with an anterior cervical plating system.

Device Story

SPICCA Cervical Fusion Cages are intervertebral spacers providing mechanical support to the cervical spine to facilitate arthrodesis. Implants feature various footprints, heights, and lordosis options for patient fit. Used in open, anterior cervical spinal fusion procedures; implanted by surgeons; packed with autograft or allogenic bone graft. Must be used with an anterior cervical plating system. Device provides structural stability during bone healing.

Clinical Evidence

Bench testing only. Testing included 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) with tantalum markers (ASTM F2026); optional titanium powder coating (ASTM F1580). Form factor: Interbody spacers with varying footprints, heights, and lordosis. Mechanical support via intervertebral cage design.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic neck pain confirmed by history/radiography) requiring spinal fusion at one or two levels (C2/C3 to C7/T1). Requires 6 weeks prior non-operative treatment. Contraindicated in patients without skeletal maturity or those not requiring anterior cervical plating.

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

• Crystal Spinal System (K210044)
• Tailored-C Cervical Interbody Fusion System (K200458)
• Neurostructures Cavetto® Cervical Cage System (K172320)
• SureMAX™ Family of Cervical Spacers (K193369)

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: K230607

Trade/Device Name: SPICCA Cervical Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP 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

510(k) Number (if known) K230607

Device Name SPICCA Cervical Fusion Cages

#### Indications for Use (Describe)

SPICCA Cervical Fusion Cages are cervical 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 intended to be used in combination with an anterior cervical plating system.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| <span style="padding-right: 5px;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right: 5px;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(K) SUMMARY

| Submitter's Name: | Southern Medical (Pty) Ltd |
|----------------------------|-----------------------------------------------------------------------------------------------|
| Submitter's Address: | 55 Regency Drive<br>Route 21 Corporate Park<br>Irene, Centurion, Gauteng 0178<br>South Africa |
| Submitter's Telephone: | [phone]/4 |
| Contact Person: | Nathan Wright MS<br>Empirical Technologies<br>1-719-351-0248<br>[e-mail] |
| Date Summary was Prepared: | March 3, 2023 |
| Trade or Proprietary Name: | SPICCA Cervical Fusion Cages |
| Common or Usual Name: | Interbody Fusion Device, Cervical |
| Classification: | Class II per 21 CFR §888.8030 |
| Product Code: | ODP |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The SPICCA Cervical Fusion Cages system is an intervertebral spinal fusion system comprised of cervical interbody spacers which are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant includes a variety of footprints, heights, and lordosis options to optimize patient fit. All implants are manufactured from PEEK per ASTM F560 with tantalum (ASTM F2026) markers. All the implants are offered with a titanium powder coating per ASTM F1580 and some of the implants are also offered without the coating.

#### INDICATIONS FOR USE:

SPICCA Cervical Fusion Cages are cervical 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 intended to be used in combination with an anterior cervical plating system.

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## 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:

- Indications for Use
- Materials of manufacture
- Structural support mechanism ●

#### Predicate Devices

| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Product<br>Code | Predicate<br>Type |
|----------------|-----------------------------------------------|-------------------------|-----------------|-------------------|
| K210044 | Crystal Spinal System | Spinal Elements, Inc. | ODP | Primary |
| K200458 | Tailored-C Cervical Interbody Fusion System | BeSpoke Technologies | ODP | Additional |
| K172320 | Neurostructures Cavetto® Cervical Cage System | NeuroStructures, Inc. | ODP | Additional |
| K193369 | SureMAX™ Family of Cervical Spacers | Additive Implants, Inc. | ODP | Additional |

#### PERFORMANCE DATA:

The SPICCA Cervical Fusion Cages has been tested in the following test modes:

- Static axial compression per ASTM F2077
- Static compression shear per ASTM F2077 ●
- Static torsion per ASTM F2077 ●
- Subsidence per ASTM F2267 ●
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077 ●
- . Dynamic torsion per ASTM F2077

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

#### CONCLUSION:

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