← Product Code [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD) · K221447

# Southern Anterior Screw Fixated Cage (SASCA) (K221447)

_Southern Medical (Pty) , Ltd. · OVD · Oct 14, 2022 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K221447

## Device Facts

- **Applicant:** Southern Medical (Pty) , Ltd.
- **Product Code:** [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD.md)
- **Decision Date:** Oct 14, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3080
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required. The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.

## Device Story

The Southern Anterior Screw Fixated Cage (SASCA) is an intervertebral body fusion device designed for stand-alone anterior lumbar spinal fusion. The device consists of a cage filled with autograft and secured with integrated bone screws. It is used by surgeons in an operating room setting to stabilize the lumbar spine, support the affected segment, and facilitate fusion in patients with degenerative disc disease or pseudarthrosis. By providing structural support and immobilization, the device aims to alleviate pain and functional disorders of the spine. The device is provided in various sizes to accommodate patient anatomy.

## Clinical Evidence

Bench testing only. Performance data includes static and dynamic axial compression, static and dynamic compression shear, and subsidence testing conducted per ASTM F2077 and ASTM F2267 standards.

## Technological Characteristics

Cage manufactured from PEEK (ASTM F2026) with tantalum markers (ASTM F560); fixation screws manufactured from Ti-6Al-4V (ASTM F136). Stand-alone intervertebral body fusion device for lumbar spine. Mechanical performance validated via ASTM F2077 and ASTM F2267.

## Regulatory 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

- STALIF M FLX™ ([K173347](/device/K173347.md))
- MectaLIF Anterior Stand Alone System ([K183426](/device/K183426.md))

## Submission Summary (Full Text)

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February 10, 2023

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

Re: K221447

Trade/Device Name: Southern Anterior Screw Fixated Cage (SASCA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD

Dear Nathan Wright:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 14, 2022. Specifically, FDA is updating the associated 510(k) Summary to correct the device description. See the attached 510(k) Summary document for the corrected version.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.

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

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Image /page/1/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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

October 14, 2022

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

Re: K221447

Trade/Device Name: Southern Anterior Screw Fixated Cage (SASCA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 14, 2022 Received: September 15, 2022

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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

# Katherine D. Kavlock -S

for

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

Enclosure

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# Indications for Use

510(k) Number (if known) K221447

Device Name

Southern Anterior Screw Fixated Cage (SASCA)

#### Indications for Use (Describe)

Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required.

The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.

Type of Use (Select one or both, as applicable) � Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Submitter's Name:          | Southern Medical (Pty) Ltd                                                                         |
|----------------------------|----------------------------------------------------------------------------------------------------|
| Submitter's Address:       | Building 10, Southern Implants Office Park<br>1 Albert Road<br>Irene, Gauteng 0062<br>South Africa |
| Submitter's Telephone:     | +27 12 667 6243/4                                                                                  |
| Contact Person:            | Nathan Wright MS<br>Empirical Technologies<br>1-719-351-0248<br>nwright@empiricaltech.com          |
| Date Summary was Prepared: | May 17, 2022                                                                                       |
| Trade or Proprietary Name: | Southern Anterior Screw Fixated Cage (SASCA)                                                       |
| Common or Usual Name:      | Intervertebral Fusion Device With Integrated Fixation, Lumbar                                      |
| Classification:            | Class II per 21 CFR §888.3080                                                                      |
| Product Code:              | OVD                                                                                                |
| Classification Panel:      | Orthopedic - Spinal Devices (DHT6B)                                                                |

# K221447 - 510(K) SUMMARY

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Southern Anterior Screw Fixated Cage (SASCA) is intended to treat pain and functional disorders of the lumbar spine by supporting, stabilizing, and immobilizing the affected segment and facilitating fusion. The SASCA devices are stand-alone devices offered in a variety of sizes to accommodate individual patient anatomy. The SASCA cages are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The fixation screws are manufactured from Ti-6A1-4V per ASTM F136. Note: The subject SASCA device is also labeled in markets outside the United States as the Sasca 2 Anterior Lumbar Standalone Fusion Cage.

## INDICATIONS FOR USE

The Southern Anterior Screw Fixated Cages are indicated for use as stand-alone anterior interbody fusion devices in the lumbar spine. The devices are designed to be used with the bone screws provided and the interior cavity must be filled with autograft. Supplementary spinal fixation is not required.

The devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The devices may also be used in patients with pseudarthrosis / non-union from previous unsuccessful fusion surgery. Patients should have undergone at least six months of non-operative treatment.

## TECHNOLOGICAL CHARACTERISTICS

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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 similar between the subject and predicates:

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

#### Table 5-1 Predicate Devices

| 510k Number | Trade or Proprietary<br>or Model Name   | Manufacturer             | Product<br>Code | Predicate<br>Type |
|-------------|-----------------------------------------|--------------------------|-----------------|-------------------|
| K173347     | STALIF M FLX™                           | Centinel Spine, Inc.     | OVD             | Primary           |
| K183426     | MectaLIF Anterior<br>Stand Alone System | Medacta International SA | OVD             | Additional        |

## PERFORMANCE DATA

The SASCA has been tested in the following test modes:

- Static and Dynamic Axial Compression per ASTM F2077 .
- Static and Dynamic Compression Shear per ASTM F2077 ●
- Subsidence per ASTM F2267 o

The results of this non-clinical testing show that the strength of the SASCA 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 SASCA is substantially equivalent to the predicate device.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K221447](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K221447)

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