(227 days)
Not Found
No
The 510(k) summary describes a passive interbody fusion device made of PEEK and titanium, intended for mechanical support and facilitating fusion. There is no mention of software, algorithms, image processing, AI, ML, or any other technology that would suggest the incorporation of AI/ML. The performance studies are limited to mechanical testing.
Yes
The device is described as an interbody fusion device intended to provide mechanical support and facilitate fusion in the lumbar spine for patients with degenerative disc disease or pseudarthrosis/nonunion, addressing a medical condition.
No
The device description indicates that the Southern Transforaminal Lumbar Interbody Fusion (TLIF) family consists of implants designed to act as interbody fusion devices in the lumbar spine, providing mechanical support and facilitating fusion. There is no mention of the device performing any diagnostic functions such as detecting, monitoring, or predicting medical conditions.
No
The device description clearly states that the device consists of implants manufactured from PEEK and titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an interbody fusion device for use in the lumbar spine to facilitate fusion. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics of the implants, their materials, and how they are used in surgery (packed with bone graft, providing mechanical support). This aligns with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
The device is a surgical implant used in spinal fusion procedures.
N/A
Intended Use / Indications for Use
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion.
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 / nonunion from previous unsuccessful fusion surgery. Patients should have undergone at least six months of nonoperative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family including the PLIF Caliber Lordotic, the TLIF Bullet, and the TLIF Camber consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy. The Southern TLIF family implants are offered with straight or curved profiles. The straight profiles include the PLIF Caliber Lordotic (a PLIF) implanted from the posterior approach and the TLIF Bullet (a T-PLIF or straight TLIF) implanted from the transforaminal approach. The curved version is the TLIF Camber (a curved TLIF) implanted from the transforaminal approach.
The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Southern TLIF family implants are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The curved TLIF designs include a titanium alloy hinge (Ti-6Al-4V per ASTM F136). The Southern TLIF family implants are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L1 to S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Southern TLIF family (PLIF Caliber Lordotic and TLIF Bullet) 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
The results of this non-clinical testing show that the strength of the Southern TLIF is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K150061, K171657, K092193, K172341, K113561, K133614
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 8, 2022
Southern Medical (Pty) Ltd % Nathan Wright Engineer and Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K221182
Trade/Device Name: Southern Transforaminal Lumbar Interbody Fusion (TLIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 11, 2022 Received: November 14, 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.
1
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 medical devices and radiation-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 Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221182
Device Name
Southern Transforaminal Lumbar Interbody Fusion (TLIF)
Indications for Use (Describe)
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion.
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 / nonunion from previous unsuccessful fusion surgery. Patients should have undergone at least six months of nonoperative treatment.
Type of Use (Select one or both, as applicable) 図 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The Counter Use (21 CFR 801 Subpart C)
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3
K221182 - 510(K) SUMMARY
| Submitter's Name: | Southern Medical (Pty) Ltd |
|---|---|
| Submitter's Address: | 55 Regency Drive |
| Route 21 Corporate Park | |
| Irene, Centurion, Gauteng 0178 | |
| South Africa | |
| Submitter's Telephone: | +27 12 667 6243/4 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies Logo | |
| Date Summary was Prepared: | November 10, 2022 |
| Trade or Proprietary Name: | Southern Transforaminal Lumbar Interbody Fusion (TLIF) |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family including the PLIF Caliber Lordotic, the TLIF Bullet, and the TLIF Camber consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy. The Southern TLIF family implants are offered with straight or curved profiles. The straight profiles include the PLIF Caliber Lordotic (a PLIF) implanted from the posterior approach and the TLIF Bullet (a T-PLIF or straight TLIF) implanted from the transforaminal approach. The curved version is the TLIF Camber (a curved TLIF) implanted from the transforaminal approach.
The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. The Southern TLIF family implants are manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560. The curved TLIF designs include a titanium alloy hinge (Ti-6Al-4V per ASTM F136). The Southern TLIF family implants are provided sterile.
INDICATIONS FOR USE
The Southern Transforaminal Lumbar Interbody Fusion (TLIF) family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) are indicated for use as interbody fusion devices in the lumbar spine, auxiliary to supplementary lumbar spinal fixation systems, such as posterior pedicle screw and rod systems. The PLIF Caliber Lordotic devices are designed to be implanted bi-laterally following a posterior approach. The devices are intended to be used with autograft to facilitate fusion.
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 / nonunion from previous unsuccessful fusion surgery. Patients should have undergone at least six months of nonoperative treatment.
4
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 the same 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 or Model Name | Manufacturer | Product
Code | Predicate
Type |
|---------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------|-------------------|
| K150061 | LUCENT®, LUCENT Ti-BOND® | Spinal Elements, Inc. | MAX | Primary |
| K171657,
K092193 | ShurFit 2C Lumbar Interbody Fusion
(originally Spinal USA Intervertebral Body
Fusion Device) | Precision Spine, Inc.
(formerly Spinal USA) | MAX | Additional |
| K172341 | NuVasive® Modulus TLIF Interbody
System | NuVasive, Inc. | MAX,
PHM | Additional |
| K113561 | TM Ardis® Interbody System | Zimmer Trabecular
Metal Technology, Inc. | MAX | Additional |
| K133614 | Aleutian IBF System (Lumbar) | K2M, Inc. | MAX | Additional |
PERFORMANCE DATA
The Southern TLIF family (PLIF Caliber Lordotic and TLIF Bullet) 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
The results of this non-clinical testing show that the strength of the Southern TLIF 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 Southern TLIF family (PLIF Caliber Lordotic, TLIF Bullet, and TLIF Camber) is substantially equivalent to the predicate device.