(145 days)
Not Found
No
The summary describes a physical implant (lumbar cage) made from titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are focused on mechanical properties and biocompatibility.
Yes
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease, which is a medical condition, and it is implanted to provide structural support aiding in fusion and pain relief.
No
Explanation: The TiWAVE-L™ Porous Titanium Lumbar Cage is described as an intervertebral body fusion device used for surgical treatment of degenerative disc disease, not for diagnosing conditions.
No
The device description explicitly states it is a "lumbar intervertebral body fusion device made from additive manufactured (AM) Titanium Grade 23". This is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a lumbar cage for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical implant used in vivo (within the body) to provide structural support and promote bone fusion.
- Device Description: The device is described as a physical implant made from titanium, designed to be placed between vertebrae.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). TiWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal approach or an open posterior approach. The TIWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in various heights and lengths to accommodate patients' anatomy. The 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 at one or two contiguous levels from L2-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 following tests were independently performed on the TiWAVE-L Porous Titanium Lumbar Cage to demonstrate substantial equivalence based on current industry standards:
Static and dynamic axial compression (per ASTM F2077)
Static torsion (per ASTM F2077)
Static and dynamic compression shear (per ASTM F2077)
Subsidence (per ASTM F2267)
Static Expulsion (per ASTM draft standard F04.25.02.02)
Bacterial Endotoxin (BET)
The results of these evaluations indicate that the TiWAVE-L Porous Titanium Lumbar Cage is substantially equivalent to the predicate devices.
No clinical studies were performed.
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.
NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody, HT Medical, LLC (K170318), Cascadia™ Interbody System, K2M, Inc. (K160125/ K162264/ K172009/ K172941/ K170318), BAK/L Interbody Fusion System, Zimmer (P950002), Brantigan I/F Cage, DePuy Spine, Inc. (P960025), InTess Lumbar Cage System, Kalitec Direct, LLC (K133815), InTess Cervical Cage System, Kalitec Direct, LLC (K123100)
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
January 7, 2019
Kalitec Medical, LLC % J.D. Webb Authorized Contact Person The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K182210
Trade/Device Name: TiWAVE-L™ Porous Titanium Lumbar Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 13, 2018 Received: August 15, 2018
Dear Mr. Webb:
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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Expiration Date: 06/30/2020
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
TiWAVE-L™ Porous Titanium Lumbar Cage
Indications for Use (Describe)
The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). TiWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal approach or an open posterior approach. The TIWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Y Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
for the TiWAVE
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | December 6, 2018 |
|---|---|
| Submitted by | Scott Winn |
| Kalitec Medical, LLC | |
| 618 E. South Street, Suite 500 | |
| Orlando, FL 32801 | |
| 407-545-2063 Tele | |
| 407-358-5441 Fax | |
| Primary Contact | J.D. Webb |
| OrthoMedix Group | |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Secondary Contact | Keith Cannan |
| 1890 W. CR 419, Suite 2000 | |
| Oviedo, FL 32765 | |
| 407-545-2063 Tele | |
| 407-358-5441 Fax | |
| e-mail: kcannan@kalitecmed.com | |
| Trade Name | TiWAVE-L™ Porous Titanium Lumbar Cage |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device - lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | NeoFuse™ Ti3D PLIF/TLIF/Cervical Interbody, HT Medical, LLC (K170318) |
| Additional Predicate | |
| Devices | Cascadia™ Interbody System, K2M, Inc. (K160125/ K162264/ K172009/ K172941/ |
| K170318) | |
| BAK/L Interbody Fusion System, Zimmer (P950002) | |
| Brantigan I/F Cage, DePuy Spine, Inc. (P960025) | |
| InTess Lumbar Cage System, Kalitec Direct, LLC (K133815) | |
| InTess Cervical Cage System, Kalitec Direct, LLC (K123100) | |
| Device Description | The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusion |
| devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. | |
| The implants are available in various heights and lengths to accommodate patients' | |
| anatomy. The implants are provided sterile. | |
| Materials | Implants are made from additive manufactured (AM) Titanium Grade 23 per ASTM |
| F3001. | |
| System specific instruments are made from either stainless steel conforming to ASTM | |
| F899 or Ti6Al4V ELI titanium alloy conforming to ASTM F136. | |
| Intended Use | Intervertebral body fusion devices indicated for use with autograft and/or allograft |
| comprised of cancellous and/or corticocancellous bone graft when used as an adjunct | |
| to fusion. | |
| Substantial Equivalence | |
| Claimed to Predicate | |
| Devices | The TiWAVE-L Porous Titanium Lumbar Cage is substantially equivalent to the |
| predicate devices in terms of intended use, design, materials used, mechanical safety | |
| and performances. | |
| Indications for Use | The TiWAVE-L Porous Titanium Lumbar Cage is indicated for intervertebral body |
| fusion procedures in skeletally mature patients with degenerative disc disease (DDD) | |
| of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc | |
| disease is defined as discogenic back pain with degeneration of the disc confirmed by | |
| history and radiographic studies. These DDD patients may have up to Grade 1 | |
| spondylolisthesis or retrolisthesis at the involved level(s). TiWAVE-L Porous Titanium | |
| Lumbar Cage implants are to be used with autogenous bone graft and/or allograft | |
| comprised of cancellous and/or corticocancellous bone graft implanted via a | |
| transforaminal approach or an open posterior approach. The TiWAVE-L Porous | |
| Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients | |
| should have at least (6) months of non-operative treatment prior to treatment with an | |
| intervertebral cage. Patients with previous non-fusion spinal surgery at involved level | |
| may be treated with the device | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to predicate | Intended Use |
| The TiWAVE-L Porous Titanium Lumbar Cage and all the predicates have similar | |
| intended uses. | |
| Materials | |
| The TiWAVE-L Porous Titanium Lumbar Cage is composed of the same material as | |
| the predicate device. | |
| Design Features/Functions | |
| The TiWAVE-L Porous Titanium Lumbar Cage and cited predicate devices share | |
| similar basic design features and functions. | |
| Dimensions | |
| The TiWAVE-L Porous Titanium Lumbar Cage is dimensionally similar to cited | |
| predicate devices. | |
| Sterilization | |
| The TiWAVE-L Porous Titanium Lumbar Cage is provided sterile and cited predicate | |
| devices are packaged sterile for single use only. | |
| Performance Specification | |
| Mechanical testing confirmed the TiWAVE-L Porous Titanium Lumbar Cage | |
| demonstrated equivalent performance to the cited predicate device under the same | |
| test conditions. | |
| Non-clinical Test | |
| Summary | The following tests were independently performed on the TiWAVE-L Porous |
| Titanium Lumbar Cage to demonstrate substantial equivalence based on current | |
| industry standards: |
Static and dynamic axial compression (per ASTM F2077)
Static torsion (per ASTM F2077)
Static and dynamic compression shear (per ASTM F2077)
Subsidence (per ASTM F2267)
Static Expulsion (per ASTM draft standard F04.25.02.02)
Bacterial Endotoxin (BET)
The results of these evaluations indicate that the TiWAVE-L Porous Titanium
Lumbar Cage is substantially equivalent to the predicate devices. |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions: Non-
clinical and Clinical | Kalitec Medical considers the TiWAVE-L Porous Titanium Lumbar Cage system to
be substantially equivalent to the predicate devices listed above. This conclusion is
based upon the devices' similarities in principles of operation, technology,
materials, and indications for use. Based on the testing performed, it can be
concluded that there are no new issues of safety or efficacy when comparing the
subject device to the predicates. |
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K182210
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