(54 days)
No
The 510(k) summary describes a physical implant (fusion cage) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for intervertebral body fusion procedures for degenerative disc disease to aid in spinal fixation, which is a therapeutic intervention.
No
This device is a fusion cage system used for intervertebral body fusion procedures. It is an implantable device designed to aid in spinal fixation, not to diagnose medical conditions.
No
The device description clearly states it is a "Lumbar Interbody Fusion Cage System" consisting of physical implants made from PEEK, Tantalum, and Titanium. It describes the physical characteristics and implantation procedures, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The TDM Lumbar Interbody Fusion Cage System is a surgical implant designed to be placed within the body to aid in spinal fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the TDM Lumbar Interbody Fusion Cage System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TDM Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, who have had six months of non-operative treatment. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. TDM Lumbar Interbody Fusion Cage System is to be used with supplemental fixation.
Product codes
MAX
Device Description
The TDM Lumbar Interbody Fusion Cage System (EVERGREEN PEEK PLIF Cage, LIME PEEK TLIF Cage, and PORTIA HYBRID TLIF cage) consists of intervertebral body fixation devices intended for use as an aid in spinal fixation. This system is fabricated and manufactured from PEEK as described by ASTM F2026. The Tantalum and Titanium marker used for this product is made to the voluntary standard of ASTM F560 and ASTM F136. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The EVERGREEN PEEK PLIF Cages are to be implanted via posterior approach. Two PLIF PEEK cages are placed on each side of the interbody space (right and left). The LIME PEEK TLIF Cages and PORTIA HYBRID TLIF cages are dedicated to transforaminal approach. TLIF technique involves placing only one bone graft spacer in the middle of the interbody space, without retraction of the spinal nerves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Non-clinical testing was performed to demonstrate that the subject TDM Lumbar Interbody Fusion Cage System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F2077, and ASTM F2267:
- Static Axial Compression
- Dynamic Axial Compression
- Static Torsion
- Static Shear
- Dynamic Shear
- Subsidence
The nonclinical tests demonstrate that the TDM Lumbar Interbody Fusion Cage System is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
GS Medical Co. – AnyPlus PEEK Cage (K100516), Huvexel Co. Ltd. – Galaxy PEEK Cage (K122872)
Reference Device(s)
K171808 - TDM Small Locking Plate and Screw System, K190830 - TDM Screw System
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 17, 2022
TDM Co. Ltd. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Dr Collegeville, Pennsylvania 19426
Re: K221844
Trade/Device Name: TDM Lumbar Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 15, 2022 Received: June 24, 2022
Dear Jeena Mathai:
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.
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
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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,
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) K221844
Device Name TDM Lumbar Interbody Fusion Cage System
Indications for Use (Describe)
TDM Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, who have had six months of non-operative treatment. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft. TDM Lumbar Interbody Fusion Cage System is to be used with supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
TDM's TDM Lumbar Interbody Fusion Cage System
| Sponsor: | TDM Co. Ltd. |
|---|---|
| Manufacturer | 69, Cheomdan Venture So-ro, 37 beon-gil, |
| Buk-gu, Gwangju, Korea 61003 | |
| Official Contact | Jung Wook, Choi |
| Phone: | +82-62-971-7460 |
| Fax: | +82-62-971-7461 |
| Contact Person | Jeena Mathai |
| mgsharemg@gmail.com | |
| Date: | August 12, 2022 |
| Device Name: | TDM Lumbar Interbody Fusion Cage System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device, Lumbar |
| Classification | |
| Number: | 21 CFR 888.3080 |
| Product | |
| Code/Classification: | MAX, class II |
| Description: | The TDM Lumbar Interbody Fusion Cage System (EVERGREEN PEEK PLIF |
| Cage, LIME PEEK TLIF Cage, and PORTIA HYBRID TLIF cage) consists of | |
| intervertebral body fixation devices intended for use as an aid in spinal | |
| fixation. This system is fabricated and manufactured from PEEK as | |
| described by ASTM F2026. The Tantalum and Titanium marker used for | |
| this product is made to the voluntary standard of ASTM F560 and ASTM | |
| F136. The devices are available in a variety of different sizes and heights | |
| to match more closely the patient's anatomy. The ends of the implants | |
| have machined teeth which are designed to engage with the vertebral | |
| body end plates. The EVERGREEN PEEK PLIF Cages are to be implanted | |
| via posterior approach. Two PLIF PEEK cages are placed on each side of | |
| the interbody space (right and left). The LIME PEEK TLIF Cages and | |
| PORTIA HYBRID TLIF cages are dedicated to transforaminal approach. | |
| TLIF technique involves placing only one bone graft spacer in the middle | |
| of the interbody space, without retraction of the spinal nerves. | |
| Intended Use: | TDM Lumbar Interbody Fusion Cage System is indicated for intervertebral |
| body fusion procedures in skeletally mature patients with degenerative disc | |
| disease (DDD) at one or two contiguous levels from L2-S1, who have had six | |
| months of non-operative treatment. DDD is defined as discogenic back pain | |
| with degeneration of the disc confirmed by patient history and radiographic | |
| studies. These DDD patients may also have up to Grade 1 spondylolisthesis | |
| or retrolisthesis at the involved level(s). This device is to be used with | |
| autogenous bone graft. TDM Lumbar Interbody Fusion Cage System is to be | |
| used with supplemental fixation. | |
| Performance Data: | Non-clinical testing was performed to demonstrate that the subject TDM |
| Lumbar Interbody Fusion Cage System is substantially equivalent to the | |
| predicate device. The following testing was performed in accordance | |
| with the ASTM F2077, and ASTM F2267: |
- Static Axial Compression
- Dynamic Axial Compression
- Static Torsion
- Static Shear
- Dynamic Shear
- Subsidence
The nonclinical tests demonstrate that the TDM Lumbar Interbody Fusion
Cage System is as safe, as effective, and performs as well as or better
than the legally marketed predicate devices. |
| Predicate Device: | Primary predicate: GS Medical Co. – AnyPlus PEEK Cage (K100516)
Additional predicate: Huvexel Co. Ltd. – Galaxy PEEK Cage (K122872) |
| Reference Devices: | K171808 - TDM Small Locking Plate and Screw System
K190830 - TDM Screw System |
| Technological
Characteristics | The TDM Lumbar Interbody Fusion Cage System was shown to be
substantially equivalent and has equivalent technological characteristics to
its predicate and reference devices through comparison in areas including
design, labeling/intended use, material composition, function, range of
sizes, and packaging. |
| Performance and SE
Determination: | The TDM Lumbar Interbody Fusion Cage System has been demonstrated
to be substantially equivalent to the predicate system(s) with respect to
technical characteristics, performance, and intended use. The
information provided within this premarket notification supports
substantial equivalence of the subject device to the predicate device(s). |
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