TDM Lumbar Interbody Fusion Cage System

K221844 · Tdm Co., Ltd. · MAX · Aug 17, 2022 · Orthopedic

Device Facts

• Record ID: K221844
• Device Name: TDM Lumbar Interbody Fusion Cage System
• Applicant: Tdm Co., Ltd.
• Product Code: MAX · Orthopedic
• Decision Date: Aug 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Intervertebral body fusion system comprising PEEK cages (EVERGREEN PLIF, LIME TLIF, PORTIA HYBRID TLIF) for spinal stabilization. Implants feature machined teeth for vertebral endplate engagement; tantalum/titanium markers for radiographic visualization. Used in lumbar spine (L2-S1) via posterior or transforaminal approach; requires autogenous bone graft and supplemental fixation. Operated by surgeons in clinical/OR settings to treat discogenic back pain. Provides structural support to facilitate fusion; benefits patients by restoring disc space height and stabilizing spinal segments.

Clinical Evidence

Bench testing only. Performed static/dynamic axial compression, static torsion, static/dynamic shear, and subsidence testing per ASTM F2077 and ASTM F2267 standards to demonstrate mechanical equivalence.

Technological Characteristics

Materials: PEEK (ASTM F2026), Tantalum (ASTM F560), Titanium (ASTM F136). Form factor: Interbody cages with machined teeth. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, with or without Grade 1 spondylolisthesis or retrolisthesis, following six months of failed non-operative treatment.

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

• GS Medical Co. – AnyPlus PEEK Cage (K100516)
• Huvexel Co. Ltd. – Galaxy PEEK Cage (K122872)

Reference Devices

• TDM Small Locking Plate and Screw System (K171808)
• TDM Screw System (K190830)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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, 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}------------------------------------------------

# 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> X </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) SUMMARY

### TDM's TDM Lumbar Interbody Fusion Cage System

| Sponsor: | TDM Co. Ltd. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | 69, Cheomdan Venture So-ro, 37 beon-gil,<br>Buk-gu, Gwangju, Korea 61003 |
| Official Contact | Jung Wook, Choi |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person | Jeena Mathai<br>[e-mail] |
| 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<br>Number: | 21 CFR 888.3080 |
| Product<br>Code/Classification: | MAX, class II |
| Description: | The TDM Lumbar Interbody Fusion Cage System (EVERGREEN PEEK PLIF<br>Cage, LIME PEEK TLIF Cage, and PORTIA HYBRID TLIF cage) consists of<br>intervertebral body fixation devices intended for use as an aid in spinal<br>fixation. This system is fabricated and manufactured from PEEK as<br>described by ASTM F2026. The Tantalum and Titanium marker used for<br>this product is made to the voluntary standard of ASTM F560 and ASTM<br>F136. The devices are available in a variety of different sizes and heights<br>to match more closely the patient's anatomy. The ends of the implants<br>have machined teeth which are designed to engage with the vertebral<br>body end plates. The EVERGREEN PEEK PLIF Cages are to be implanted<br>via posterior approach. Two PLIF PEEK cages are placed on each side of<br>the interbody space (right and left). The LIME PEEK TLIF Cages and<br>PORTIA HYBRID TLIF cages are dedicated to transforaminal approach.<br>TLIF technique involves placing only one bone graft spacer in the middle<br>of the interbody space, without retraction of the spinal nerves. |
| Intended Use: | TDM Lumbar Interbody Fusion Cage System is indicated for intervertebral<br>body fusion procedures in skeletally mature patients with degenerative disc<br>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<br>with degeneration of the disc confirmed by patient history and radiographic<br>studies. These DDD patients may also have up to Grade 1 spondylolisthesis<br>or retrolisthesis at the involved level(s). This device is to be used with<br>autogenous bone graft. TDM Lumbar Interbody Fusion Cage System is to be<br>used with supplemental fixation. |
| Performance Data: | Non-clinical testing was performed to demonstrate that the subject TDM<br>Lumbar Interbody Fusion Cage System is substantially equivalent to the<br>predicate device. The following testing was performed in accordance<br>with the ASTM F2077, and ASTM F2267:<br>- Static Axial Compression<br>- Dynamic Axial Compression<br>- Static Torsion<br>- Static Shear<br>- Dynamic Shear<br>- Subsidence<br>The nonclinical tests demonstrate that the TDM Lumbar Interbody Fusion<br>Cage System is as safe, as effective, and performs as well as or better<br>than the legally marketed predicate devices. |
| Predicate Device: | Primary predicate: GS Medical Co. – AnyPlus PEEK Cage (K100516)<br>Additional predicate: Huvexel Co. Ltd. – Galaxy PEEK Cage (K122872) |
| Reference Devices: | K171808 - TDM Small Locking Plate and Screw System<br>K190830 - TDM Screw System |
| Technological<br>Characteristics | The TDM Lumbar Interbody Fusion Cage System was shown to be<br>substantially equivalent and has equivalent technological characteristics to<br>its predicate and reference devices through comparison in areas including<br>design, labeling/intended use, material composition, function, range of<br>sizes, and packaging. |
| Performance and SE<br>Determination: | The TDM Lumbar Interbody Fusion Cage System has been demonstrated<br>to be substantially equivalent to the predicate system(s) with respect to<br>technical characteristics, performance, and intended use. The<br>information provided within this premarket notification supports<br>substantial equivalence of the subject device to the predicate device(s). |

{4}------------------------------------------------