BEE Cages

K200429 · NGMedical GmbH · ODP · Jan 29, 2021 · Orthopedic

Device Facts

• Record ID: K200429
• Device Name: BEE Cages
• Applicant: NGMedical GmbH
• Product Code: ODP · Orthopedic
• Decision Date: Jan 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BEE Cervical Cages were developed as an intercorporal implant for the anterior cervical spondylodesis.

Device Story

BEE Cervical Cage is an intervertebral body fusion device used in anterior cervical discectomy and fusion (ACDF) procedures. Implant features tapered nose for insertion, convex superior/flat inferior surfaces for anatomical fit, and honeycomb geometry for bone graft packing. Available in multiple widths, depths, heights, and lordotic angles. Used by surgeons in clinical settings to maintain disc space and facilitate bony fusion in the cervical spine. Benefits include stabilization of the spinal segment and promotion of fusion in patients with degenerative disc disease or instability.

Clinical Evidence

Clinical evidence provided to demonstrate that the device's lattice structure does not obstruct the development of fusion.

Technological Characteristics

Materials: ASTM F136 (Ti-6Al-4V ELI), ASTM F3001 (Additive Manufacturing Ti-6Al-4V ELI), ASTM F2924 (Additive Manufacturing Ti-6Al-4V). Design: Honeycomb geometry, tapered nose, lordotic angles. Principle: Intervertebral body fusion device. Connectivity: None (mechanical implant).

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability (confirmed by imaging) resulting in radiculopathy, myelopathy, and/or pain at 1-2 contiguous levels from C2-T1. Requires at least 6 weeks of failed nonoperative treatment. Must be used with autogenous/allogeneic bone graft and supplemental cervical fixation.

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

• EIT Cellular Titanium® Cervical Cage - EIT Emerging Implant Technologies GmbH (K170503)

Reference Devices

• Crystal® - Spinal Elements, Inc. (K073351)

Submission Summary (Full Text)

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January 29, 2021

NGMedical GmbH % Christine Scifert Official Correspondent MRC Global 9085 East Mineral Circle, Suite 110 Centennial, Colorado 80112

Re: K200429

Trade/Device Name: BEE Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 22, 2021 Received: January 25, 2021

Dear Christine Scifert:

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 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 ([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

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# Indications for Use

510(k) Number (if known) K200429

Device Name BEE Cage

#### Indications for Use (Describe)

BEE Cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or two contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary: BEE Cervical Cages

| Date Prepared | January 28, 2021 |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | NGMedical GmbH<br>Morschborn 28<br>66620 Nonnweiler<br>GERMANY<br>[phone] |
| Primary Contact | Christine Scifert<br>MRC Global<br>[e-mail]<br>901-831-8053 |
| Trade Name | BEE Cervical Cages |
| Common Name | Cervical cage |
| Classification Name | Intervertebral body fusion device - cervical |
| Class | II |
| Product Code | ODP |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | EIT Cellular Titanium® Cervical Cage - EIT Emerging Implant Technologies GmbH<br>(K170503) |
| Reference Predicate<br>Devices | Crystal® - Spinal Elements, Inc. (K073351) |
| Device Description | The BEE Cervical Cage is an intervertebral body fusion device for treatment of cervical<br>disc degeneration and/or cervical instability utilizing the anterior cervical discectomy and<br>fusion surgical technique. The tapered nose design provides ease of insertion while the<br>convex superior and flat inferior surfaces replicate the patient's vertebral anatomical<br>architecture for maximum surface contact. The cranial and caudal surfaces have a<br>honeycomb geometry that accepts packing of bone graft to help facilitate bony integration.<br>The device consists of implants available in two widths, one depth, seven heights, and<br>three lordotic angles. |
| Materials | ASTM F136 - Wrought Titanium-6Aluminum-4Vanadium ELI<br>ASTM F3001 - ASTM F3001 Additive Manufacturing Titanium-6 Aluminum-4 Vanadium<br>ELI<br>ASTM F2924 - ASTM F2924 Additive Manufacturing Titanium-6 Aluminum-4 Vanadium |
| Intended Use | BEE Cervical Cages were developed as an intercorporal implant for the anterior cervical<br>spondylodesis. |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The BEE Cervical Cages are substantially equivalent to the predicate devices in terms<br>of intended use, design, materials used, mechanical safety and performances. |
| Indications for Use | BEE Cages are intended for intervertebral body fusion devices in skeletally mature patients<br>for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed<br>by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or<br>pain at one or two contiguous levels from C2-T1. These patients should have had at least<br>six weeks of nonoperative treatment. BEE Cages are to be used with autogenous and/or<br>allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to<br>facilitate fusion and in combination with supplemental fixation indicated for cervical fusion<br>procedures. |
| Summary of the<br>technological<br>characteristics<br>compared to<br>predicate | Intended Use<br>The BEE Cervical Cages and the predicate devices are all intended to be used to<br>maintain adequate disc space until fusion occurs.<br><br>Indications for Use<br>All of the devices comply with the indications for use specified in 21 CFR section<br>888.3080 for cervical interbody fusion devices |
| | Material<br>The BEE Cervical Cage uses the same material as the predicate device.<br><br>Design<br>The BEE Cervical Cage and the predicate are equivalent in terms of shape, material, and<br>manufacturing process. |
| | Sizes<br>The BEE Cervical Cage and the predicates are equivalent in their dimensions.<br><br>Strength<br>The BEE Cervical Cage has greater or equivalent strength values compared to other<br>devices cleared for use in the cervical spine. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>• ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices<br>• ASTM F2267 - Measuring Load Induced Subsidence of Intervertebral Body<br>Fusion Device Under Static Axial Compression<br><br>The results of these evaluations indicate that the BEE Cervical Cages are equivalent to<br>predicate devices. |
| Clinical Test<br>Summary | Clinical evidence was provided to demonstrate that the lattice structure did not obstruct the<br>development of fusion. |
| Conclusions: Non-<br>clinical and Clinical | NGMedical considers the BEE Cervical Cages to be equivalent to the predicate devices<br>listed above. This conclusion is based upon the devices' similarities in principles of<br>operation, technology, materials and indications for use. |

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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