BEE PLIF Cage
Device Facts
| Record ID | K261067 |
|---|---|
| Device Name | BEE PLIF Cage |
| Applicant | NGMedical GmbH |
| Product Code | MAX · Orthopedic |
| Decision Date | Apr 30, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
BEE® PLIF cages and NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Device Story
BEE PLIF Cage is a lumbar interbody fusion device; implanted via posterior approach (open or minimally invasive) to treat degenerative disc disease. Device provides structural support to intervertebral space; used with autogenous/allogeneic bone graft to facilitate fusion; requires supplemental fixation instrumentation. Implant features rough cranial/caudal surfaces for stability; manufactured via additive manufacturing. Surgeon selects appropriate size/lordotic angle based on patient anatomy. Device benefits patient by stabilizing spinal segment and promoting fusion.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including confirmatory dynamic compression shear and dynamic torsion per ASTM F2077, and pyrogenicity testing to confirm acceptable endotoxin levels.
Technological Characteristics
Titanium alloy per ASTM F3001; additive manufacturing; rough cranial/caudal surfaces for stability; various footprints and lordotic angles; ethylene oxide sterilization.
Indications for Use
Indicated for interbody fusion in skeletally mature patients with degenerative disc disease (DDD) at 1-2 contiguous levels (L2-S1), including those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed 6 months of 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
- NG Medical - BEE PLIF Cages - K211413
- EIT Emerging Implant Technologies GmbH - EIT Cellular Titanium® PLIF Cages - K170503
- EIT Emerging Implant Technologies GmbH - EIT Cellular Titanium® PLIF Cages - K201605
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
April 30, 2026
NGMedical GmbH
% Jen McBride
Regulatory Consultant
MRC Global, LLC
Contact Address
Re: K261067
Trade/Device Name: BEE PLIF Cage
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Dated: March 31, 2026
Received: April 1, 2026
Dear Ms. McBride:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K261067 - Jen McBride
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
{2}
K261067 - Jen McBride
Page 3
Sincerely,
Brent Showalter -S
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
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K261067
Device Name
BEE PLIF Cages
Indications for Use (Describe)
BEE® PLIF cages and NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
{4}
K261067
510(k) Summary
BEE PLIF Cages
29 April 2026
Company: NGMedical GmbH
Trierer Strasse 65
Nonnweiler DE 66620
+49 6873 99997-100
Company Contact: Stella Hahn – Head of Regulatory Affairs
+49 6873 99997-100
Official Correspondent: Jen McBride – MRC Global, LLC
jen.mcbride@askmrcglobal.com
901-481-5902
Trade Name: BEE PLIF Cages
Common Name: Intervertebral Fusion Device With Bone Graft, Lumbar
Classification: Class II
Regulation Number: 21 CFR 888.3080 (Intervertebral body fusion device)
Panel: Orthopedic
Product Code: MAX
Device Description:
The subject BEE PLIF Cage is a lumbar interbody fusion device. BEE PLIF Cage is manufactured from titanium alloy per ASTM F3001 via additive manufacturing. The BEE PLIF Cage is an intervertebral body fusion device for treatment of lumbar disc degeneration utilizing the posterior lateral approach. BEE PLIF Cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The cranial and caudal side of the implant is rough to provide increased stability and to help prevent movement of the device.
The purpose of this submission is to expand the size offerings of the PLIF and to modify the implant sterilization method from gamma irradiation to ethylene oxide.
Indications for Use:
BEE® PLIF cages and NGM WAVE® PLIF cages are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients
Page 1 of 2
{5}
may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Substantial Equivalence:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate:
NG Medical - BEE PLIF Cages - K211413
Additional Predicate: EIT Emerging Implant Technologies GmbH - EIT Cellular Titanium® PLIF Cages - K170503, K201605
The subject and primary predicate device are identical in Intended Use,. The subject device is similar to the predicate devices in Technological Characteristics, Performance Specifications, and Material. The subject BEE PLIF Cage is manufactured from material identical to the primary predicate, using similar manufacturing processes. All subject geometry and sizing is similar to those provided by the predicate devices.
Performance Testing:
Confirmatory dynamic compression shear and dynamic torsion per ASTM F2077 were performed to confirm the determination that no new worst case has been created by the subject modifications and size expansion. The change in sterilization is also not expected to impact device performance. Therefore, no additional performance testing is required. In addition, pyrogenicity, testing was performed on the subject devices, confirming acceptable levels of endotoxins.
Conclusion:
Based on the test results and the comparison to the predicate device, the subject device is determined to be substantially equivalent to the predicate device.
