K Number
K200549
Device Name
Lucero Medical Cervical Cage System
Date Cleared
2020-12-16

(288 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat 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 multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.
Device Description
The Lucero Medical Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone cross-sectional shape and an open structural architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The devices are provided sterile.
More Information

Not Found

No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.

Yes
The device is intended to treat cervical disc degeneration and/or cervical spinal instability, and facilitate fusion, indicating a therapeutic purpose.

No
The device is an implantable medical device (cervical spacer) used for fusion and stabilization, not for diagnosing conditions. It is used to treat conditions confirmed by imaging studies, but it does not perform the diagnostic imaging or interpretation itself.

No

The device description explicitly states it is an "additively manufactured interbody device," which is a physical implant, not software.

Based on the provided information, the Lucero Medical Cervical Spacer is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens from the human body. This device is an implantable medical device designed to be surgically placed within the cervical spine.
  • The intended use describes a surgical procedure and treatment of a medical condition. It does not involve testing or analyzing biological samples.
  • The device description details a physical implant. It does not describe reagents, kits, or instruments used for laboratory testing.

The information clearly indicates this is a surgical implant used for spinal fusion, not a diagnostic tool.

N/A

Intended Use / Indications for Use

The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat 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 multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.

Product codes (comma separated list FDA assigned to the subject device)

ODP

Device Description

The Lucero Medical Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone cross-sectional shape and an open structural architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The devices are provided sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

radiographs, CT, MRI

Anatomical Site

cervical disc degeneration and/or cervical spinal instability, C2 - T1

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)

Mechanical testing of the worst case Lucero Medical Cervical Spacer included static and dynamic compression and static torsion according to ASTM F2077. In addition, subsidence according to ASTM F2267 and expulsion tests were performed. The mechanical test results demonstrate that the Lucero Medical Cervical Spacer System performance is substantially equivalent to the predicate devices.

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.

K160125, K181483, K091088

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.

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December 16, 2020

Lucero Medical, LLC % Karen E. Warden, PhD President BackRoads Consulting, Inc 12520 Heath Road Chesterland, Ohio 44026

Re: K200549

Trade/Device Name: Lucero Medical Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 9, 2020 Received: December 10, 2020

Dear Dr. Warden:

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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Brent L. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200549

Device Name Lucero Medical Cervical Spacer System

Indications for Use (Describe)

The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat 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 multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical 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
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510(k) Summary

Date:2 March 2020
Sponsor:Lucero Medical, LLC
6815 West Streetsboro
Richfield, OH 44286
Office: 330.659.0855
Sponsor Contact:Lee Strnad, CEO
510(k) Contact:Karen E. Warden, PhD
BackRoads Consulting Inc.
PO Box 566
Chesterland, OH 44026
Office: 440.729.8457
Proposed Trade Name:Lucero Medical Cervical Spacer System
Common Name:Cervical interbody fusion device
Device Classification:Class II
Regulation Names,
Regulation Numbers,
Product Codes:Intervertebral fusion device with bone graft, 888.3080, cervical, ODP
Device Description:The Lucero Medical Cervical Spacer is an additively manufactured
interbody device. These cervical implants have basic keystone cross-
sectional shape and an open structural architecture. A variety of height,
length, width and anteroposterior angulation combinations are available to
accommodate the anatomic requirements of individual patients. The devices
are provided sterile.
Indications for Use:The Lucero Medical Cervical Spacer is intended for anterior intervertebral
body fusion in skeletally mature patients who have had at least six weeks of
non-operative treatment. The Lucero Medical Cervical Spacer is indicated to
treat 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 multiple contiguous levels from
C2 - T1. The Lucero Medical Cervical Spacer is designed for use with
autogenous and/or allogeneic bone graft comprised of cancellous and/or
corticocancellous bone to facilitate fusion and to be used with supplemental
fixation cleared for use in the cervical spine.
Materials:The Lucero Medical Cervical Spacer implants are manufactured from Ti-
6Al-4V ELI titanium alloy (ASTM F3001).
Primary Predicate:Cascadia Interbody System (K2M Inc. - K160125)
Additional Predicates:Tranquil™ Interbody System System (Nexus Spine, LLC. - K181483), MC+
(LDR Holding - K091088)
Performance Data:Mechanical testing of the worst case Lucero Medical Cervical Spacer
included static and dynamic compression and static torsion according to
ASTM F2077. In addition, subsidence according to ASTM F2267 and
expulsion tests were performed.
The mechanical test results demonstrate that the Lucero Medical Cervical
Spacer System performance is substantially equivalent to the predicate
devices.
Technological
Characteristics:The Lucero Medical Cervical Spacer System possesses the same
technological characteristics as one or more of the predicate devices. These
include:
• intended use (as described above)
• basic design (additively manufactured structure),
• material (titanium alloy) and
• sizes (dimensions are comparable to those offered by the predicate
systems)
The Lucero Medical Cervical Spacer is the same as previously cleared
devices.
Conclusion:The Lucero Medical Cervical Spacer System possesses the same intended
use and technological characteristics as the predicate devices. Therefore
the Lucero Medical Cervical Spacer System is substantially equivalent for
its intended use.

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