(288 days)
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.
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.
This document describes the Lucero Medical Cervical Spacer System, an intervertebral body fusion device. The acceptance criteria and performance are based on mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Standard) | Reported Device Performance (Worst Case) |
|---|---|---|
| Static Compression | ASTM F2077 | Meets standard (substantially equivalent to predicates) |
| Dynamic Compression | ASTM F2077 | Meets standard (substantially equivalent to predicates) |
| Static Torsion | ASTM F2077 | Meets standard (substantially equivalent to predicates) |
| Subsidence | ASTM F2267 | Meets standard |
| Expulsion | Not explicitly stated in terms of standard but implied by predicate comparison | Performed and meets criteria (substantially equivalent to predicates) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of Lucero Medical Cervical Spacers used in the mechanical testing (the test set sample size). It refers to "worst-case Lucero Medical Cervical Spacer." The data provenance is internal testing performed by Lucero Medical, LLC, to demonstrate substantial equivalence to legally marketed predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is a medical device for orthopedic surgery, and the "ground truth" for mechanical testing is established by adherence to recognized ASTM standards (F2077, F2267) rather than expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements against established engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The device is a physical implant, not an AI or imaging-based diagnostic tool. The performance evaluation is based on mechanical properties and substantial equivalence to existing devices.
6. Standalone Performance Study (Algorithm Only)
No, a standalone performance study was not done as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" used for device performance is based on established engineering standards for intervertebral body fusion devices, specifically ASTM F2077 for static and dynamic compression and static torsion, and ASTM F2267 for subsidence.
8. Sample Size for the Training Set
Not applicable. Mechanical testing of physical devices does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device evaluation.
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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) |
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510(k) Summary
| Date: | 2 March 2020 |
|---|---|
| Sponsor: | Lucero Medical, LLC6815 West StreetsboroRichfield, OH 44286Office: 330.659.0855 |
| Sponsor Contact: | Lee Strnad, CEO |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 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 manufacturedinterbody 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 toaccommodate the anatomic requirements of individual patients. The devicesare provided sterile. |
| Indications for Use: | The Lucero Medical Cervical Spacer is intended for anterior intervertebralbody fusion in skeletally mature patients who have had at least six weeks ofnon-operative treatment. The Lucero Medical Cervical Spacer is indicated totreat cervical disc degeneration and/or cervical spinal instability, asconfirmed by imaging studies (radiographs, CT, MRI), that results inradiculopathy, myelopathy, and/or pain at multiple contiguous levels fromC2 - T1. The Lucero Medical Cervical Spacer is designed for use withautogenous and/or allogeneic bone graft comprised of cancellous and/orcorticocancellous bone to facilitate fusion and to be used with supplementalfixation 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 Spacerincluded static and dynamic compression and static torsion according toASTM F2077. In addition, subsidence according to ASTM F2267 andexpulsion tests were performed.The mechanical test results demonstrate that the Lucero Medical CervicalSpacer System performance is substantially equivalent to the predicatedevices. |
| TechnologicalCharacteristics: | The Lucero Medical Cervical Spacer System possesses the sametechnological characteristics as one or more of the predicate devices. Theseinclude:• intended use (as described above)• basic design (additively manufactured structure),• material (titanium alloy) and• sizes (dimensions are comparable to those offered by the predicatesystems)The Lucero Medical Cervical Spacer is the same as previously cleareddevices. |
| Conclusion: | The Lucero Medical Cervical Spacer System possesses the same intendeduse and technological characteristics as the predicate devices. Thereforethe Lucero Medical Cervical Spacer System is substantially equivalent forits intended use. |
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§ 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.