(105 days)
Not Found
No
The summary describes a 3D printed interbody fusion device and associated hardware, focusing on its physical characteristics, materials, and mechanical testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a lumbar intervertebral fusion device used to treat degenerative disc disease and degenerative scoliosis, which are conditions that benefit from therapeutic intervention.
No
The provided text describes TrellOss™-L MPF as a "lateral interbody fusion device" and details its use in spinal fusion procedures. It does not mention any diagnostic functions, but rather its purpose as an implant for treatment.
No
The device description clearly describes a physical implant (3D printed, lateral interbody fusion device) and associated hardware (plates and screws). There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that TrellOss™-L MPF is a lumbar intervertebral fusion device intended for surgical implantation in the spine to treat degenerative disc disease and degenerative scoliosis. It is a physical implant used to facilitate bone fusion.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is structural and therapeutic.
Therefore, TrellOss™-L MPF falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used as a lumbar intervertebral fusion device. TrellOss™-L MPF is indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, TrellOss™-L MPF can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. TrellOss™-L MPF is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
TrellOss™-L MPF interbody implants with 14° lordosis or greater are only indicated for lumbar levels L2—L5 and are to be used with at least a 1-hole Timberline® MPF plate and screw construct.
Product codes
MAX, OVD
Device Description
TrellOss™-L MPF is a 3D printed, lateral interbody fusion device. The inferior/superior aspects of the TrellOss™-L MPF interbody incorporates two large vertical cavities which can be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft material. Each interbody comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700μm.
The TrellOss™-L MPF interbody can be used in conjunction with the Timberline® MPF plates and screws. The plate implants are offered having 1-, 2-, 3- or 4-holes to accommodate the vertebral screws. Cover plates secure the construct.
TrellOss™-L MPF interbody implants are provided sterile while the Timberline® MPF plate and screw implants are provided non-sterile. All devices are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2-S1
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)
The modified TrellOss™-L MPF interbody was evaluated via dimensional analyses with confirmatory static compression and dynamic compression shear testing per ASTM F2077. The results demonstrated the performance of the modified TrellOss™-L MPF is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
January 9, 2020
Nexxt Spine LLC % Karen E. Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K192687
Trade/Device Name: TrellOss™-L MPF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: November 12, 2019 Received: November 13, 2019
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.
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
1
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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter. PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality 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) K192687
Device Name TrellOss™-L MPF
Indications for Use (Describe)
When used as a lumbar intervertebral fusion device. TrellOss™-L MPF is indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, TrellOss™-L MPF can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. TrellOss™-L MPF is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
TrellOss™-L MPF interbody implants with 14° lordosis or greater are only indicated for lumbar levels L2—L5 and are to be used with at least a 1-hole Timberline® MPF plate and screw construct.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| Date: | 25 September 2019 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | TrellOss™-L MPF |
| Common Name: | Interbody fusion device |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Code: | Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX |
| Intervertebral fusion device with integrated fixation, lumbar, 888.3080, OVD | |
| Submission Purpose: | The subject 510(k) adds a lateral interbody, the TrellOss™-L MPF, to the |
| NEXXT MATRIXX® System. | |
| Device Description: | TrellOss™-L MPF is a 3D printed, lateral interbody fusion device. The |
| inferior/superior aspects of the TrellOss™-L MPF interbody incorporates | |
| two large vertical cavities which can be packed with autograft and/or | |
| allograft comprised of cancellous and/or corticocancellous bone graft | |
| material. Each interbody comprises an external structural frame having a | |
| roughened surface (~7µm). The intervening geometric lattices have pores | |
| 300-700μm. | |
| The TrellOss™-L MPF interbody can be used in conjunction with the | |
| Timberline® MPF plates and screws. The plate implants are offered having | |
| 1-, 2-, 3- or 4-holes to accommodate the vertebral screws. Cover plates | |
| secure the construct. | |
| TrellOss™-L MPF interbody implants are provided sterile while the | |
| Timberline® MPF plate and screw implants are provided non-sterile. All | |
| devices are available in an assortment of dimensional combinations to | |
| accommodate the individual anatomic and clinical circumstances of each | |
| patient. | |
| Indications for Use: | When used as a lumbar intervertebral fusion device, TrellOss™-L MPF is |
| indicated for use at one or two contiguous levels in the lumbar spine, from | |
| L2-S1, in skeletally mature patients who have had six months of non- | |
| operative treatment for the treatment of degenerative disc disease (DDD) | |
| with up to Grade 1 spondylolisthesis. DDD is defined as back pain of | |
| discogenic origin with degeneration of the disc confirmed by history and | |
| radiographic studies. Additionally, TrellOss™-L MPF can be used as an | |
| adjunct to fusion in patients diagnosed with degenerative scoliosis. | |
| TrellOss™-L MPF is intended for use with autograft and/or allograft | |
| comprised of cancellous and/or corticocancellous bone graft and with | |
| supplemental fixation. | |
| TrellOss™-L MPF interbody implants with 14° lordosis or greater are only | |
| indicated for lumbar levels L2-L5 and are to be used with at least a 1-hole | |
| Materials: | TrellOss™-L MPF interbody implants are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F3001). The Timberline® MPF plate and screw implants are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). |
| Primary Predicate: | NEXXT MATRIXX® System (Nexxt Spine, LLC – K171140) |
| Additional Predicates: | Biomet Fusion System (Biomet Spine - K163543) |
| Performance Data: | The modified TrellOss™-L MPF interbody was evaluated via dimensional analyses with confirmatory static compression and dynamic compression shear testing per ASTM F2077. The results demonstrated the performance of the modified TrellOss™-L MPF is substantially equivalent to the predicate. |
| Technological Characteristics: | The modified TrellOss™-L MPF interbody possesses the same technological characteristics as one or more of the predicate devices. These include: performance (as described above), basic design (additively manufactured structural interbody), material (titanium alloy) and size (dimensions are comparable to those offered by cleared devices). |
| Therefore the fundamental scientific technology of the modified TrellOss™-L MPF is the same as previously cleared devices. | |
| Conclusion: | The modified TrellOss™-L MPF possesses the same intended use and technological characteristics as the predicate devices. Therefore the modified TrellOss™-L MPF is substantially equivalent for its intended use. |
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