(59 days)
K220861 - M6-C Artificial Cervical Disc Instruments AS
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No
The document describes surgical instruments for implanting a cervical disc and does not mention any AI or ML components.
No.
The device described consists of instruments intended for the placement and positioning of an artificial cervical disc, not the disc itself or a standalone therapeutic function.
No
The device description clearly states its purpose is for the placement and positioning of an artificial cervical disc, which are surgical instrumentation functions, not diagnostic ones.
No
The device description explicitly states it is composed of physical materials (reinforced polyacrylamide and surgical stainless steel) and is intended for surgical implantation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "placement and positioning of the M6-C Artificial Cervical Disc." This describes a surgical instrument used during a surgical procedure on a patient.
- Device Description: The description details surgical instruments like templates, trials, fin cutters, and inserters used to implant an artificial disc. These are tools for a surgical procedure, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for implantation.
N/A
Intended Use / Indications for Use
The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.
Product codes (comma separated list FDA assigned to the subject device)
QLQ
Device Description
The M6-C™ Artificial Cervical Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the cervical spine when replacing a degenerated native disc (PMA P170036). The surgical implantation of the M6-C Cervical Artificial Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the artificial disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, these are general surgical instruments to assist in the distraction and mobilization of the disc space. The single use instruments are composed primarily of reinforced polyacrylamide (PAA+50%GF) with some structural components made from surgical stainless steel and are intended to be reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine
Indicated Patient Age Range
Not Found
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)
M6-C™ Single Use, Disposable Instrumentation has been evaluated via the following performance testing:
- Impact Testing
- Bend/Functional Testing
- Sterilization and Biocompatibility Testing
The results demonstrated the performance of M6-C™ Single Use, Disposable Instrumentation is substantially equivalent to the reusable M6-C Artificial Cervical Disc Instrument predicate device.
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.
K220861 - M6-C Artificial Cervical Disc Instruments AS
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2024
Spinal Kinetics / Orthofix / SeaSpine Tony John Regulatory Affairs Program Manager 501 Mercury Drive Sunnyvale, California 94085
Re: K241117
Trade/Device Name: M6-C™ Single Use, Disposable Instrumentation Regulation Number: 21 CFR 888.4515 Regulation Name: Orthopedic Manual Surgical Instrumentation For Use With Total Disc Replacement Devices Regulatory Class: Class II Product Code: QLQ Dated: April 22, 2024 Received: April 23, 2024
Dear Tony John:
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" (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).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 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-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 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.
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-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 -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
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Indications for Use
Submission Number (if known)
Device Name
M6-C™ Single Use, Disposable Instrumentation
Indications for Use (Describe)
The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.
Type of Use (Select one or both, as applicable)
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 Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
3
Image /page/3/Picture/1 description: The image shows the logo for SpinalKinetics. The logo consists of a blue spine graphic on the left, followed by the word "Spinal" in blue and "Kinetics" in gray. The letters "TM" are in superscript to the right of the word Kinetics.
510(k) Summary
| Device Trade Name: | M6-C™ Single Use, Disposable Instrumentation |
|---|---|
| Manufacturer: | Spinal Kinetics LLC |
| 501 Mercury Drive | |
| Sunnyvale, CA 94085 | |
| USA | |
| Contact Person: | Tony John |
| Program Manager, Regulatory Affairs | |
| Orthofix/Spinal Kinetics/SeaSpine | |
| 3451 Plano Parkway | |
| Lewisville, TX 75056 | |
| Phone: (214) 937-2153 | |
| tonyjohn@orthofix.com | |
| Date Prepared: | April 22, 2024 |
| Registration Number: | 3004987282 |
| Product Code: | QLQ |
| Classifications: | Class II - 21 CFR §888.4515 |
| Classification Name: | Orthopedic manual surgical instrumentation for use with total disc |
| replacement devices | |
| Primary Predicate: | K220861 - M6-C Artificial Cervical Disc Instruments AS |
Reason for the 510(k) Submission:
To introduce a single-use version of the existing re-usable M6-C Cervical Surgical Instrumentation cleared under K220861.
Device Description:
The M6-C™ Artificial Cervical Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the cervical spine when replacing a degenerated native disc (PMA P170036). The surgical implantation of the M6-C Cervical Artificial Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the artificial disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, these are general surgical instruments to assist in the distraction and mobilization of the disc space. The single use instruments are composed primarily of reinforced polyacrylamide (PAA+50%GF) with some structural components made from surgical stainless steel and are intended to be reusable.
4
Image /page/4/Picture/1 description: The image shows the logo for Spinal Kinetics. The word "Spinal" is in blue, and the word "Kinetics" is in gray. To the left of the word "Spinal" is a blue spine-like graphic. The letters "TM" are in superscript to the right of the word "Kinetics".
Indications for Use:
The M6-CTM Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-CTM Artificial Cervical Disc.
Performance Testing Summary:
M6-CTM Single Use, Disposable Instrumentation has been evaluated via the following performance testing:
- Impact Testing
- Bend/Functional Testing
- . Sterilization and Biocompatibility Testing
The results demonstrated the performance of M6-CTM Single Use, Disposable Instrumentation is substantially equivalent to the reusable M6-C Artificial Cervical Disc Instrument predicate device.
Substantial Equivalence:
The subject device is substantially equivalent to the M6-C Artificial Cervical Disc Instrument predicate devices with respect to indication, design, materials, function, and performance.
Conclusion:
M6-C™ Single Use, Disposable Instrumentation has the same intended use, indications for use as the predicate M6-C Artificial Cervical Disc Instrument predicate. The minor difference in technological characteristics do not raise any new question of safety or effectiveness and the sterilization, biocompatibility, and performance testing demonstrates that the subject device is substantial equivalent to the predicate device.