(59 days)
Not Found
No
The provided text describes surgical instruments for disc implantation, with no mention of AI models, machine learning, or image processing.
No
The device description clearly states that the prodisc® L Instruments are for the "placement, positioning, and removal of the prodisc® L implants." They are tools used in a surgical procedure, not devices that directly provide therapy to a patient.
No
The device is described as instruments intended for the placement, positioning, and removal of prodisc® L implants, which are used to implant a disc into the disc space. This indicates a surgical or interventional purpose rather than a diagnostic one.
No
The device is described as prodisc® L Instruments, which are physical tools used for the placement, positioning, and removal of implants. The description explicitly lists specific instrument names and sizes (e.g., "Hemi Chisel +3mm"), clearly indicating they are hardware devices, not software. There is no mention of software components, algorithms, or digital processing.
No
The device is described as surgical instruments intended for the placement, positioning, and removal of implants. This clearly indicates it is a surgical tool used directly on a patient's body for treatment, not for testing samples outside the body to diagnose or monitor medical conditions.
N/A
Intended Use / Indications for Use
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
Product codes
QLQ
Device Description
The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for four additional prodisc® L Instruments:
- IN1575, Hemi Chisel +3mm, 10mm
- IN1576, Hemi Chisel +3mm, 12mm
- IN1570, Superior Impactor, Medium
- IN1571, Superior Impactor, Large
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 25, 2025
Centinel Spine LLC
Jessica Staub
Sr. Director, RA/QA
900 Airport Road
Suite 3B
West Chester, Pennsylvania 19380
Re: K250554
Trade/Device Name: prodisc® L Instruments
Regulation Number: 21 CFR 888.4515
Regulation Name: Manual Instruments Designed For Use With Total Disc Replacement Devices
Regulatory Class: Class II
Product Code: QLQ
Dated: February 25, 2025
Received: February 25, 2025
Dear Jessica Staub:
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.
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K250554 - Jessica Staub Page 2
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).
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 QS 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 (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 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.
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-
Page 3
K250554 - Jessica Staub Page 3
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).
Sincerely,
STEPHANIE SMITH -S
For 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
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K250554
Please provide the device trade name(s). prodisc® L Instruments
Please provide your Indications for Use below.
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
Please select the types of uses (select one or both, as applicable).
- ☑ Prescription Use (Part 21 CFR 801 Subpart D)
- ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 5
510(k) Summary
Device Trade Name: prodisc® L Instruments
Manufacturer: Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Contact: Jessica Staub
Sr. Director of Regulatory Affairs
Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Prepared by: Jessica Staub
Sr. Director of Regulatory Affairs
Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Date Prepared: February 24, 2025
Classifications: 21 CFR §888.4515
Class: II
Product Codes: QLQ
Indications for Use:
The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.
Device Description:
The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for four additional prodisc® L Instruments:
- IN1575, Hemi Chisel +3mm, 10mm
- IN1576, Hemi Chisel +3mm, 12mm
- IN1570, Superior Impactor, Medium
- IN1571, Superior Impactor, Large
K250554, page 1 of 2
Page 6
K250554, page 2 of 2
These are new instruments, based on similar devices within the existing instrument set.
Primary Predicate Device:
Centinel Spine believes the prodisc® L Instruments are substantially equivalent to the following primary predicate device with respect to intended use, design, and materials:
- prodisc® L Instruments, Centinel Spine LLC, K242869
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate devices with respect to indications, design, materials, function, manufacturing, and performance.
Conclusion:
Based on the information provided above, the prodisc® L Instruments are substantially equivalent to the cited primary predicate.