(70 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is described as a "spinal fixation system" and "temporary implants that are intended for anterior interbody screw fixation of the cervical spine (C2-T1) during the development of a cervical spinal fusion." These functions directly involve treating or mitigating medical conditions of the spine.
No
Explanation: The device description states that the Shoreline Threaded TruProfile Plate is a spinal fixation system, which is an implant used for anterior cervical fixation. It is not mentioned as detecting or diagnosing any condition.
No
The device description explicitly states it is a spinal fixation system consisting of plates, screws, and locking covers made from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The Shoreline Threaded TruProfile® Plate is a spinal fixation system that is surgically implanted into the body to stabilize the cervical spine. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for anterior cervical fixation for various spinal conditions. This involves a surgical procedure and the device remains within the patient's body.
Therefore, based on the provided information, the Shoreline Threaded TruProfile® Plate is a medical device (specifically, an implantable surgical device), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Shoreline Threaded TruProfile® Plate is intended for anterior cervical fixation (C2-T1) for the following indications: · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), · Spondylolisthesis, - · Trauma (i.e., fracture or dislocation), · Spinal Stenosis, - · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - · Tumor, - · Pseudarthrosis. - · Failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Shoreline Threaded TruProfile" Plate (referred to as the TruProfile Plate) is a spinal fixation system that consists of a variety of non-sterile, single-use plates, screws, and locking covers. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Shoreline plates include locking covers that cover the heads of the bone screws to reduce the potential for screw back-out. The TruProfile Plate implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The TruProfile Plate implant components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine (C2- T1) during the development of a cervical spinal fusion. Associated instruments are available to facilitate the implantation of the device. The instruments are placed in system-specific tray components for storage, protection, and organization prior to and during the steam sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
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)
The TruProfile Plate has demonstrated equivalent mechanical performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717.
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
August 30, 2021
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SeaSpine Orthopedics Corporation Kavita Chandrashekar Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K211903
Trade/Device Name: Shoreline Threaded TruProfile® Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 18, 2021 Received: June 21, 2021
Dear Kavita Chandrashekar:
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/cdrl/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 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
1
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 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/cdrl-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.
for
Colin O'Neill, M.B.E. 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name Shoreline Threaded TruProfile® Plate
Indications for Use (Describe)
The Shoreline Threaded TruProfile® Plate is intended for anterior cervical fixation (C2-T1) for the following indications: · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
· Spondylolisthesis,
-
· Trauma (i.e., fracture or dislocation),
· Spinal Stenosis, -
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
· Tumor,
-
· Pseudarthrosis.
-
· Failed previous fusion.
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
K211903
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA |
| Phone number: | (858) 405-1276 (Kavita) |
| Fax number: | (760) 683-6874 |
| Contact person: | Kavita Chandrashekar, Regulatory Affairs Specialist, Regulatory Affairs |
| Date Prepared: | June 18, 2021 |
| Device Name | |
| Trade Name: | Shoreline Threaded TruProfile® Plate |
| Device Classification Regulation: | 888.3060 |
| Common Name: | Cervical Plate |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Class: | II |
| Product Code: | KWQ |
4
Legally Marketed Predicate Devices
| 510(k) Number | Product
Code | Trade Name | Manufacturer |
|------------------------------|-----------------|----------------------------------------------------------|----------------------------------|
| Primary Predicate Device | | | |
| K202064 | KWQ | SeaSpine Admiral Anterior
Cervical Plate (ACP) System | SeaSpine Orthopedics Corporation |
| Additional Predicate Devices | | | |
| K190885 | OVE, ODP, KWQ | Elevation Spine Saber-C
System | Elevation Spine |
| K173521 | KWQ | SeaSpine Cabo ACP System | SeaSpine Orthopedics Corporation |
Device Description
The Shoreline Threaded TruProfile" Plate (referred to as the TruProfile Plate) is a spinal fixation system that consists of a variety of non-sterile, single-use plates, screws, and locking covers. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Shoreline plates include locking covers that cover the heads of the bone screws to reduce the potential for screw back-out. The TruProfile Plate implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The TruProfile Plate implant components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine (C2- T1) during the development of a cervical spinal fusion. Associated instruments are available to facilitate the implantation of the device. The instruments are placed in system-specific tray components for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for Use
The Shoreline Threaded TruProfile" Plate is intended for anterior cervical fixation (C2—T1) for the following indications:
- . Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation),
- . Spinal Stenosis,
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- Pseudarthrosis,
- Failed previous fusion.
5
Summary of Technological Characteristics
The TruProfile Plate is identical or similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
The plates are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
Non-Clinical Testing
The TruProfile Plate has demonstrated equivalent mechanical performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717.
Conclusions
The submitted data demonstrates that the Shoreline TruProfile Plate is substantially equivalent to the cited legally marketed predicate.