(49 days)
Not Found
No
The description focuses on the materials, design, and mechanical properties of the interbody fusion devices and associated hardware. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML.
Yes
This device is designed to treat degenerative disc disease and facilitate spinal fusion, which are therapeutic interventions.
No
The device is an interbody fusion device intended for use in spinal fusion procedures. It is an implant used for treatment, not for diagnosing a condition.
No
The device description clearly details physical implants (interbody fusion devices, plates, bone screws, locking covers) made from materials like PEEK, tantalum, and titanium alloy, as well as associated instruments. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The Shoreline ACS and RT Interbody Systems are implants designed to be surgically placed within the cervical spine. They do not analyze biological samples.
- The intended use is for spinal fusion procedures. The purpose of these devices is to provide structural support and facilitate bone fusion in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test.
- The device description details materials and surgical components. The description focuses on the physical composition of the implants (PEEK, tantalum, titanium alloy) and associated instruments for surgical placement. This is consistent with a medical device intended for implantation, not an IVD.
The mention of "radiographic studies" is for confirming the diagnosis of degenerative disc disease and assessing the outcome of the fusion procedure, not as an input for the device itself to perform a diagnostic function.
N/A
Intended Use / Indications for Use
Shoreline ACS Interbody System:
The Shoreline ACS Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and No-profile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.
When the Shoreline ACS Interbody (excluding the No-profile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).
Shoreline RT Interbody System:
The Shoreline RT Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.
When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).
Product codes
OVE, ODP
Device Description
Shoreline ACS Interbody System:
The Shoreline ACS Interbody System featuring NanoMetalene® surface technology consists of single-use anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.
The Shoreline ACS Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configurations. Each TruProfile and No-profile construct must be used with the maximum number of screws allowed by the plate interface. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
Shoreline RT Interbody System:
The Shoreline RT Interbody System featuring NanoMetalene® surface technology consists of single-use anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.
The Shoreline RT Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System nonsterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configuration. Each TruProfile construct must be used with the maximum number of screws allowed by the plate interface. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Cervical spine (C2-T1)
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)
Mechanical performance in static and dynamic axial compression shear, and torsion (per ASTM F2077) and subsidence (per ASTM F2267) was verified for the Shoreline ACS Interbody System and Shoreline RT Interbody System through engineering analysis.
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 28, 2023
SeaSpine Orthopedics Corporation Kendal Moulton Regulatory Affairs Associate 5770 Armada Drive Carlsbad, California 92008
Re: K233414
Trade/Device Name: Shoreline ACS Interbody System; Shoreline RT Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: October 6, 2023 Received: October 10, 2023
Dear Kendal Moulton:
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
2
Indications for Use
Submission Number (if known)
Device Name
Shoreline ACS Interbody System: Shoreline RT Interbody System
Indications for Use (Describe)
Shoreline ACS Interbody System:
The Shoreline ACS Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be
skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and No-profile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.
When the Shoreline ACS Interbody (excluding the No-profile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).
Shoreline RT Interbody System:
The Shoreline RT Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.
When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | 5770 Armada Drive, Carlsbad, CA 92008 |
| Phone number: | (760) 216-5176 |
| Fax number: | (760) 683-6874 |
| Contact Person: | Kendal Moulton, Regulatory Affairs Associate |
| Date Prepared: | October 6, 2023 |
Device Name
| Trade Name(s): | Shoreline ACS Interbody System
Shoreline RT Interbody System |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Cervical (21 CFR 888.3080)
Intervertebral Fusion Device With Integrated Fixation, Cervical (21 CFR 888.3080) |
| Product Code(s): | OVE, ODP |
| Device Class: | 2 |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code(s) | Trade Name(s) | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K201193 | OVE, ODP | Shoreline ACS (Anterior Cervical System) & Shoreline Cervical Interbody RT System | SeaSpine |
| Orthopedics | |||
| Corporation | |||
| Additional Predicate Device(s) | |||
| K212904 | OVE, ODP | WaveForm C Interbody System | SeaSpine |
| Orthopedics | |||
| Corporation |
Device Description
Shoreline ACS Interbody System
The Shoreline ACS Interbody System featuring NanoMetalene® surface technology consists of single-use anterior cervical intervertebral body fusion devices manufactured from
5
polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.
The Shoreline ACS Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configurations. Each TruProfile and No-profile construct must be used with the maximum number of screws allowed by the plate interface. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
Shoreline RT Interbody System
The Shoreline RT Interbody System featuring NanoMetalene® surface technology consists of single-use anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized.
The Shoreline RT Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System nonsterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configuration. Each TruProfile construct must be used with the maximum number of screws allowed by the plate interface. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that
6
may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
Intended Use/Indications for Use
Shoreline ACS Interbody System
The Shoreline ACS Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and No-profile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.
When the Shoreline ACS Interbody (excluding the No-profile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).
Shoreline RT Interbody System
The Shoreline RT Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation.
When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).
7
Summary of Technological Characteristics
The Shoreline ACS Interbody System and Shoreline RT Interbody System are identical or similar to the cited predicate systems in regard to intended use/indications for use, device description, technological characteristics (e.g., operating principle, design, components, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., mechanical testing).
Non-Clinical Testing
Mechanical performance in static and dynamic axial compression shear, and torsion (per ASTM F2077) and subsidence (per ASTM F2267) was verified for the Shoreline ACS Interbody System and Shoreline RT Interbody System through engineering analysis.
Clinical Testing
Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrates that the Shoreline ACS Interbody System and Shoreline RT Interbody System are substantially equivalent to the cited legally marketed predicates.