(92 days)
Not Found
No
The summary describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or AI/ML capabilities.
Yes
This device is an interbody fusion device intended for use in patients with degenerative disc disease for spinal fusion procedures. This falls under the definition of a therapeutic device as it treats a condition.
No
Explanation: This device is an interbody fusion device intended for use in spinal fusion procedures, acting as an implant to aid in the fusion of the cervical spine. It does not perform any diagnostic functions.
No
The device description clearly states it is an "additively manufactured implant comprised of cervical spacers" made from "Ti-6Al-4V ELI titanium alloy," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The SeaSpine WaveForm™ C Interbody System is described as an "additively manufactured implant comprised of cervical spacers." These are physical devices implanted into the body.
- Intended Use: The intended use is for spinal fusion procedures in the cervical spine, which is a surgical intervention, not a diagnostic test performed on a sample.
The text clearly describes a surgical implant used for structural support and fusion in the spine, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature paient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. 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 WaveForm™ C Interbody System, the 2,3,4 hole TruProfile spacers and plates, are intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T), and must be used with bone screw fixation and locking covers. The No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-Tl), and must be used with bone screw fixation and locking covers.
When the WaveForm™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interded to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-TI).
Product codes
OVE, ODP
Device Description
The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™ C Interbody System offers spacers in low profile (TruProfile) and no profile versions in various lengths and are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001.
The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays 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
skeletally mature patient
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 WaveForm™ C Interbody System has been testing in accordance with requirements outlined in ASTM F2077, F2267, and F1877.
The submitted data demonstrates that the SeaSpine WaveForm™ C Interbody System performs at least as safely and effectively as the cited legally marketed predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K201073, K161081, K172676, K192582, K172064, K211258
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
December 14, 2021
SeaSpine Orthopedics Corporation Aly Alvarez Principal Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K212904
Trade/Device Name: SeaSpine WaveForm™ C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: September 11, 2021 Received: September 13, 2021
Dear Aly Alvarez:
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, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212904
Device Name WaveForm™ C Interbody System
Indications for Use (Describe)
The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature paient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. 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 WaveForm™ C Interbody System, the 2,3,4 hole TruProfile spacers and plates, are intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T), and must be used with bone screw fixation and locking covers. The No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-Tl), and must be used with bone screw fixation and locking covers.
When the WaveForm™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interded to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-TI).
| 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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3
510(k) Summary
K212904
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad CA |
| (760) 421-2793 (Hong) | |
| (760) 683-6874 | |
| Contact Person: | Hong Phan, Principal Regulatory Affairs Specialist |
| Date Prepared: | September 11, 2021 |
| Device Name | |
| Trade Name: | SeaSpine WaveForm™ C Interbody System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | |
| Class: | |
| Product Code: | Intervertebral fusion device with bone graft, cervical (21 CFR 888.3080) |
| II | |
| OVE, ODP |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K201073 | OVE, ODP | SeaSpine WaveForm™ C | |
| Interbody System | SeaSpine Orthopedics | ||
| Corporation | |||
| Additional Predicate Device | |||
| K161081 | OVE | SeaSpine Shoreline ACS System | SeaSpine Orthopedics |
| Corporation | |||
| K172676 | ODP | NuVasive Modulus-C Interbody | NuVasive, |
| Incorporated |
4
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K192582 | OVE | NuVasive CoRoent Small | |
| Interlock System | NuVasive, | ||
| Incorporated | |||
| K172064 | MAX | Ti-Diagon Oblique TLIF | Camber Spine |
| Technologies | |||
| K211258 | MAX, ODP, | ||
| OVD, OVE | Endoskeleton TC Interbody | ||
| System, Endoskeleton TCS | |||
| Interbody System, Endoskeleton | |||
| TA Interbody System, | |||
| Endoskeleton TAS & TAS Hyp | |||
| Interbody System, Endoskeleton | |||
| TL Interbody System, | |||
| Endoskeleton TL Hyp. Interbody | |||
| System, Endoskeleton TO | |||
| Interbody System, Endoskeleton | |||
| TT Interbody System |
Device Description
The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™ C Interbody System offers spacers in low profile (TruProfile) and no profile versions in various lengths and are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001.
The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.
Indications for Use
The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels, depending on the system. 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 WaveForm™ C Interbody System, the 2,3,4-hole TruProfile spacers and plates, are intended to be used as an adjunct to spinal fusion procedures
5
at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers.
When the WaveForm™ C Interbody (excluding 2-hole No-Profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).
Summary of Technological Characteristics
The WaveForm™ C Interbody System and predicate devices have the same operational principle; they act as a disc spacer and hold bone graft. The WaveForm™ C Interbody System is substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
The subject and predicate devices are based on the following similar technological elements:
- . Implant Spacer Heights
- Spacer Footprints
- . Spacer Lordotic Angles
- Screw Sizes and Lengths
Non-Clinical Testing
The WaveForm™ C Interbody System has been testing in accordance with requirements outlined in ASTM F2077, F2267, and F1877.
Conclusions
The submitted data demonstrates that the SeaSpine WaveForm™ C Interbody System performs at least as safely and effectively as the cited legally marketed predicate.