← Product Code [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX) · K201755 # WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System (K201755) _SeaSpine Orthopedics Corporation · MAX · Dec 15, 2020 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K201755 ## Device Facts - **Applicant:** SeaSpine Orthopedics Corporation - **Product Code:** [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX.md) - **Decision Date:** Dec 15, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The SeaSpine WaveForm™ L System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical, cancellous and/or corticocancellous bone, Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine WaveForm™ L System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm™ L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis. The SeaSpine WaveForm™ L System is intended for use with supplemental fixation. When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation. ## Device Story Additively manufactured intervertebral body fusion devices; includes straight (WaveForm L, WaveForm TO) and curved (WaveForm TA) cages; features large central graft windows for autogenous or allogeneic bone graft packing. Used in spinal fusion procedures to provide structural support and facilitate fusion; implanted by surgeons in clinical settings. Requires supplemental fixation. Benefits include stabilization of spinal segments in patients with DDD or spondylolisthesis; reduces pain by promoting fusion. Instruments provided for placement, adjustment, and removal. ## Clinical Evidence Bench testing only. Mechanical performance demonstrated equivalent to predicate systems per ASTM F2077, ASTM F2267, and ASTM F1877. ## Technological Characteristics Material: Ti-6Al-4V ELI titanium alloy (ASTM F3001). Manufacturing: Additive manufacturing. Form factor: Straight (L, TO) and curved (TA) interbody cages. Sterilization: Provided sterile. Energy source: None (mechanical). Connectivity: None. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - SeaSpine Spacer System - Pacifica ([K082310](/device/K082310.md)) - NuVasive Modulus XLIF Interbody System ([K163230](/device/K163230.md)) - SeaSpine Regatta Lateral System ([K181079](/device/K181079.md)) - SeaSpine Beachside System ([K192132](/device/K192132.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 15, 2020 SeaSpine Orthopedics Corporation Aly Alvarez Assoc. Manager, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008 Re: K201755 Trade/Device Name: WaveForm™ L Interbody System, WaveForm™ TO Interbody System, WaveForm™ TA Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: November 11, 2020 Received: November 12, 2020 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. {1}------------------------------------------------ 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 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 (QS) 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use # 510(k) Number (if known) #### K201755 Device Name SeaSpine WaveForm™ L Interbody System #### Indications for Use (Describe) The SeaSpine WaveForm™ L System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical, cancellous and/or corticocancellous bone, Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine WaveForm™ L System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm™ L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis. The SeaSpine WaveForm™ L System is intended for use with supplemental fixation. | Type of Use (Select one or both, as applicable) | | | |-------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------| | | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ Form Approved. OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use #### 510(k) Number (if known) K201755 Device Name SeaSpine WaveForm™ TO Interbody System #### Indications for Use (Describe) When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {4}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) #### K201755 Device Name SeaSpine WaveForm™ TA Interbody System #### Indications for Use (Describe) When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation. 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) PSC Publishing Services (301) 443-6740 EP #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {5}------------------------------------------------ # 510(k) Summary # K201755 ## Contact Details | Applicant Name: | SeaSpine Orthopedics Corporation | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Address:
Phone number:
Fax number: | 5770 Armada Drive, Carlsbad CA
(619) 884-4342
(760) 683-6874 | | Contact person: | Aly Alvarez, Assoc. Manager | | Date Prepared: | June 25, 2020 | | Device Name | | | Trade Name: | 1. SeaSpine WaveForm™ L Interbody System
2. SeaSpine WaveForm™ TO Interbody System
3. SeaSpine WaveForm™ TA Interbody System | | Common Name: | Intervertebral Body Fusion Device | | Classification Name: | Intervertebral Body Fusion Device (21 CFR 888.3080) | | Class: | II | | Product Code: | MAX, PHM | ## Legally Marketed Predicate Devices | 510(k) Number | Product Code | Trade Name | Manufacturer | |------------------------------|--------------|-------------------------------------------|----------------------------------------------------------------| | Primary Predicate Device | | | | | K082310 | MAX, MQP | SeaSpine Spacer System -
Pacifica | SeaSpine Orthopedics
Corporation (formerly
Theken Spine) | | Additional Predicate Devices | | | | | K163230 | MAX, PHM | NuVasive Modulus XLIF
Interbody System | NuVasive,
Incorporated | {6}------------------------------------------------ | K181079 | MAX | SeaSpine Regatta Lateral
System | SeaSpine Orthopedics
Corporation | |---------|-----|------------------------------------------------|-------------------------------------| | K192132 | MAX | SeaSpine Beachside System
(TLIF-O & TLIF-A) | SeaSpine Orthopedics
Corporation | ## Device Description The Seaspine WaveForm™ Lumbar Systems are additively manufactured intervertebral fusion devices with large 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. WaveForm™Lumbar System includes 3 different implants: - A straight, rectangular-shaped cage, intended for lateral surgical placements, and referred . to as WaveForm™ L - . A straight, rectangular-shaped cage, intended for posterior and transforaminal surgical placements, and referred to as WaveForm™ TO, and - A curved, banana-shaped cage, intended for transforaminal surgical placements, and ● referred to as WaveForm™ TA, and The implants are manufactured from Ti-6AI-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. 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 ## WaveForm™ LInterbody System The SeaSpine WaveForm™ L System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cortical cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operativetreatment prior to being treated with the device. The SeaSpine WaveForm™ L System is intended for use as an adjunct to fusion in the thoracolumbarspine from T1 to T12 and at the thoracolumbar iunction(T12-L1). for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm™L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. The SeaSpine WaveForm™ L System is intended for use with supplemental fixation. {7}------------------------------------------------ ## WaveForm™ TO Interbody System When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusionspinal surgery at the involved spinal level(s). These patients should havehad six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation. ## WaveForm™ TA Interbody System When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusionspinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation. ## Summary of Technological Characteristics The SeaSpine WaveForm™ Lumbar Systems are 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, etc.) and performance (mechanical safety). The implants 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 SeaSpine WaveForm™ Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077. ASTM F2267, and ASTM F1877. ## Conclusions The submitted data demonstrates that the SeaSpine WaveForm™ Lumbar Systems perform at least as safely and effectively as the cited legally marketed predicate. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K201755](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K201755) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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