The SeaSpine Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions:

· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

Spondylolisthesis
· Trauma (i.e., fracture or dislocation)
· Spinal tumor

The SeaSpine Spinous Process System is intended for stand-alone use.

Device Description

The SeaSpine Spinous Process System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). The Spinous Process System consists of an implantable spacer featuring 2 plates (male and female) with a variable barrel width, fixed wing length, and fixed plate width, and set screws that clamp bilaterally to the spinous processes. Each plate contains spikes (teeth) for fixation to the spinous process to aid in resisting rotation, flexion, and extension after implantation. Implants are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient, and manufactured from Ti-6Al-4V ELI per ASTM F136.

AI/ML Overview

This document is a 510(k) Summary for the SeaSpine Spinous Process System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria and study results in the format requested.

Here's why and what information is missing:

No Acceptance Criteria Table or Reported Performance: The document states "The testing demonstrated substantially equivalent mechanical performance as compared to the predicate" but does not provide a table of specific acceptance criteria (e.g., minimum load to failure, specific range for displacement) or the actual numerical performance results of the SeaSpine device against those criteria. It only generally claims equivalence.
No Information on Sample Size, Data Provenance, or Experts for a Test Set: The non-clinical testing performed involved mechanical tests (static axial compression, static axial torsion, and dynamic axial compression bending tests). These tests use physical specimens (e.g., test constructs, simulated bone) rather than patient data or expert adjudicated datasets. Therefore, concepts like "sample size used for the test set," "data provenance," "number of experts," or "adjudication method" are not applicable in this context.
No Multi-Reader Multi-Case (MRMC) Study: The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means no MRMC study or any clinical study was conducted for this submission.
No Standalone Algorithm Performance: This is a mechanical orthopedic implant, not an AI/algorithm-driven device. Therefore, standalone algorithm performance is not applicable.
Type of Ground Truth: For mechanical testing, the "ground truth" would be established by the physical properties and behavior of the tested materials and constructs under controlled lab conditions, as measured by standard engineering instruments. It's not expert consensus, pathology, or outcomes data.
Training Set Information: This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing are based on established engineering principles and material science.
How Ground Truth for Training Set was Established: Not applicable as there is no training set.

Summary of available information as per your request:

Information Category	Report in Document
1. Acceptance Criteria & Reported Device Performance	The document states: "Static axial compression, static axial torsion, and dynamic axial compression bending tests were performed using methods based on ASTM F1717 and ASTM F2624. The testing demonstrated substantially equivalent mechanical performance as compared to the predicate." Missing: Specific numerical acceptance criteria (e.g., x N for static compression) and the exact performance values of the SeaSpine device. The document only provides a qualitative statement of "substantially equivalent."
2. Sample Size (Test Set) & Data Provenance	Not Applicable: The testing described is mechanical (non-clinical) using physical specimens, not patient data or images.
3. Number of Experts & Qualifications (Ground Truth for Test Set)	Not Applicable: Mechanical testing does not involve human experts establishing ground truth for a test set.
4. Adjudication Method (Test Set)	Not Applicable: Mechanical testing does not involve adjudication by experts.
5. MRMC Comparative Effectiveness Study & Effect Size (Human Readers with/without AI)	No: The document explicitly states: "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This device is a mechanical implant, not an AI system.
6. Standalone Algorithm Performance	No: This device is a mechanical implant, not an algorithm/AI.
7. Type of Ground Truth Used	For mechanical testing, the "ground truth" is derived from the objective measurements and controlled conditions of the laboratory tests based on established engineering standards (ASTM F1717 and ASTM F2624). This is physical/empirical data, not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set	Not Applicable: This device is a mechanical implant and does not involve AI or machine learning with a "training set."
9. How Ground Truth for the Training Set was Established	Not Applicable: This device is a mechanical implant and does not involve AI or machine learning with a "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 4, 2021

SeaSpine Orthopedics Corporation Gina Flores Sr. Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K173334

Trade/Device Name: SeaSpine Spinous Process System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK

Dear Gina Flores:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 22, 2018. Specifically, FDA is updating this SE Letter to correct the trade name in the Indications for Use Page and Indications for Use section of the 510(k) Summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Colin O'Neill, M.B.E., OHT6: Office of Orthopedic Devices, (301) 796-6428, colin.oneill@fda.hhs.gov.

Sincerely,

Colin O'neill -S

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

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Image /page/1/Picture/0 description: The image shows 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.

February 22, 2018

SeaSpine Orthopedics Corporation Ms. Gina Flores Senior Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K173334

Trade/Device Name: SeaSpine Spinous Process System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: January 26, 2018 Received: January 29, 2018

Dear Ms. Flores:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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Page 2 - Ms. Gina Flores

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173334

Device Name SeaSpine Spinous Process System

Indications for Use (Describe)

· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

· Spondylolisthesis
· Trauma (i.e., fracture or dislocation)
· Spinal tumor

The SeaSpine Spinous Process System is not intended for stand-alone use.

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)

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510(k) Summary

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(760) 216-5136
Fax number:	(760) 683-6874
Contact person:	Gina Flores, Sr. Regulatory Specialist
Email address:	gina.flores@seaspine.com
Date Prepared:	February 21, 2018
Device Name
Trade Name:	SeaSpine Spinous Process System
Common Name:	Spinous Process Plate
Classification Name:	Spinal Interlaminal Fixation Orthosis
Classification:	21 CFR 888.3050, Spinal Interlaminal Fixation Orthosis
Class:	II
Product Code:	PEK

Legally Marketed Predicate Device

510(k)Number	Product Code	Trade Name	Manufacturer
Primary Predicate
K121924	PEK	SeaSpine Spinous ProcessSystem	SeaSpineOrthopedicsCorporation
Additional Predicates
K071877,K121316	KWP, MNI	Aspen MIS Fixation System	Zimmer/Biomet(formerly Lanx, Inc.)
K141317	PEK	Aurora Spine ZIP FlaredSystem	Aurora Spine, Inc.

Device Description

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rotation, flexion, and extension after implantation. Implants are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient, and manufactured from Ti-6Al-4V ELI per ASTM F136.

Intended Use/Indications for Use

· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

Spondylolisthesis
· Trauma (i.e., fracture or dislocation)
· Spinal tumor

The SeaSpine Spinous Process System is intended for stand-alone use.

Summary of Technological Characteristics

The Spinous Process System and predicate device have the same operational principle; they are spacers that engage the spinous processes and provide fixation during fusion.

The SeaSpine Spinous Process 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 device are based on the following similar technological elements:

· Plate lengths
Plate widths
· Barrel lengths and widths
· Same implant materials, Titanium Alloy (6AL-4V ELI per ASTM F136)
· Utilize the same set screw

Non-Clinical Testing

Static axial compression, static axial torsion, and dynamic axial compression bending tests were performed using methods based on ASTM F1717 and ASTM F2624. The testing demonstrated substantially equivalent mechanical performance as compared to the predicate.

Clinical Testing

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

Conclusions

The submitted data demonstrate that the SeaSpine Spinous Process System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate devices.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.