Who is the manufacturer of Huvex Interspinous Fusion System?

Dio Medical Corp. filed the 510(k) submission for Huvex Interspinous Fusion System (K223790).

What is the FDA product code for Huvex Interspinous Fusion System?

PEK. It is classified under 21 CFR 888.3050 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Huvex Interspinous Fusion System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Huvex Interspinous Fusion System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Huvex Interspinous Fusion System

K223790 · Dio Medical Corp. · PEK · Mar 9, 2023 · Orthopedic

Device Facts

Record ID	K223790
Device Name	Huvex Interspinous Fusion System
Applicant	Dio Medical Corp.
Product Code	PEK · Orthopedic
Decision Date	Mar 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3050
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Huvex Interspinous Fusion System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the Huvex Interspinous Fusion System 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), and/or tumor. The Huvex Interspinous Fusion System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

Device Story

System comprises titanium alloy plates, pins, bolts, caps, center bars, and set screws; provides supplemental posterior fixation for lumbar spine fusion. Implanted by surgeons during spinal procedures; attaches to spinous processes to stabilize segment; used with autogenous bone graft to promote fusion. Device acts as mechanical support; does not function as stand-alone fixation. Benefits include stabilization of spinal segment in patients with degenerative conditions, trauma, or tumors.

Clinical Evidence

No clinical data or performance testing required; subject device is identical to the previously cleared predicate (K162849).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F 136. Components: Left/right plates, pin, bolt, inner cap, center bar, set screw. Form factor: Modular assembly for five size configurations. Fixation: Posterior, non-pedicle, interspinous. Sterilization: Supplied non-sterile. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients requiring single-level, posterior, non-pedicle supplemental lumbar (T1-S1) fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or tumor. Must be used with autogenous bone graft; not for stand-alone use.

Regulatory Classification

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.

Predicate Devices

Huvexel Co. Ltd. - Huvex Interspinous Fusion System (K162849)

Related Devices

K112592 — AXLE PEEK INTERSPINOUS FUSION SYSTEM · X-Spine Systems, Inc. · Dec 5, 2011
K962784 — ULTIUM SPINAL PLATING SYSTEM · Smith & Nephew, Inc., Orthopaedic Div. · Oct 2, 1996
K161016 — Z-Clamp ISP System · Zavation, LLC · Oct 19, 2016
K142378 — Interspinous Plate System · Precision Spine, Inc. · Dec 18, 2014
K102195 — SP-FIX SPINOUS PROCESS FIXATION PLATE · Globus Medical, Inc. · Jan 19, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ March 9, 2023 Image /page/0/Picture/1 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. Dio Medical Corp. Milan George VP of R&D 2100 Campus Lane, Suite 100 East Norriton, Pennsylvania 19403 # Re: K223790 Trade/Device Name: Huvex Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: March 2, 2023 Received: March 3, 2023 # Dear Milan George: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 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/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, 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 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) K223790 Device Name Huvex Interspinous Fusion System #### Indications for Use (Describe) The Huvex Interspinous Fusion System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the Huvex Interspinous Fusion System 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), and/or tumor. The Huvex Interspinous Fusion System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use. 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 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 FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ # 510(k) SUMMARY # Dio Medical Huvex Interspinous Fusion System | Sponsor: | Manufacturer: | Dio Medical Corp. 2100 Campus Lane, Suite 100 East Norriton, PA 19403 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | | Official Contact: | Milan George | | | Email: | mgeorge@dio-us.com | | | Phone: | 1-877-394-5407 ext.102 | | Date Prepared: | December 16, 2022 | | | Device Name: | Huvex Interspinous Fusion System | | | Common Name: | Spinous Process Plate | | | Classification Name: | Spinal interlaminal fixation orthosis | | | Classification Number: | 21 CFR 888.3050 | | | Product Code/Classification: | PEK, class II | | | Description: | The HUVEX Interspinous Fusion System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different HUVEX Interspinous Fusion implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The HUVEX Interspinous Fusion System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments | | | Indications For Use: | The Huvex Interspinous Fusion System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the Huvex Interspinous Fusion System 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), and/or tumor. The Huvex Interspinous Fusion System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use. | | | Predicate Device: | Primary predicate: Huvexel Co. Ltd. - Huvex Interspinous Fusion System (K162849) | | | Substantial Equivalence: | The Huvex Interspinous Fusion System is identical to the predicate device and is as safe and effective as the Huvexel - Huvex Interspinous Fusion System. The Subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. There are no technological differences between the Subject device and its predicate devices resulting in no new issues of safety or effectiveness. Thus, the Dio Medical- Huvex Interspinous Fusion System is identical/substantially equivalent to the predicates. | | | Performance Data: | The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K162849. No testing is required. | | | Conclusion: | The Dio Medical Huvex Interspinous Fusion System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Thus, the subject device is identical/substantially equivalent to the predicate device. | | are provided. Both implant and instruments have trays that are used for handling and storage. {4}------------------------------------------------