← Product Code MRW · K163374 # ALLY™ Facet Screws (K163374) _Providence Medical Technology, Inc. · MRW · Feb 16, 2017 · OR · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K163374 ## Device Facts - **Applicant:** Providence Medical Technology, Inc. - **Product Code:** MRW - **Decision Date:** Feb 16, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OR - **Attributes:** Therapeutic ## Intended Use The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: and 4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radios and/ or (b) degenerative disease of the facets with instability. The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion. ## Device Story ALLY™ Facet Screws are permanent orthopedic implants providing mechanical support and temporary stabilization as an adjunct to spinal fusion. Implants are manufactured from Titanium-6AL-4V ELI and are available in various diameters and lengths. Used in posterior spinal surgery, the screws are inserted by surgeons to stabilize the spine until biologic fusion occurs. The device is supplied sterile and is for single-use only. The screws feature self-drilling and self-tapping designs, available in fully threaded and lag versions. By providing structural stability, the device aims to alleviate symptoms associated with spinal instability, fractures, or degenerative conditions. ## Clinical Evidence Bench testing only. Performed static and dynamic cantilever bending, static torsion, static pull-out, and drive torque testing per ASTM F2193-14 and ASTM F543-13. Pyrogenicity testing conducted per USP <85> with an endotoxin limit of <20EU/Device. Results met all acceptance criteria and exceeded those of the predicate device. ## Technological Characteristics Material: Titanium-6AL-4V ELI (ASTM F136). Design: Fully threaded and lag versions; self-drilling and self-tapping. Form factor: Various diameters and lengths. Sterilization: Sterile, single-use. No software or electronic components. ## Predicate Devices - SpartanS3 Facet System ([K092568](/device/K092568.md)) - Venus Facet Screw System ([K120340](/device/K120340.md)) - Facet Fixx ([K131417](/device/K131417.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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 16, 2017 Providence Medical Technology, Inc. Mr. Edward Liou Chief Operating Officer 1331 North California Boulevard, Suite 320 Walnut Creek, California 94596 Re: K163374 Trade/Device Name: ALLYTM Facet Screws Regulatory Class: Unclassified Product Code: MRW Dated: January 17, 2017 Received: January 19, 2017 Dear Mr. Liou: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163374 Device Name ALLY™ Facet Screws #### Indications for Use (Describe) The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: and 4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radios and/ or (b) degenerative disease of the facets with instability. The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion. Type of Use (Select one or both, as applicable) | X Prescription Use (Part 21 CER 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." {3}------------------------------------------------ #### 510(k) SUMMARY #### Providence Medical Technology, Inc.'s ALLY™ Facet Screws | Date Prepared: | February 8, 2017 | |------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Company: | Providence Medical Technology, Inc.
1331 N. California Blvd., Suite 320
Walnut Creek, CA 94596 | | Contact Person: | Edward Liou
Phone: 415.923.9376
Facsimile: 415.923.9377 | | Trade Name: | ALLY™ Facet Screws | | Common Name: | Facet screw | | Classification
Name: | System, Facet Screw Spinal Device | | Product Code,
Class: | MRW, Unclassified | | Predicate Devices: | | | Primary Predicate: SpartanS3 Facet System (K092568, cleared 11/17/09)
(This device has not been subject to recall.) | | | Additional Predicates: | Venus Facet Screw System (K120340, cleared 10/19/12)
Facet Fixx (K131417, cleared 7/12/13) | #### Indications for Use: The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: - 1) Trauma, including spinal fractures and/or dislocations; - 2) Spondylolisthesis; - 3) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; - 4) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient {4}------------------------------------------------ history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability. The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion. ### Device Description The ALLY™ Facet Screws are permanent implant devices manufactured from Titanium-6AL-4V ELI. The device is available in a variety of diameters and lengths to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The device is supplied sterile and single-use only. #### Technological Characteristics. The ALLY™ Facet Screws have technical characteristics similar to the predicate devices. See table below for a comparison of technical attributes. | Technological Characteristics | | |----------------------------------------------------------------|-----------------------------------------------| | ALLY™ Facet Screws
(Subject Device) | Spartan S³ Facet System
(Predicate Device) | | Single use only implant | Same | | Supplied sterile, individually packaged | Same | | Implant material is 6Al-4V Titanium conforming to
ASTM F136 | Same | | Fully threaded and lag versions | Same | | Self-drilling and self-tapping | Same | ### Performance Testing The following testing was performed using the subject device and results were compared to those of the predicate device: # Static and Dynamic Cantilever Bending - ASTM F2193-14 Standard Specifications and Test Methods for Components ● Used in the Surgical Fixation of the Spinal Skeletal System #### Static Torsion Testing {5}------------------------------------------------ - ASTM F543-13 Standard Specification and Test Methods for Metallic Medical ● Bone Screws ## Static Pull-Out Testing - · ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws ### Drive Torque ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws In addition, the following testing was performed: # Pyrogenicity Testing - · Pyrogenicity Testing was conducted in compliance with the FDA Guidance Documents listed below: - "Submission and Review of Sterility Information in Premarket O Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff" - "Pyrogen and Endotoxins Testing: Questions and Answers" O - Bacterial endotoxin testing (BET) as specified in USP <85> is used for o pyrogenicity testing to achieve the Endotoxin limit of <20EU/Device. In all instances, the ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results of the ALLY™ Facet Screws exceeded those of the predicate Spartan S Facet System. Therefore, the performance characteristics of the ALLYIM Facet Screws are substantially equivalent to those of the Spartan S Facet System. ### Substantial Equivalence The ALLY™ Facet Screws (subject device) are substantially equivalent to the Spartan S Facet System (predicate device cleared under K092568). When compared to the predicate device, the ALLYTM Facet Screws have the same: - indication for use; - implant material (Ti 6Al-4V ELI); - o design characteristics (fully threaded and lag versions); - o operating principle; and - o insertion method (via posterior spine). {6}------------------------------------------------ The subject devices are offered in a larger size range than that of the predicate device however, the ALLY™ Facet Screws are offered in the same size range as that of the reference devices. In addition, the Spartan S Facet System is cannulated while the ALLY™ Facet Screws are not. This difference does not affect the outer thread features of the subject device and thus the functional differences between the two devices are considered very minor. These minor differences between the ALLY™ Facet Screws and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the ALLY™ Facet Screws are substantially equivalent to the Spartan S3 Facet System. --- **Source:** [https://fda.innolitics.com/device/K163374](https://fda.innolitics.com/device/K163374) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com