← Product Code [OUR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR) · K102907 # SIMMETRY SACROILIAC JOINT FUSION SYSTEM (K102907) _Zyga Technology, Inc. · OUR · Dec 14, 2010 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K102907 ## Device Facts - **Applicant:** Zyga Technology, Inc. - **Product Code:** [OUR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR.md) - **Decision Date:** Dec 14, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The SImmetry Sacroiliac Joint Fusion System is intended for fixation of large bones, including: bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. ## Device Story SImmetry Sacroiliac Joint Fusion System consists of cannulated titanium alloy screws (6.5mm-12.5mm diameter; 30mm-70mm length). Device provides rigid fixation for pelvic bones; used for degenerative sacroiliitis and sacroiliac joint disruptions. Operates as mechanical bone fixation fastener; implanted by surgeons to stabilize sacroiliac joint. Output is physical stabilization of bone segments; aids in fusion process. Benefits patient by providing necessary rigidity to support healing of joint disruptions. ## Clinical Evidence Bench testing only. Mechanical performance data including axial pull-out strength, driving torque, static bend strength, and bending fatigue strength demonstrated equivalence to the K021932 predicate device. ## Technological Characteristics Manufactured from Titanium Alloy (Ti-6Al-4V ELI). Cannulated screw design; diameters 6.5mm-12.5mm; lengths 30mm-70mm. Mechanical fixation principle. No software or electronic components. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Synthes 6.5mm Cannulated Screw ([K021932](/device/K021932.md)) - SIJF Cannulated Screw System ([K051296](/device/K051296.md)) - SI Joint Fusion System ([K092375](/device/K092375.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}------------------------------------------------ K102907 Image /page/0/Picture/1 description: The image shows the logo for Zyga Technology, Inc. The logo features a stylized letter Z on the left, followed by the company name in a bold, sans-serif font. The words "Technology" is underlined, and "Inc." is abbreviated with a period. DEC 1 4 2010 ﺒﻴﺮ... a 1/2 ph (612) 455-1061 fax (612) 455-1529 700 10th Avenue South, Suite 400 Minneapolis, Minnesota 55415 ### 510(k) Summary and Certification ## [As required by 21 CFR 807.92(c)] # 1. Submitter / Contact Person / Date of Preparation | Submitter | Zyga Technology, Inc.
700 10th Ave South, Suite 400
Minneapolis, MN 55415-1745 | |---------------------|--------------------------------------------------------------------------------------------| | Contact Person | Diane Brinza
Director of Reg/Clin/QA
Ph. 612.455.1061, ext. 104
Fax. 612.455.1064 | | Date of Preparation | September 30, 2010 | ## 2. General Information | Trade Name | SImmetry™ Sacroiliac Joint Fusion System | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common / Usual
Name | Fixation device/ Bone Screw | | Classification Name | Smooth or threaded metallic bone fixation fastener | | Classification | Class II (per 21 CFR § 888.3040) | | Manufacturer | Zyga Technology, Inc.
700 10th Ave South, Suite 400
Minneapolis, MN 55415-1745 | | Identification of
Predicate Devices | K021932
Synthes (USA)
Synthes 6.5mm Cannulated Screw
K051296
DePuy Spine, Inc.
SIJF Cannulated Screw System
K092375
SI-Bone, Inc.
SI Joint Fusion System | | Device Description | The SImmetry Sacroiliac Joint Fusion System consists
of cannulated screws available in titanium having
diameters ranging from 6.5mm-12.5mm; and lengths
of 30mm-70mm. | | Intended Use /
Indications for Use | The SImmetry Sacroiliac Joint Fusion System is
intended for fixation of large bones, including: bones of
the pelvis, for conditions including degenerative
sacroiliitis and sacroiliac joint disruptions. | | Technological
Characteristic | The principle of operation of the subject devices is
identical to that of the identified predicates. A review
of the test data for the subject devices indicates that | Page 1 of 2 {1}------------------------------------------------ k102907 | | they are equivalent to predicate devices that are
currently commercially marketed. The subject devices
are capable of withstanding expected loading without | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | failure. | | Materials | The subject devices are manufactured from Titanium
Alloy (Ti-6Al-4V ELI). | | Technological
Comparison | The SImmetry Sacroiliac Joint Fusion System
technological characteristics do not raise any new
questions of safety or effectiveness. Performance data
measured against the K021932 Synthes 6.5mm
Cannulated Screw predicate device demonstrates that
the SImmetry Sacroiliac Joint Fusion System is as safe
and effective as predicate devices. | | Summary of
Non-clinical
Performance Data | Results for mechanical testing for axial pull out
strength, driving torque, static bend strength and
bending fatigue strength demonstrates the
SImmetry Sacroiliac Joint Fusion System is
substantially equivalent with respect to mechanical
performance of the K021932 Synthes 6.5mm
Cannulated Screw predicate device. Also, the test
results establish that the SImmetry Sacroiliac Joint
Fusion System provides the necessary rigidity to
support the intended use. | | Conclusion | Equivalence for the SImmetry Sacroiliac Joint Fusion
System is based on the similarity in indications for use,
design features, operational principles, and material
composition and mechanical performance when
compared to the predicate devices cleared under the
following submissions:
K021932 Synthes 6.5mm Cannulated Screw K051296 DePuy 6.5mm and 8.0mm SIJF
Cannulated Screw System K092375 SI Joint Fusion System | Page 2 of z {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its wings are angled upwards. The logo is simple and clean, and it is easily recognizable. APR - 7 2011 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zyga Technology, Inc. % Ms. Diane Brinza Director of Regulatory, Clinical and Ouality Assurance 700 10th Avenue South, Suite 400 Minneapolis, Minnesota 55415 Re: K102907 Trade/Device Name: SImmetryTM Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: December 3, 2010 Received: December 6, 2010 Dear Ms. Brinza: This letter corrects our substantially equivalent letter of December 14, 2010. 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. {3}------------------------------------------------ Page 2 - Ms. Diane Brinza 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 device-related 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours, Alig B. R. to for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT 510(k) Number (if known): 102907 Device Name: SImmetry™ Sacroiliac Joint Fusion System Indications For Use: The SImmetry™ Sacroiliac Joint Fusion System|is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. Over-The-Counter Use _ Prescription Use __ V_________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THISS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) for U. Melleprom (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K102907 Page of lof --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K102907](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K102907) **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