(206 days)
No
The summary describes a mechanical fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for sacroiliac joint fusion, which treats a medical condition (sacroiliac joint disruptions and degenerative sacroiliitis) in skeletally mature patients.
No
The device is a sacroiliac joint fixation system consisting of screws designed to enhance fusion, not to diagnose conditions. Its intended use is for treatment (fusion), not diagnosis.
No
The device description explicitly states it consists of screws and describes various physical characteristics (diameters, lengths, screw types), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for sacroiliac joint fusion in skeletally mature patients. This is a surgical procedure to stabilize a joint within the body.
- Device Description: The device consists of screws designed to be implanted into the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is an implantable medical device used for surgical fixation, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannualated form to accommodate patient anatomy. The three design types of the subject device are:
-
- Standard Thread Screw (with and without slots)
-
- Lag Screw (with and without slots) and
-
- Washer Screw (with slots)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing
UNITY Sacroiliac Joint Fixation System contains the following contact metallic fastener screw and washer components: titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and Cobalt-Chromium-Molybdenum (CoCr) per ASTM F1537. The biocompatibility of the UNITY Sacroiliac Joint Fixation System is based on FDA's clearance of the Rexious Spinal Fixation System (K111362) that contains tissue contact materials for similar uses. The Biocompatibility Assessment for the Unity Sacroiliac Joint Fixation System demonstrates that the Unity Sacroiliac Joint Fixation System utilizes the same manufacturing processes, materials, sterilization and similar geometry for Huvexel's (formerly Dio Medical, Inc.) Rexious spinal fixation system (K111362), which provides the rationale for the UNITY Sacroiliac Joint Fixation System's sterilization and biocompatibility.
Mechanical Testing
Study Type: Three motion and stress tests were performed.
-
- Dynamic Cantilever Test,
-
- Static Cantilever Test.
-
- Static Axial Pullout Test, and
-
- Static Torsion Test.
Key Results: In all instances, the UNITY Sacroiliac Joint Fixation System functioned as intended and stability observed was as expected.
- Static Torsion Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/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 and 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.
April 26, 2018
Huvexel Co., Ltd. % Michael A. Patz, MBA, RAC Senior Regulatory/Quality Consultant ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K173201
Trade/Device Name: UNITY Sacroiliac Joint Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: March 28, 2018 Received: April 2, 2018
Dear Mr. Patz:
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 (QS) regulation (21 CFR Part 820);
1
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 -S
for 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) K173201
Device Name
UNITY Sacroiliac Joint Fixation System
Indications for Use (Describe)
The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| 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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K173201 Page1of3
Huvexel's UNITY Sacroiliac Joint Fixation System
I. SUBMITTER
Huvexel Co. Ltd. Rm. 101~105, Megacenter, Sktechnopark 124, Sagimakgol-lo, Jungwon-gu, Soengnam, Gyeonggi, South Korea TEL: + 82.31.776.3690 Fax: +82.31.776.3691
Contact Person: Sung Hee-Lee, Quality Management Representative and Deputy Manager of Huvexel Co., Ltd.
Date Prepared: September 28, 2017
II DEVICE
Name of Device: UNITY Sacroiliac Joint Fixation System
Common or Usual Name: Sacroiliac Joint Fixation Screw
Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Regulatory Class: II
Product Code: OUR
III PREDICATE DEVICE
Primary Predicate: Globus Medical - SI-LOK Sacroiliac Joint Fixation System (K112028)
Additional Predicates: Depuy-Synthes - Synthes Cannulated Screw System (K021932 & K962011)
IV DEVICE DESCRIPTION
The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannualated form to accommodate patient anatomy. The three design types of the subject device are:
-
- Standard Thread Screw (with and without slots)
-
- Lag Screw (with and without slots) and
4
-
- Washer Screw (with slots)
V INDICATIONS FOR USE
The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements:
- Consist of a screw and a washer ●
- Minimally invasive placement procedure .
- Device inserted percutaneously ●
- Use of a permanent implant for bone fixation ●
- Mechanically securing the fixation by a permanent implant screw .
There are no know technological differences between the subject and predicate devices other than the range of screw sizes offered.
VII PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
UNITY Sacroiliac Joint Fixation System contains the following contact metallic fastener screw and washer components: titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and Cobalt-Chromium-Molybdenum (CoCr) per ASTM F1537. The biocompatibility of the UNITY Sacroiliac Joint Fixation System is based on FDA's clearance of the Rexious Spinal Fixation System (K111362) that contains tissue contact materials for similar uses. The Biocompatibility Assessment for the Unity Sacroiliac Joint Fixation System demonstrates that the Unity Sacroiliac Joint Fixation System utilizes the same manufacturing processes, materials, sterilization and similar geometry for Huvexel's
5
(formerly Dio Medical, Inc.) Rexious spinal fixation system (K111362), which provides the rationale for the UNITY Sacroiliac Joint Fixation System's sterilization and biocompatibility.
Mechanical Testing
Three motion and stress tests were performed:
-
- Dynamic Cantilever Test,
-
- Static Cantilever Test.
-
- Static Axial Pullout Test, and
-
- Static Torsion Test.
Standards Applied
Performance Standard
ASTM F2193-14, Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System (Static and Dynamic Cantilever)
ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws (Static Axial Pullout and Static Torsion)
In all instances, the UNITY Sacroiliac Joint Fixation System functioned as intended and stability observed was as expected.
VIII CONCLUSIONS
The UNITY Sacroiliac Joint Fixation System is substantially equivalent to the Globus Medical- SI-LOK Sacroiliac Joint Fixation System (K112028), and the Depuy-Synthes -Synthes Cannulated Screw System (K021932 & K962011). The UNITY Sacroiliac Joint Fixation System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the UNITY Sacroiliac Joint Fixation System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the UNITY Sacroiliac Joint Fixation System is as substantially equivalent to the predicate devices.