(148 days)
K172437 – CONSTRUX Mini PEEK Ti Spacer System – Orthofix Inc.
No
The summary describes a mechanical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for fixation of sacroiliac joint disruptions and sacroiliac joint fusion, which are therapeutic interventions.
No
The device is described as a surgical system for fixation and fusion of the sacroiliac joint, indicating it is an interventional or therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "multiple component system consisting of non-sterile instruments as well as sterile, 11mm and 12mm cannulated screws" made of titanium alloy. This clearly indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- SambaScrew Function: The SambaScrew 3D SI Fusion System is a surgical implant intended for the physical fixation and fusion of the sacroiliac joint. It is a mechanical device used within the body, not for testing samples outside the body.
- Device Description: The description clearly outlines a system of screws and instruments for surgical implantation.
- Intended Use: The intended use is for "fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion." This is a surgical procedure, not a diagnostic test.
The information provided describes a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The SambaScrew 3D SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended 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 SambaScrew 3D SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as sterile, 11mm and 12mm cannulated screws of various lengths featuring multiple fenestrations along the shaft. The 11mm cannulated screw features a tapered proximal end and dual-pitch threads while the 12mm cannulated screw features a single pitch thread on the proximal and distal ends. The SambaScrews are constructed from medicalgrade titanium alloy (Ti-6AI-4V ELI). The 11mm and 12mm SambaScrews are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. SambaScrew allows for packing of autograft and allograft materials.
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
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical testing consisting of Static and Dynamic cantilever beam Test, Static Torsion Test and Static Axial Pull-Off Test were conducted in accordance to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and in accordance to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.
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.
K121148 – SAMBA Screw System – Orthofix Inc., K151818 - Simmetry Sacroiliac Joint Fusion System – Zyga Technology, Inc., K182983 - iFuse Implant System – SI-Bone, Inc.
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.
K172437 – CONSTRUX Mini PEEK Ti Spacer System – Orthofix Inc.
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.
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April 30, 2019
Orthofix Inc. Ms. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K183342
Trade/Device Name: SambaScrew 3D SI 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: April 1, 2019 Received: April 2, 2019
Dear Ms. Koch:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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.
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)
Device Name SambaScrew 3D SI Fusion System
Indications for Use (Describe)
The SambaScrew 3D SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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) |
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510(k) SUMMARY
SambaScrew 3D SI Fusion System
| 510(k) Owner Information
Name:
Address: | Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214.937.2100
214-937-3322
jackikoch@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Senior Regulatory Affairs Specialist |
| Date Prepared: | April 1, 2019 |
| Name of Device
Trade Name / Proprietary
Name: | SambaScrew 3D SI Fusion System |
| Common Name: | Sacroiliac Joint Fixation Bone |
| Product Code: | OUR |
| Regulatory Classification: | Class II – 21 CFR § 888.3040 |
| Review Panel: | Orthopedic Device Panel |
| Primary Predicate Device: | K121148 – SAMBA Screw System – Orthofix Inc. |
| Additional Predicate
Devices: | K151818 - Simmetry Sacroiliac Joint Fusion System – Zyga
Technology, Inc.
K182983 - iFuse Implant System – SI-Bone, Inc. |
| Reference Devices: | K172437 – CONSTRUX Mini PEEK Ti Spacer System – Orthofix Inc. |
Reason for 510(k) Submission:
Orthofix is submitting this Traditional 510(k) premarket notification for the new SambaScrew 3D SI Fusion System.
Device Description
The SambaScrew 3D SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as sterile, 11mm and 12mm cannulated screws of various lengths featuring multiple fenestrations along the shaft. The 11mm cannulated screw features a
4
tapered proximal end and dual-pitch threads while the 12mm cannulated screw features a single pitch thread on the proximal and distal ends. The SambaScrews are constructed from medicalgrade titanium alloy (Ti-6AI-4V ELI). The 11mm and 12mm SambaScrews are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. SambaScrew allows for packing of autograft and allograft materials.
Indications for Use
The SambaScrew 3D SI Fusion System is intended for fixation of sacroillac joint disruptions, and intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the SambaScrew 3D SI Fusion System is similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the SambaScrew 3D SI Fusion System and the predicate devices which would adversely affect the use of the product.
PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Mechanical testing consisting of Static and Dynamic cantilever beam Test. Static Torsion Test and Static Axial Pull-Off Test were conducted in accordance to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and in accordance to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws.
| Subject Device | Mechanical Testing |
|---|---|
| SambaScrew 3D SI Fusion | |
| implants | Static cantilever beam test per ASTM F2193-18a Standard |
| Specifications and Test Methods for Components Used in the | |
| Surgical Fixation of the Spinal Skeletal System | |
| SambaScrew 3D SI Fusion | |
| implants | Dynamic cantilever beam test per ASTM F2193-18a Standard |
| Specifications and Test Methods for Components Used in the | |
| Surgical Fixation of the Spinal Skeletal System | |
| SambaScrew 3D SI Fusion | |
| implants | Static torsion test per ASTM F543-17, Standard Specification |
| and Test Methods for Metallic Medical Bone Screws | |
| SambaScrew 3D SI Fusion | |
| implants | Static axial pull-off test per ASTM F543-17 Standard |
| Specification and Test Methods for Metallic Medical Bone | |
| Screws |
Table 1: Mechanical Performance Testing
Basis of Substantial Equivalence
The new SambaScrew 3D SI Fusion System has the same intended use, the same indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate SAMBA Screw System (K121148), the Slmmentry Sacroiliac Joint Fusion System (K151818) and the iFuse Implant System (K162733).