(191 days)
Not Found
No
The device description focuses on mechanical components and materials for fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is intended for fracture fixation and stabilization, which aligns with surgical intervention rather than therapeutic treatment.
No
The device, SIGNUS SACRONAIL® Transsacral Stabilization System, is an implantable system intended for the fixation of fractures. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical components made of titanium alloy, including a nail, locking screws, and caps, along with specific surgical instruments for implantation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures in the posterior pelvis, sacrum, and sacro-iliac joint. This is a surgical procedure involving the implantation of a device to stabilize bone.
- Device Description: The device is a physical implant (nail and screws) made of titanium alloy, designed for surgical insertion into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The SIGNUS SACRONAIL® Transsacral Stabilization System is intended for fixation of fractures of the posterior pelvis, in areas of superior posterior inferior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
Product codes
HWC, JDS
Device Description
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage.
The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488.
There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior pelvis, superior iliac spine, posterior inferior illac spine, sacral, sacro-iliac joint
Indicated Patient Age Range
Not Found
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)
There are no clinical data generated and held by the manufacturer, i.e., no pre-marketing or post-market clinical studies or animal studies have been performed. The following information is provided in support of substantial equivalence.
Biocompatibility: The SACRONAIL® Transsacral Stabilization System is classified as an implant device with tissue/bone contact and permanent contact. Therefore, according to ISO 10993-1 the biological evaluation was assessed for potential effects. The SACRONAIL® Transsacral Stabilization System is manufactured from Titanium Alloy per ASTM F136. The evaluation was based on product-specific tests and on published literature data. This approach is considered feasible as Titanium Alloy is a wellestablished material in the medical field. The available data from the raw material manufacturer, the testing performed on the finished device, and published literature form the basis of the biological evaluation for the SACRONAIL® Transsacral Stabilization System. The presented results in this submission show that pedicle screw systems made from Titanium Alloy per ASTM F136 have a high demonstrable biological safety. No concerns arose that would preclude clinical use of SACRONAIL® Transsacral Stabilization System. The requirements of the ISO 10993 standard series are fulfilled.
Mechanical Testing: Testing according to ASTM F1264-16 Standard Specification and Test Method for Intramedullary Fixation Devices, ASTM F1717-15: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws was performed to demonstrate equivalence to predicates. The detailed mechanical testing shows that in summary, the SACRONAIL® Transsacral Stabilization System provides equivalent mechanical properties compared to the predicate for this intended use.
MR Safety Testing: The SACRONAIL® Transsacral Stabilization System has not been evaluated for safety, heating, migration, or compatibility in the MR environment. The SACRONAIL® Transsacral Stabilization System has not been tested for heating, migration or image artefact in the MR environment. The safety of the SACRONAIL® Transsacral Stabilization System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001720, K203381, K161616, K171595
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 10, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
SIGNUS Medizintechnik GmbH % Carolyn Guthrie Director of Regulatory & Quality Kapstone Medical, LLC 520 Elliot St. Charlotte, North Carolina 28202
Re: K212755
Trade/Device Name: SACRONAIL Transsacral Stabilization System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, JDS Dated: February 7, 2022 Received: February 9, 2022
Dear Carolyn Guthrie:
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 mediation-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, 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
Indications for Use
510(k) Number (if known) K212755
Device Name
SIGNUS SACRONAIL® Transsacral Stabilization System
Indications for Use (Describe)
The SIGNUS SACRONAIL® Transsacral Stabilization System is intended for fixation of fractures of the posterior pelvis, in areas of superior posterior inferior inferior iliac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
| 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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3
Image /page/3/Picture/1 description: The image is a logo for SIGNUS, a company that specializes in spine care. The logo features a stylized spine in gray and red, with the company name in bold, black letters. Below the company name is the tagline "The Spine Sign" in a smaller font, with a thin red line above and below it. The logo is simple and modern, and it effectively communicates the company's focus on spine care.
Traditional 510(k) Submission SIGNUS SACRONAIL® Transsacral Stabilization System
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.
1. Date of Preparation:
October 07, 2021
2. Applicant
SIGNUS Medizintechnik GmbH Industriestrasse 2 63755 Alzenau, Germany
3. Official Correspondent
Kapstone Medical LLC 520 Elliot St. Charlotte, NC 28202
4. Contact Person:
Carolyn Guthrie Email: cguthrie@kapstonemedical.com
5. Device Name
Trade Name: SIGNUS SACRONAIL® Transsacral Stabilization System Common Name: Pelvic Joint Fixation Regulation Description: Smooth or Threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040, 21 CFR 888.3030 Product Code: HWC Secondary Product Code: JDS Classification: Class II Panel: Orthopedic
4
Image /page/4/Picture/1 description: The image is a logo for SIGNUS - The Spine Sign. The logo features a stylized graphic on the left, consisting of a gray pill shape with a red triangle on either side. To the right of the graphic is the word "SIGNUS" in large, bold, black letters, with the tagline "The Spine Sign" in smaller letters underneath, separated by a thin red line.
Traditional 510(k) Submission SIGNUS SACRONAIL® Transsacral Stabilization System
6. Predicate Devices
| Primary Predicate | ||||||
|---|---|---|---|---|---|---|
| Trade Name | Clearance | Claim of | ||||
| Equivalence for: | 510(k) holder | |||||
| Sacral Bar | K001720 | Predicate Device | Depuy/Synthes |
| Additional Predicates | |||
|---|---|---|---|
| Trade Name | Clearance | Claim of | |
| Equivalence for: | 510(k) holder | ||
| Dynanail Mini | |||
| Hybrid | K203381 | Additional | |
| Predicate Device | MedShape Inc. | ||
| 7.3 mm Cannulated | |||
| Screws | K161616 | Additional | |
| Predicate Device | DePuy/Synthes | ||
| M.U.S.T. Sacral Iliac | |||
| and Pelvic Trauma | |||
| System | K171595 | Additional | |
| Predicate Device | Medacta | ||
| International SA |
Table 5.1: Predicate devices
7. Indications for Use
The SIGNUS SACRONAIL® Transsacral Stabilization System is intended for fixation of fractures of the posterior pelvis, in areas of superior iliac spine and posterior inferior illac spine, for sacral fractures and fracture-dislocations of the sacro-iliac joint.
8. Device Description
The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage.
The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to
5
K212755 - Page 3 of 5
Image /page/5/Picture/1 description: The image contains the logo for SIGNUS. The logo consists of a stylized shape in red and gray on the left, followed by the word "SIGNUS" in bold, black letters. Below "SIGNUS" is the tagline "The Spine Sign" in a smaller font, underlined by a thin red line.
Traditional 510(k) Submission SIGNUS SACRONAIL® Transsacral Stabilization System
the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488.
There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
8.1 Product Name
SIGNUS SACRONAIL® Transsacral Stabilization System
Intended Performance 8.2
The SACRONAIL system is intended to a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage.
6
Image /page/6/Picture/1 description: The image is a logo for SIGNUS - The Spine Sign. The logo consists of a stylized gray and red shape on the left, followed by the word "SIGNUS" in bold, black letters. Below "SIGNUS" is the phrase "The Spine Sign" in a smaller font, underlined with a thin red line.
9. Comparison of Technological Characteristics with the Predicate Devices
The subject device SACRONAIL® Transsacral Stabilization System was shown to be substantially equivalent and have the same technological characteristics to a previously FDA cleared predicate device through comparison in areas including, intended use, material composition, and function through the means of mechanical and biomechanical cadaveric comparison. Any technical differences, which were identified and discussed in this submission, do not result in new questions of safety or effectiveness.
10. Performance Data
There are no clinical data generated and held by the manufacturer, i.e., no pre-marketing or post-market clinical studies or animal studies have been performed. The following information is provided in support of substantial equivalence.
10.1 Biocompatibility
The SACRONAIL® Transsacral Stabilization System is classified as an implant device with tissue/bone contact and permanent contact. Therefore, according to ISO 10993-1 the biological evaluation was assessed for potential effects.
The SACRONAIL® Transsacral Stabilization System is manufactured from Titanium Alloy per ASTM F136. The evaluation was based on product-specific tests and on published literature data. This approach is considered feasible as Titanium Alloy is a wellestablished material in the medical field.
The available data from the raw material manufacturer, the testing performed on the finished device, and published literature form the basis of the biological evaluation for the SACRONAIL® Transsacral Stabilization System.
The presented results in this submission show that pedicle screw systems made from Titanium Alloy per ASTM F136 have a high demonstrable biological safety. No concerns arose that would preclude clinical use of SACRONAIL® Transsacral Stabilization System. The requirements of the ISO 10993 standard series are fulfilled.
10.2 Mechanical Testing
Testing according to
- ASTM F1264-16 Standard Specification and Test Method for Intramedullary . Fixation Devices
- . ASTM F1717-15: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- . ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
7
Image /page/7/Picture/1 description: The image is a logo for SIGNUS. The logo consists of a stylized pill shape in gray and red on the left, followed by the word "SIGNUS" in bold, black letters. Below the word "SIGNUS" are two horizontal red lines, and below the lines is the phrase "The Spine Sign" in a smaller font.
Traditional 510(k) Submission SIGNUS SACRONAIL® Transsacral Stabilization System
was performed to demonstrate equivalence to predicates.
The detailed mechanical testing shows that in summary, the SACRONAIL® Transsacral System provides equivalent mechanical properties compared to Stabilization the predicate for this intended use.
10.3 MR Safety Testing
The SACRONAIL® Transsacral Stabilization System has not been evaluated for safety, heating, migration, or compatibility in the MR environment. The SACRONAIL® Transsacral Stabilization System has not been tested for heating, migration or image artefact in the MR environment. The safety of the SACRONAIL® Transsacral Stabilization System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
11 Conclusion
The SIGNUS SACRONAIL® Transsacral Stabilization System and the predicate device have the similar intended use in sacral and pelvic fractures and are available by prescription only. The SACRONAIL System implants are provided sterile (Instruments are provided non-Sterile). Any technical differences, which were identified, do not result in new questions of safety or effectiveness.
Through assessment of technological characteristics, intended use and the biomechanical performance data provided, it can be concluded that SIGNUS SACRONAIL® Transsacral Stabilization System is substantially equivalent to the predicate device for this intended use.