(191 days)
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.
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 from 135mm 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.
This FDA 510(k) submission for the SIGNUS SACRONAIL® Transsacral Stabilization System does not contain information about acceptance criteria or a study proving the device meets those criteria in a traditional sense of clinical performance or diagnostic accuracy.
Instead, this submission is for a medical device (an implantable hardware system) where the primary focus for substantial equivalence is on mechanical performance, biocompatibility, and intended use comparison to predicate devices.
Therefore, I cannot populate most of the requested fields as they pertain to studies typically performed for diagnostic devices or AI algorithms.
Here's a breakdown of what can be extracted from the provided text, and where gaps exist based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (spinal implant), "acceptance criteria" are generally related to demonstrating mechanical equivalence to predicate devices and biocompatibility, rather than a clinical performance metric like sensitivity or specificity.
| Acceptance Criteria Category | Specific Criteria (Implied from testing) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Equivalence to predicate devices in mechanical properties relevant for its intended use (fixation of pelvic/sacral fractures). | "The detailed mechanical testing shows that in summary, the SACRONAIL® Transsacral System provides equivalent mechanical properties compared to the predicate for this intended use." (Section 10.2) |
| Biocompatibility | Meet ISO 10993 standards for implant devices with tissue/bone contact and permanent contact, using Ti6Al4V (ASTM F 136 / ISO 5832-3) with Type II anodization. | "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." (Section 10.1) |
| Material Composition | Use of recognized, safe medical-grade materials. | Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. (Section 8) |
| Intended Use | Match the intended use of predicate devices for fixation of posterior pelvic and sacral fractures. | "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." (Section 7, page 4) This matches the implied intended use of predicate "Sacral Bar" and "Cannulated Screws". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical performance or AI algorithm testing. Mechanical testing would involve specific numbers of test articles, but these are not analogous to a "test set" of patient data.
- Data Provenance: Not applicable for clinical/AI test sets. For mechanical testing, the articles are new devices and the comparative data would come from published standards or predicate device testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device's evaluation relies on mechanical and biocompatibility testing, not clinical "ground truth" derived from expert review of patient data.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a hardware device, not a diagnostic or AI-assisted system for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
- For mechanical testing: Engineering standards (e.g., ASTM F1264-16, ASTM F1717-15, ASTM F543) serve as the "ground truth" or benchmark for performance.
- For biocompatibility: ISO 10993 standards and established literature on medical-grade titanium alloy.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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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
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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
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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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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
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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 ofEquivalence for: | 510(k) holder | |||
| Sacral Bar | K001720 | Predicate Device | Depuy/Synthes |
| Additional Predicates | |||
|---|---|---|---|
| Trade Name | Clearance | Claim ofEquivalence for: | 510(k) holder |
| Dynanail MiniHybrid | K203381 | AdditionalPredicate Device | MedShape Inc. |
| 7.3 mm CannulatedScrews | K161616 | AdditionalPredicate Device | DePuy/Synthes |
| M.U.S.T. Sacral Iliacand Pelvic TraumaSystem | K171595 | AdditionalPredicate Device | MedactaInternational 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
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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.
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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
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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.
§ 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.