(104 days)
No
The device description and performance studies focus on mechanical properties and MRI compatibility of bone screws, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
This device is a therapeutic device because its intended use is for "fracture fixation," which directly treats a medical condition (fractures).
No
Explanation: The device is described as a "Cannulated Screw System" intended for "fracture fixation." It is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description clearly states that the device consists of physical components (screws and washers made of stainless steel and titanium alloy) intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of small and long bones and of the pelvis." This describes a surgical implant used in vivo (within the body) to stabilize fractures.
- Device Description: The description details physical components like screws and washers made of stainless steel and titanium alloy. These are mechanical devices, not reagents or instruments used to test biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device clearly falls under the category of a surgical implant for orthopedic use.
N/A
Intended Use / Indications for Use
The Asnis® III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
The Asnis® PRO Cannulated Screw System intended for fracture fixation of small and long bones and and of the pelvis. The system is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The Asnis® III Cannulated Screw System, previously cleared in K000080, K024060, consists of self-tapping cannulated screws and the corresponding washers. All devices in the system are provided sterile and non-sterile. The thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.
The Asnis® PRO Cannulated Screw System consists of self-tapping cannulated screws. All devices in the system are provided sterile and non-sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. Screws are made of stainless steel and titanium alloy.
The subject of this bundled traditional submission is to introduce minor design specification changes; MRI Labeling, shelf-life update of existing package to 10 years, and re-branding Ø6.5/8.0 mm long screws (130-180 mm to Asnis® PRO Cannulated Screw System) to the Asnis® III Cannulated Screw System, cleared in K000080 and K024060 and to introduce a new system Asnis® PRO Cannulated Screw System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones and of the pelvis
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)
Non-Clinical Performance and Conclusions: No mechanical testing was deemed necessary as the design modifications and the new system introduction do not create a new worst case. All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System (K024060), remain true and accurate. Tests performed to establish compatibility with a magnetic resonance environment: Magnetically Induced Displacement per ASTM F2052 Magnetically Induced Torque per ASTM F2213 RF Heating per ASTM F2182 Image Artifacts per ASTM F 2119.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
January 11, 2022
Stryker GmbH Danielle Jannuzzi Madureira Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K213199
Trade/Device Name: Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. HTN Dated: December 17, 2021 Received: December 20, 2021
Dear Danielle Jannuzzi Madureira:
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/cfpmp/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.
1
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) 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 medical devices and radiation-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.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K213199
Device Name Asnis® III Cannulated Screw System
Indications for Use (Describe)
The Asnis® III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
K213199
Device Name Asnis® PRO Cannulated Screw System
Indications for Use (Describe)
The Asnis® PRO Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510 K213199
510(k) Summary
| Proprietary Name: | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw
System |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Screw (primary)
Washer, Bolt Nut |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener (primary)
Single/multiple component metallic bone fixation appliances and accessories |
| Regulation Number: | 21 CFR 888.3040 (primary), 21 CFR 888.3030 |
| Classification Product Code: | HWC (primary), HTN |
| Device Class: | II |
| Sponsor: | Stryker GMBH
Bohnackerweg 1
2545 Selzach, Switzerland |
| Contact Person: | Danielle Jannuzzi Madureira, PhD
Staff Regulatory Affairs Specialist
Dr. Homer Stryker Strasse, 1
CH-2545 Selzach, Switzerland
Phone: +41 79 890 02 89
Fax: +41 32 641 66 60 |
| Date: | September 24, 2021 |
| Primary Predicate Device: | Asnis® III Cannulated Screw System (K000080) |
| Additional Predicate Device: | Biomet Cannulated Screw System (K140891) |
| Device Description: | The Asnis® III Cannulated Screw System, previously cleared in K000080,
K024060, consists of self-tapping cannulated screws and the corresponding
washers. All devices in the system are provided sterile and non-sterile. The
thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or
partially threaded. All screws are self-drilling and self-tapping. There are
corresponding washers to the 4.0 and 5.0 mm screws respectively and one
washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are
made of stainless steel and titanium alloy. |
| | The Asnis® PRO Cannulated Screw System consists of self-tapping
cannulated screws. All devices in the system are provided sterile and non-
sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or
partially threaded. All screws are self-drilling and self-tapping. Screws are
made of stainless steel and titanium alloy. |
| | The subject of this bundled traditional submission is to introduce minor
design specification changes; MRI Labeling, shelf-life update of existing
package to 10 years, and re-branding Ø6.5/8.0 mm long screws (130-180 mm
to Asnis® PRO Cannulated Screw System) to the Asnis® III Cannulated
Screw System, cleared in K000080 and K024060 and to introduce a new
system Asnis® PRO Cannulated Screw System. |
| Indications for Use: | The Asnis® III Cannulated Screw System intended for fracture fixation of
small and long bones and of the pelvis. The system is not intended for spinal
use.
The Asnis® PRO Cannulated Screw System intended for fracture fixation of
small and long bones and of the pelvis. The system is not intended for spinal
use. |
| Comparison to Predicate
Device: | The intended use of the modified devices, as described in its labeling, has not
changed because of the modifications proposed in the present submission.
The introduction of minor design specification changes, MRI Labeling, shelf-
life update of existing package to 10 years, nor re-branding Ø6.5/8.0 mm long
screws (130-180 mm) to Asnis® PRO Cannulated Screw System nor the new
system (Asnis® PRO Cannulated Screw System) introduction does not alter
the fundamental scientific technology shared by both the subject devices,
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw
System, and predicate device, Asnis® III Cannulated Screw System. |
| Performance Data (Nonclinical): | Non-Clinical Performance and Conclusions:
No mechanical testing was deemed necessary as the design modifications and
the new system introduction do not create a new worst case. All bench tests
performed in accordance with ASTM F543 and previously presented in
Asnis® III Cannulated Screw System (K024060), remain true and accurate.
Tests performed to establish compatibility with a magnetic resonance
environment:
Magnetically Induced Displacement per ASTM F2052 Magnetically Induced Torque per ASTM F2213 RF Heating per ASTM F2182 Image Artifacts per ASTM F 2119 |
| Clinical Performance and Conclusions: | Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. |
| Conclusion: | The subject devices have the same intended use and indications for use as the
predicate device. The subject devices use the same operating principle,
incorporate the same basic design and labeling and are manufactured and
sterilized using the same materials and processes as the predicate device.
Except for the modifications described in this submission the subject devices
are identical to the predicate device, and the performance data and analyses
demonstrate that:
any differences do not raise new questions of safety and |
5
- enectiveness as established with performance results; and
the subject devices are at least as safe and effective as the legally
marketed predicate devices •