(127 days)
No
The device description and performance studies focus on the mechanical properties and materials of the screws and washers, with no mention of AI or ML capabilities.
Yes
The device is described as "Cannulated Screws" intended for fixations, osteotomies, non-unions, malunions, fracture fixation, and fusions, which are all therapeutic interventions.
No
Explanation: The device is a cannulated screw system intended for fixation of bones, not for diagnosing conditions or diseases.
No
The device description explicitly states that the device consists of physical components (cannulated screws and washers made of stainless steel and titanium alloy).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation, fusion, osteotomies, non-unions, and malunions of bones. This is a surgical intervention directly on the patient's body.
- Device Description: The device is described as cannulated screws and washers made of stainless steel and titanium alloy. These are physical implants used in surgery.
- 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 fixation.
N/A
Intended Use / Indications for Use
The Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixations, osteotomies, non-unions, and malunions of fragments of small and long bones, the pelvis and bones of the foot.
The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for:
· fracture fixation, fusions, osteotomies, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot
· sacroiliac joint fusion for conditions including sacroiliac joint disruptions
The Asnis PRO 6.5 and 8.0 mm Cannulated Screws are intended for:
· fracture fixation, fusions, osteotomies, nonunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot
· sacroiliac joint fusion for conditions including sacroiliac joint disruptions
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN, OUR
Device Description
The Asnis® III Cannulated Screw System, previously cleared in K213199, 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. 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 subject of this bundled traditional submission is to clarify the indications to the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System, cleared in K213199 and to introduce a new washer to the Asnis® PRO Cannulated Screw System cleared in K213199.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones, the pelvis and bones of the foot, sacrum, 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)
Non-Clinical Performance and Conclusions: No mechanical testing was deemed necessary as the new washers does not create a new worst case. All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199), remain true and accurate. Static Cantilever Bending Test was performed according to ASTM F2193.
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.
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199)
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.
DePuy Synthes Trauma Screws (K192745)
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
June 10, 2022
Stryker GmbH Danielle Madureira, PhD Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K220319
Trade/Device Name: Asnis® III Cannulated Screw System, 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, OUR Dated: May 6, 2022 Received: May 9, 2022
Dear Dr. 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/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.
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, M.P.H. 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
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Indications for Use
510(k) Number (if known)
K220319
Device Name Asnis® III Cannulated Screw System
Indications for Use (Describe)
The Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixations, osteotomies, non-unions, and malunions of fragments of small and long bones, the pelvis and bones of the foot.
The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for:
· fracture fixation, fusions, osteotomies, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot
· sacroiliac joint fusion for conditions including sacroiliac joint disruptions
| 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."
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Indications for Use
510(k) Number (if known) K220319
Device Name Asnis® PRO Cannulated Screw System
Indications for Use (Describe)
The Asnis PRO 6.5 and 8.0 mm Cannulated Screws are intended for:
· fracture fixation, fusions, osteotomies, nonunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot
· sacroiliac joint fusion for conditions including sacroiliac joint disruptions
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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."
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510(k) Summary
| Proprietary Name: | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw
System |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Screw (primary)
Washer, Bolt Nut
Sacroiliac Joint Fixation |
| 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, OUR |
| Device Class: | II |
| Sponsor: | Stryker GMBH
Bohnackerweg 1
2545 Selzach, Switzerland |
| Contact Person: | Danielle Jannuzzi Madureira, PhD
Associate Manager Regulatory Affairs
Dr. Homer Stryker Strasse, 1
CH-2545 Selzach, Switzerland
Phone: +41 79 890 02 89
Fax: +41 32 641 66 60 |
| Date: | June 02, 2022 |
| Primary Predicate Device: | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw
System (K213199) |
| Additional Predicate Device | DePuy Synthes Trauma Screws (K192745) |
| Device Description: | The Asnis® III Cannulated Screw System, previously cleared in K213199,
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. 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 subject of this bundled traditional submission is to clarify the indications
to the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated |
| | Screw System, cleared in K213199 and to introduce a new washer to the
Asnis® PRO Cannulated Screw System cleared in K213199. |
| Indications for Use: | The Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixation of
fractures, fusions, osteotomies, non-unions, and malunions of fragments of
small and long bones, the pelvis and bones of the foot.
The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for:
fracture fixation, fusions, osteotomies, nonunions, and malunions of
fragments of small and long bones, the pelvis, sacrum, and bones of
the foot sacroiliac joint fusion for conditions including sacroiliac joint
disruptions The Asnis PRO 6.5 and 8.0 mm Cannulated Screws are intended for: fracture fixation, fusions, osteotomies, nonunions, and malunions of
fragments of small and long bones, the pelvis, sacrum, and bones of
the foot sacroiliac joint fusion for conditions including sacroiliac joint
disruptions |
| 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 clarification of the indication for use and the introduction of new washers
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 and Asnis® PRO Cannulated Screw System. |
| Performance Data (Nonclinical): | Non-Clinical Performance and Conclusions:
No mechanical testing was deemed necessary as the new washers does not
create a new worst case. All bench tests performed in accordance with ASTM
F543 and previously presented in Asnis® III Cannulated Screw System and
Asnis® PRO Cannulated Screw System (K213199), remain true and
accurate. Static Cantilever Bending Test was performed according to ASTM
F2193.
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. |
| 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
effectiveness as established with performance testing; and the subject devices are at least as safe and effective as the legally
marketed predicate devices |
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