(144 days)
Not Found
No
The device description and performance studies focus on the physical properties and intended use of standard surgical pins and wires, with no mention of AI or ML.
Yes
The device, Steinmann Pins and Kirschner Wires, is used for stabilization and fixation of fractures, which are therapeutic interventions.
No
The device description and intended use clearly state that these devices are used for fracture stabilization, alignment, reduction, and fixation, which are therapeutic and surgical interventions, not diagnostic ones.
No
The device description explicitly states that the devices are made from stainless steel and are physical pins and wires used for skeletal traction and fracture fixation. This indicates a hardware-based medical 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 clearly describes the devices (Steinmann Pins and Kirschner Wires) as being used in vivo (within the body) for stabilizing and fixing bone fractures, skeletal traction, and as guide wires during surgical procedures.
- Device Description: The description details the physical characteristics of the pins and wires (material, dimensions, tip geometry) which are consistent with surgical implants and instruments used directly on 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) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for mechanical support and manipulation of bone.
N/A
Intended Use / Indications for Use
The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation. The Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.
• For use as guide wires in hip pinning procedures,
• For use in aligning and reducing long bone fractures,
• For use in securing temporary stabilization of bone fractures such as olecranon fractures; patella fractures; tibia plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures.
• For use with cerclage wire/cable in treating greater trochanter fractures.
Product codes (comma separated list FDA assigned to the subject device)
HTY, JDW
Device Description
The Steinmann Pins and Kirschner Wires are designed for multiple purposes which allow the use in skeletal traction for alignment and reduction of bone fractures, function as fracture fixation devices in certain fractures, preliminary fixation for implants (for example plates) and for evaluation of screw trajectories or guidance for cannulated instruments.
The Steinmann Pins and Kirschner Wires are available in different dimensions and provide several design features. The dimensions vary in diameter and length. The design features are the tip geometry which can be a three-sided trocar tip or a two-sided diamond tip on either one end or both ends of the pin. Additionally, some pins are threaded.
The pins and wires are made from stainless steel (1.4441).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, hip, olecranon, patella, tibia, hand, foot, humeral, radial, ulnar, greater trochanter
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:
The Steinmann Pins and Kirschner wires are single use instruments, sterilized by means of radiation; they are sterile stainless steel wires with diameter and lengths comparable to those of the predicate devices. The design is substantially equivalent to that of the predicate devices; the indications for use are included in those of the predicate devices; the material of the Steinmann Pins and Kirschner wire are the same as that of the predicate device. Moreover, Steinmann Pins and Kirschner wires conform to the international standard ISO 5838-1. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Steinmann Pins and Kirschner wires.
Packaging tests were performed according ISO 11607-1 and ISO 11607-2. All bench tests performed in accordance with ASTM standards.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to demonstrate substantial equivalence to the predicate devices.
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.
Apex Fixation Pins (K001886), Osteo Kirschner Wires (K971962)
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 5, 2021
Stryker GmbH Keith Neligan Senior Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K211508
Trade/Device Name: Steinmann Pins and Kirschner Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: August 18, 2021 Received: August 24, 2021
Dear Keith Neligan:
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
1
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 (OS) 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,
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211508
Device Name Steinmann Pins
Indications for Use (Describe)
The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
| 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."
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K211508
Device Name Kirschner Wires
Indications for Use (Describe)
The Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.
· For use as guide wires in hip pinning procedures,
· For use in aligning and reducing long bone fractures,
· For use in securing temporary stabilization of bone fractures such as olecranon fractures; tibia plateau fractures; hand and foot bone fractures; humeral, radial and ulnar fractures.
· For use with cerclage wire/cable in treating greater trochanter fractures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (Part 21 CFR 201 Subpart C) |
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(k) Summary
| Proprietary Names: | Steinmann Pins
Kirschner Wires |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Pin, Fixation, Threaded; Pin, Fixation, Smooth |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Classification Product Code: | JDW, HTY |
| Device Class: | II |
| Submitter: | Stryker GMBH
Bohnackerweg 1
2545 Selzach, Switzerland |
| Contact Person: | Keith Neligan
Senior Staff Regulatory Affairs Specialist
IDA Business & Technology Park, Carrigtwohill,
Co. Cork, Ireland T45 HX08
Phone: +00 353 87 7995645 |
| Date: | August 09, 2021 |
| Primary Predicate Device | Apex Fixation Pins (K001886) |
| Additional Predicate Device | Osteo Kirschner Wires (K971962) |
| Device Description: | The Steinmann Pins and Kirschner Wires are designed for multiple purposes
which allow the use in skeletal traction for alignment and reduction of bone
fractures, function as fracture fixation devices in certain fractures, preliminary
fixation for implants (for example plates) and for evaluation of screw
trajectories or guidance for cannulated instruments.
The Steinmann Pins and Kirschner Wires are available in different dimensions
and provide several design features. The dimensions vary in diameter and
length. The design features are the tip geometry which can be a three-sided
trocar tip or a two-sided diamond tip on either one end or both ends of the pin.
Additionally, some pins are threaded.
The pins and wires are made from stainless steel (1.4441). |
| Indications for Use: | The Steinmann Pins are intended to be used in conjunction with a compatible
Stryker external supporting frame for immobilization of open and/or unstable
fractures and where soft tissue injury may preclude the use of other fracture
treatments such as IM rodding, casting and other means of internal fixation. |
| | The Kirschner Wires are intended for use in skeletal traction for alignment and
reduction of long bone fractures, and as guide wires in hip pinning, and as
fracture fixation devices in certain other small bone fractures.
• For use as guide wires in hip pinning procedures,
• For use in aligning and reducing long bone fractures,
• For use in securing temporary stabilization of bone fractures such as
olecranon fractures; patella fractures; tibia plateau fractures; small hand and
foot bone fractures; humeral, radial and ulnar fractures.
• For use with cerclage wire/cable in treating greater trochanter fractures. |
| Summary of Technologies: | Steinmann Pins:
The intended use of the subject devices (Steinmann Pins) are similar to those
detailed in the predicate device (Apex Fixation Pins). There is no change in the
fundamental scientific technology shared by both the subject device and
predicate device. |
| | Kirschner Wires
The intended use of the subject devices (Kirschner Wires) are similar to those
detailed in the predicate device (Osteo Kirschner Wires). There is no change in the
fundamental scientific technology shared by both the subject device and
predicate device. |
| Performance Data (Nonclinical): | Non-Clinical Performance and Conclusions:
The Steinmann Pins and Kirschner wires are single use instruments, sterilized
by means of radiation; they are sterile stainless steel wires with diameter and
lengths comparable to those of the predicate devices. The design is
substantially equivalent to that of the predicate devices; the indications for use
are included in those of the predicate devices; the material of the Steinmann
Pins and Kirschner wire are the same as that of the predicate device. Moreover,
Steinmann Pins and Kirschner wires conform to the international standard ISO
5838-1. Testing, therefore, is not needed to demonstrate that the subject devices
are substantially equivalent to other legally marketed Steinmann Pins and
Kirschner wires. |
| | Packaging tests were performed according ISO 11607-1 and ISO 11607-2. All
bench tests performed in accordance with ASTM standards. |
| | Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to demonstrate
substantial equivalence to the predicate devices. |
| Conclusion: | The subject devices have the same intended use and similar indications for use
as the predicate devices. 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 devices.
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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