(391 days)
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for use in "bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation," which are therapeutic applications.
No
The device description and intended use clearly state that it is an orthopedic implant system designed for fracture and osteotomy fixation, not for diagnosing conditions.
No
The device description clearly states it is an orthopedic implant system consisting of a threaded bone fastener and washer, made of titanium alloy and nickel-titanium, which are hardware components.
Based on the provided information, the MedShape DynaFuse Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as an orthopedic implant system consisting of a threaded bone fastener and washer, made of titanium alloy and nickel-titanium. This is a physical implant used to stabilize bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The description of the DynaFuse Fixation System does not involve any such specimen analysis.
Therefore, the MedShape DynaFuse Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Product codes
HWC, HTN
Device Description
The proposed MedShape DynaFuse Fixation System is a sterile, single use orthopedic implant system consisting of a threaded bone fastener and washer. The DynaFuse Fixation System is designed to apply compression across a target fracture or fusion site and is intended to be used for fracture and osteotomy fixation, including joint arthrodesis. The devices provided sterile, intended for single use, and are comprised of titanium alloy and nickel-titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones
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)
The following non-clinical tests were performed to demonstrate substantial equivalence to the predicate devices:
- Static Torsion Test per ASTM F543
- Static Strain Test per ASTM F2516
- Fatigue Strain Test per ASTM E606
- Bacterial endotoxin testing based on an endotoxin limit of 20EU/device per ANSI/AAMI ST72:2011
Additional engineering analysis of the MedShape DynaFuse Fixation System and the predicate devices was also performed to demonstrate substantial equivalence.
No new questions of safety or effectiveness were identified during device testing and analysis; therefore, the DynaFuse Fixation System is considered substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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January 4, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
MedShape, Inc. Ryan O'flaherty Product Manager 1575 Northside Drive NW, Suite 440 Atlanta, Georgia 30318
Re: K203595
Trade/Device Name: DynaFuse Fixation 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: November 29, 2021 Received: December 1, 2021
Dear Ryan O'flaherty:
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
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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
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Indications for Use
510(k) Number (if known) K203595
Device Name DynaFuse Fixation System
Indications for Use (Describe)
The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Type of Use (Select one or both, as applicable)
| Registration Use (Part 81 CFR 801.2 Subpart D) | |
|---|---|
| Over-The-Counter Use (81 CFR 801.3 Subpart E) |
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 shows the MedShape logo. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape is a combination of a square and a circle. The word "MEDSHAPE" is written in a sans-serif font, and there is a trademark symbol after the word.
510(k) Summary
510(k) Number: K203595
D.
December 7th, 2020 Date Submitted:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Ryan O'Flaherty Product Manager (404) 249-9155 (404) 249-9158 (fax) ryan.oflaherty@medshape.com
- C. Device Information: DynaFuse™ Fixation System Trade Name: Common Name: Smooth or threaded metallic bone fixation fastener
- Device Classification: Class II 21 CFR 888.3040 (Primary) Smooth or threaded metallic bone fixation fastener Panel Code: 87, Orthopedic Panel Product Code: HWC
Class II 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories Panel Code: 87, Orthopedic Panel Product Code: HTN
- E. Predicate Devices: Trilliant Surgical Tiger Cannulated Screw, K153338 (Primary) Tyber Medical Trauma Screw, K133842 and K153575
- F. Referenced Predicate Devices: MedShape DynaNail Mini, K182677
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G. Physical Description:
The proposed MedShape DynaFuse Fixation System is a sterile, single use orthopedic implant system consisting of a threaded bone fastener and washer. The DynaFuse Fixation System is designed to apply compression across a target fracture or fusion site and is intended to be used for fracture and osteotomy fixation, including joint arthrodesis. The devices provided sterile, intended for single use, and are comprised of titanium alloy and nickel-titanium.
H. Indications for Use:
The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
-
l. Comparison of Characteristics / Performance Testing / Substantial Equivalence: The MedShape DynaFuse Fixation system and its predicate devices have similar indications for use, design, materials, and technological principles of operation.
The following non-clinical tests were performed to demonstrate substantial equivalence to the predicate devices: -
Static Torsion Test per ASTM F543
-
Static Strain Test per ASTM F2516
-
Fatigue Strain Test per ASTM E606
-
Bacterial endotoxin testing based on an endotoxin limit of 20EU/device per ANSI/AAMI ST72:2011
Additional engineering analysis of the MedShape DynaFuse Fixation System and the predicate devices was also performed to demonstrate substantial equivalence.
No new questions of safety or effectiveness were identified during device testing and analysis; therefore, the DynaFuse Fixation System is considered substantially equivalent to the predicate devices.
RET
Ryan O'Flaherty Product Manager (404) 249-9155 (404) 249-9158 (fax) ryan.oflaherty@medshape.com
Image /page/4/Picture/15 description: The image shows the logo for MedShape. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape appears to be a combination of a square and a circle, with the square positioned above the circle.