(103 days)
BioPro Go-EZ Screw (K081149)
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a hip system comprised of screws intended for fracture fixation, which is a structural support function rather than a therapeutic one.
No
Explanation: The device is a system of screws intended for fracture fixation, which is a therapeutic intervention, not a diagnostic process.
No
The device description explicitly states the system is comprised of "Cannulated and Cross Screws," which are physical hardware components. The performance studies also focus on testing these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The SimpliFix Hip System is a surgical implant used for fracture fixation of bones. It is a physical device implanted into the body to stabilize fractures.
The description clearly states its intended use is for "fracture fixation of large bone fragments" and describes it as a system of "Cannulated and Cross Screws." This is the definition of a surgical orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The SimpliFix Hip System is intended for fracture fixation of large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to a dynamic hip screw (DHS) in basilar neck fractures.
Product codes
HWC
Device Description
The SimpliFix Hip System is designed for angular and rotational stability when used for fracture fixation of large bones and large bone fragments such as femoral neck fractures, slipped capital epiphyses and an adjunct to DHS in basilar neck fractures.
The system is comprised of Cannulated and Cross Screws that are used together to aid fracture fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Dynamic screw construct testing
Screw performance testing per ASTM F543
Screw performance testing per ASTM F1264 .
Pyrogenicity testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes 6.5mm Cannulated Screw (K021932), Smith and Nephew Cannulated Screws and Washers (K111994)
Reference Device(s)
BioPro Go-EZ Screw (K081149)
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.
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.
April 19, 2023
Stabiliz Orthopaedics Inc. % Hollace Rhodes VP, Orthopedic Regulatory Affairs MCRA, LLC. 803 7th Street NW 3rd Floor Washington, District of Columbia 20000-1
Re: K230053
Trade/Device Name: SimpliFix Hip System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 31, 2023 Received: March 31, 2023
Dear Hollace Rhodes:
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.
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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 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.
Shumaya Ali-S
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230053
Device Name SimpliFix Hip System
Indications for Use (Describe)
The SimpliFix Hip System is intended for fracture fixation of large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to a dynamic hip screw (DHS) in basilar neck fractures.
| 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) |
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K230053 510(k) Summary
| Device Trade Name: | SimpliFix Hip System |
|---|---|
| Manufacturer: | Stabiliz Orthopaedics, Inc. |
| 600 Eagleview Blvd | |
| Unit 300 | |
| Exton, PA 19341 | |
| Contact: | Douglas L. Cerynik, MD |
| President & CEO | |
| Stabiliz Orthopaedics, Inc. | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | April 18, 2023 |
| Regulation: | 21 CFR 888.3040 |
| Class: | II |
| Product Codes: | HWC |
| Primary Predicate: | Synthes 6.5mm Cannulated Screw (K021932) |
| Additional Predicate: | Smith and Nephew Cannulated Screws and Washers (K111994) |
| Reference Device: | BioPro Go-EZ Screw (K081149) |
Indications For Use:
The SimpliFix Hip System is intended for fracture fixation of large bones and large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to a dynamic hip screw (DHS) in basilar neck fractures.
Device Description:
The SimpliFix Hip System is designed for angular and rotational stability when used for fracture fixation of large bones and large bone fragments such as femoral neck fractures, slipped capital femoral epiphyses and an adjunct to DHS in basilar neck fractures.
The system is comprised of Cannulated and Cross Screws that are used together to aid fracture fixation.
4
Discussion of Predicate & Reference Devices:
Stabiliz submits the following information in this premarket notification to demonstrate that, for the purposes of FDA's regulation of medical devices, SimpliFix Hip System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to predicate devices including the Synthes 6.5mm Cannulated Screw (K021932) and Smith and Nephew Cannulated Screws and Washers (K111994). A reference device, BioPro Go-EZ Screw (K081149), was used to support the biocompatibility of the SimpliFix Hip System based on comparable materials and manufacturing processes.
Performance Testing Summary:
The SimpliFix Hip System components have undergone the following testing to establish substantial equivalence to the predicate device.
- . Dynamic screw construct testing
- . Screw performance testing per ASTM F543
- Screw performance testing per ASTM F1264 .
- Pyrogenicity testing
Substantial Equivalence:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods.
Conclusion
The data included in this submission demonstrate the SimpliFix Hip System's substantial equivalence to the predicate device. SimpliFix Hip System is as safe, as effective, and performs as well as, or better, than the identified predicate device.