(76 days)
Not Found
No
The summary describes a mechanical orthopaedic screw and does not mention any software, algorithms, or AI/ML capabilities.
No.
A therapeutic device is one that treats a disease or condition. This device is a screw used for fixation during ligament reconstruction, which is a surgical procedure, but the screw itself is not directly therapeutic; it's a fixation device.
No
The device description clearly states "The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures." This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description explicitly states the device is a screw composed of medical grade titanium alloy, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the Quick-Start Orthopaedic Screws are "interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures." This is a device that is surgically implanted within the body to provide structural support.
- Intended Use: The intended use is for surgical procedures to reconstruct ligaments, which is an in-vivo (within the body) application.
The device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Quick-Start Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction such as anterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
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 MR safety testing has been completed on the Quick-Start Screw. Tests for displacement force and torque effects, heating effects and image artifacts were conducted on three sizes of Quick-Start Screw, in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", dated May 20, 2021 and ASTM F2052-21, ASTM F2213-17, ASTM F2182-19 and ASTM F2119-07(2013).
Results of the testing confirmed that the risk of displacement force or torque effects during clinical MR scanning is considered low and acceptable. Results also established the potential temperature increase and image artefact during clinical MR scanning and demonstrate the safety of the Quick-Start Screws in the MR environment within the conditions specified in the Instructions for Use.
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.
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September 5, 2023
Image /page/0/Picture/1 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, 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.
Innovate Orthopaedics Limited Mike Bilson QA/RA Manager The Globe, Bridge Street, Slaithwaite Huddersfield, HD7 5JN United Kingdom
Re: K231819
Trade/Device Name: Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 19, 2023 Received: June 21, 2023
Dear Mike Bilson:
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,
Jesse Muir -S
Jesse Muir, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231819
Device Name
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Indications for Use (Describe)
Quick-Start Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction such as anterior cruciate ligament (ACLPCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
Type of Use (Select one or both, as applicable)
| ü Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
K231819
Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Date Prepared: June 19, 2023
Submitter Information
| Submitter: | Innovate Orthopaedics Limited |
|---|---|
| Address: | The Globe, Bridge Street, Slaithwaite |
| HD7 5JN, United Kingdom | |
| Contact: | Mike Bilson |
| Telephone: | +44 (0) 1484 796796 |
| Email: | mike.bilson@innovateortho.co.uk |
Device Information
| Trade Name: | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw |
|---|---|
| Common Name: | Screw, Fixation, Bone, Orthopedics |
| Classification: | Class II |
| Regulation: | 21 CFR 888.3040 |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Classification Panel: | Orthopedics |
| Product Code: | HWC |
Predicate Information
| Trade Name: | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw |
|---|---|
| Common Name: | Screw, Fixation, Bone, Orthopedics |
| Classification: | Class II |
| Regulation: | 21 CFR 888.3040 |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Classification Panel: | Orthopedics |
| Product Code: | HWC |
| 510(k) Number: | K212547 |
Purpose of Submission
This traditional premarket notification is submitted to obtain clearance for the modified Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw, which includes the modification to include MR conditional labelling.
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Predicate Device Information
The predicate Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for interference fixation of soft tissue grafts and/or bone-tendonbone grafts for ligament reconstruction. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs. This is identical to the proposed device.
Device Description
The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.
Accessory Descriptions
The Innovate Orthopaedics Quick-Start Guide-Wire accessory is composed of medical grade nickel-titanium alloy and is supplied sterile for single use. The Guidewire is 1.8mm in diameter and 250mm in length.
The Innovate Orthopaedics Quick-Start 3.5 Hex Cannulated Screwdriver is composed of a highgrade stainless-steel shaft with a silicon rubber soft-grip handle. The screwdriver is supplied nonsterile and is cleaned and sterilized at the customer facility.
Intended Use
The Quick-Start Orthopaedic Fixation Screw/Reverse Thread Screw are indicated for interference fixation of Bone-Tendon-Bone or soft tissue grafts in ligament reconstruction.
Indications for Use
Quick-Start Orthopaedic Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
Technological Characteristics
The Technological characteristics of the modified Quick-Start Orthopaedic Fixation Screws are unchanged from the previously cleared Quick-Start Orthopaedic Fixation Screws (K212547):
The following are the key technological characteristics of the devices:
- Manufactured from Titanium Ti6-AL4-V ELI alloy per ASTM F-136. ●
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- The driver interface of 3.5 mm hex. ●
- Cannulated for use with guide wire accessories. ●
- Variable, or graduated, lead in thread to ease insertion. ●
- The head has a flat beveled edge head profile with a thread starter marker. ●
Comparison of Principles of Operation & Technological Characteristics
The modified Quick-Start Screws and original Quick-Start Screws have the same intended use, indications, technological characteristics and principal of operation.
Performance Data
The Ouick-Start screws did not require clinical study data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes:
- Indications for Use
- Technological characteristics
- Non-clinical performance testing including MR Safety testing
Non-clinical MR safety testing has been completed on the Quick-Start Screw. Tests for displacement force and torque effects, heating effects and image artifacts were conducted on three sizes of Quick-Start Screw, in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", dated May 20, 2021 and ASTM F2052-21, ASTM F2213-17, ASTM F2182-19 and ASTM F2119-07(2013).
Results of the testing confirmed that the risk of displacement force or torque effects during clinical MR scanning is considered low and acceptable. Results also established the potential temperature increase and image artefact during clinical MR scanning and demonstrate the safety of the Quick-Start Screws in the MR environment within the conditions specified in the Instructions for Use.
The addition of MR conditional labelling does not raise different questions of safety or effectiveness.
Conclusion
Based on the indications for use, technological characteristics, and the summary of data submitted. Innovate Orthopaedics has determined that the modified Ouick-Start Orthopaedic Fixation Screws are substantially equivalent to the currently marketed predicate device. The Quick-Start Orthopaedic Fixation Screws continue to perform as well as the predicate device.