(168 days)
No
The device description and performance studies focus on the mechanical properties and fixation strength of a titanium screw for ligament reconstruction, with no mention of AI or ML technologies.
Yes.
The device is used for interference fixation of grafts in ligament reconstruction, which is a therapeutic intervention aimed at restoring function and treating damaged ligaments.
No
The device description clearly states it is an "interference screw indicated for the fixation of grafts in ligament reconstruction procedures." It is a surgical implant, not a device used to diagnose medical conditions.
No
The device description clearly states the device is composed of medical grade titanium alloy and includes physical accessories like a guidewire and screwdriver, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of grafts in ligament reconstruction procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an interference screw made of titanium alloy, used to physically secure grafts during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on biological samples to provide information about a person's health. This device is a surgical implant used to physically repair damaged ligaments.
N/A
Intended Use / Indications for Use
Quick-Start Screws are indicated for interference fixation of 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.
Product codes
HWC
Device Description
The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of grafts in ligament reconstruction procedures such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions. 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 non-sterile and is cleaned and sterilized at the customer facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 subject device is identical to the currently legally marketed Quick-Start Screws, in physical form therefore the bench testing submitted in previous 510(k)s (K231819 & K212547), remains applicable to the subject device.
Bench testing applicable to the additional provision for use in fixation of synthetic grafts is included in the current submission. Fixation strength testing of various sizes of synthetic grafts with the Quick-Start Screws was performed. This demonstrated sufficient fixation strength to meet the minimum clinical requirement for the intended function of the intended function of the synthetic qrafts are as a reinforcement of the soft tissues repaired by suture or other fixation devices.
The bench testing performed supports the conclusion that the Quick-Start Screws may be used effectively to fixate synthetic grafts within the device indications, and such use does not introduce any new questions of safety or performance and the Quick-Start Screws with this provision are as safe and effective as the currently legally marketed Quick-Start Screws.
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.
0
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January 31, 2025
Innovate Orthopaedics Ltd Mike Bilson QA/RA Manager The Globe Bridge Street Slaithwaite, Huddersfield, West HD7 5JN United Kingdom
Re: K242442
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: August 12, 2024 Received: August 16, 2024
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Thomas Mcnamara -S
For: Christopher Ferreira, M.S. 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
Indications for Use (Describe)
Quick-Start Screws are indicated for interference fixation of 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.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| 510(k) #: | K242442 | 510(k) Summary | Prepared on: | 2025-01-03 |
|---|---|---|---|---|
| ----------- | --------- | ---------------- | -------------- | ------------ |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Innovate Orthopaedics Ltd |
| Applicant Address | The Globe Bridge Street Slaithwaite, Huddersfield West Yorkshire HD7 5JN United Kingdom |
| Applicant Contact Telephone | 01484 796796 |
| Applicant Contact | Mr. Mike Bilson |
| Applicant Contact Email | mike.bilson@innovateortho.co.uk |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Classification Name | Screw, Fixation, Bone |
| Regulation Number | 888.3040 |
| Product Code(s) | HWC |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K231819 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Scr | HWC |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of grafts in ligament reconstruction procedures such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions. 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 non-sterile and is cleaned and sterilized at the customer facility.
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
|---|---|
| ---------------------------------- | --------------------- |
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Quick-Start Screws are indicated for interference fixation of grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
The subject device indications are as follows:
Quick-Start Screws are indicated for interference fixation of grafts for ligament reconstruction such as anterior posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
The indications for the predicate device are as follows:
Quick-Start Screws are indicated for interference fixation of soft tissue grafts and/or bone grafts for ligament reconstruction such as anterior/posterior cruciate ligament (MCL), lateral collateral (MCL), lateral collateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
The only difference in indications for the subject device compared to the predicate device, is to remove mention of specific grafts as these are not applicable to an indication statement. There is no actual change in device indications.
Therefore the change in wording for the subject device is considered to be as the predicate device.
Technological Comparison
The Technological characteristics of the subject device are unchanged from the previously cleared Quick-Start Orthopaedic Fixation Screws (K231819):
The following are the key technological characteristics of the devices:
-
· Manufactured from Titanium Ti6-AL4-V ELI alloy per ASTM F-136.
· The driver interface of 3.5 mm hex. -
· Cannulated for use with quide 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.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The subject device is identical to the currently legally marketed Quick-Start Screws, in physical form therefore the bench testing submitted in previous 510(k)s (K231819 & K212547), remains applicable to the subject device.
Bench testing applicable to the additional provision for use in fixation of synthetic grafts is included in the current submission. Fixation strength testing of various sizes of synthetic grafts with the Quick-Start Screws was performed. This demonstrated sufficient fixation strength to meet the minimum clinical requirement for the intended function of the intended function of the synthetic qrafts are as a reinforcement of the soft tissues repaired by suture or other fixation devices.
The bench testing performed supports the conclusion that the Quick-Start Screws may be used effectively to fixate synthetic grafts within the device indications, and such use does not introduce any new questions of safety or performance and the Quick-Start Screws with this provision are as safe and effective as the currently legally marketed Quick-Start Screws.