(139 days)
Not Found
No
The summary describes a mechanical interference screw for ligament reconstruction and does not mention any AI or ML components or functionalities.
Yes
The device is described as an "interference screw" used for the "fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction," which means it is intended to treat a condition or disease (ligament damage) by providing structural support and facilitating healing, thus qualifying as a therapeutic device.
No
Explanation: The device is an interference screw used for securing soft tissue grafts in ligament reconstruction, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's health status.
No
The device description explicitly states the device is composed of "medical grade titanium alloy," indicating it is a physical 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 clearly states the device is for "interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction." This is a surgical procedure performed in vivo (within the body) to physically fix tissues.
- Device Description: The device is described as an "interference screw" made of titanium alloy, used for "fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures." This further reinforces its role as a surgical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any such tests on biological samples in vitro.
The information provided describes a surgical implant used for mechanical fixation during reconstructive surgery, which falls under the category of a surgical device, not an IVD.
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/posterior cruciate ligament (ACLPCL), medial 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 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 (ACLPCL), medial 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)
A comparative biophysical performance study of the Quick-Start Screws compared to a legally marketed device was carried out using 10 fresh-frozen human cadaveric knees. The Quick-Start Screw was found to be easier to engage with the bone tunnel and initially insert than the comparative device while still achieving similar immediate postsurgical fixation strength. This study provides objective evidence that the subject device is substantially equivalent to a legally marketed predicate.
Testing according to the applicable ASTM standards demonstrated that the Quick-Start Orthopaedic Fixation Screws meet the performance based requirements outlined by the FDA including torsional strength (ASTM F543), driving torque (ASTM F543), axial pullout strength. This testing demonstrates the subject device is as safe and effective as currently marketed screws.
The Quick Start Screws were analyzed for endotoxin using the Limulus Amebocyte Lysate (LAL) test. Testing demonstrates that the subject devices meet the acceptance criteria at 20 endotoxin units per device in accordance with USP for medical devices which are not in contact with cerebrospinal fluid.
The Quick Start Screws were determined to be biocompatible per International standard: ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing and FDA Guidance Document: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1": Evaluation and Testing within a risk management process issued September 4, 2020, the Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screws are categorized as an implant device with permanent contact (>30 days) to tissue or bone.
The devices are supplied sterile for single-use. The Quick Start screws are provided sterile (SAL 10-6) by means of Co60 gamma irradiation. The Quick Start Screws have a 5 year shelf life.
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.
0
December 30, 2021
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 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 Alex Gutteridge Managing Director 3M Buckley Innovation Centre Firth Street Huddersfield, HD1 3BD United Kingdom
Re: K212547
Trade/Device Name: Quick-Start Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 11, 2021 Received: August 13, 2021
Dear Alex Gutteridge:
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,
for
Laura C. Rose, 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K212547
Device Name Quick-Start Screws
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/posterior cruciate ligament (ACLPCL), medial collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
| and and the mail of the mail one in the mail and the mail one the mail of the mail of the bases of the bases of the first of the first of the first of the first of the first
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
Innovate Orthopaedics Quick-Start Screw
Date Prepared: August 11, 2021
Submitter Information
| Submitter: | Innovate Orthopaedics Limited |
|---|---|
| Address: | 3M Buckley Innovation Centre |
| Firth Street, Huddersfield, HD1 3BD | |
| Contact: | Alex Gutteridge |
| Telephone: | +44 (0) 1484 505869 |
| Email: | alex.gutteridge@innovateortho.co.uk |
Device Information
| Trade Name: | Quick-Start Screws |
|---|---|
| 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 |
Purpose of Submission
This traditional premarket notification is submitted to obtain initial clearance for the Quick-Start Screw and Reverse Thread Screw. This is a new device to the United States market.
Predicate Device Information
The Quick-Start Screw and Reverse Thread Screw described in this submission are substantially equivalent to the following predicate device: Smith & Nephew, Inc. RCI Fixation Screws (K992945).
Device Description
The Innovate Orthopaedics Quick-Start 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
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The Innovate Orthopaedics Quick-Start Guide-Wire accessory is composed of medical grade nickel-titanium alloy and is supplied sterile for single use.
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 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 Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendonbone 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.
Comparison of Principles of Operation & Technological Characteristics
The Quick-Start device family and RCI Fixation Screws have the same intended use and principal of operation. The proposed and predicate devices have similar indications for use; the minor differences in indications for use do not constitute a new intended use for the device. The Quick-Start device family and RCI Fixation Screws have similar technological characteristics, differences include: variable pitch on the lead-in taper, flat beveled edge on screw head, and a wider range of screw sizes. The minor differences between the proposed and predicate devices do not raise different questions of safety or effectiveness and are therefore substantially equivalent.
Performance Data
A comparative biophysical performance study of the Quick-Start Screws compared to a legally marketed device was carried out using 10 fresh-frozen human cadaveric knees. The Quick-Start Screw was found to be easier to engage with the bone tunnel and initially insert than the comparative device while still achieving similar immediate postsurgical fixation strength. This study provides objective evidence that the subject device is substantially equivalent to a legally marketed predicate.
Testing according to the applicable ASTM standards demonstrated that the Quick-Start Orthopaedic Fixation Screws meet the performance based requirements outlined by the FDA including torsional strength (ASTM F543), driving torque (ASTM F543), axial pullout strength. This testing demonstrates the subject device is as safe and effective as currently marketed screws.
The Quick Start Screws were analyzed for endotoxin using the Limulus Amebocyte Lysate (LAL) test. Testing demonstrates that the subject devices meet the acceptance criteria at 20 endotoxin
5
units per device in accordance with USP for medical devices which are not in contact with cerebrospinal fluid.
The Quick Start Screws were determined to be biocompatible per International standard: ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing and FDA Guidance Document: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1": Evaluation and Testing within a risk management process issued September 4, 2020, the Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screws are categorized as an implant device with permanent contact (>30 days) to tissue or bone.
The devices are supplied sterile for single-use. The Quick Start screws are provided sterile (SAL 10-6) by means of Co60 gamma irradiation. The Quick Start Screws have a 5 year shelf life.
Conclusion
Based on the indications for use, technological characteristics, and the summary of data submitted, Innovate Orthopaedics has determined that the proposed Quick-Start Orthopaedic Fixation Screws are substantially equivalent to the currently marketed predicate device.