(80 days)
Not Found
No
The 510(k) summary describes a system of bone screws and instrumentation, focusing on mechanical properties and intended use for orthopedic fixation. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device is a screw system used for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions, and fractures, which are all therapeutic interventions.
No
The device is a screw system used for stabilization and fixation of bones, which is a treatment method, not a diagnostic one.
No
The device description explicitly states it includes screws manufactured from Titanium Alloy and non-sterile, single use instrumentation necessary to implant the screws. This indicates it is a hardware-based medical 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Medline UNITE® MIS Foot Recon Screw System is a system of screws and instruments designed for the stabilization and fixation of bone in the foot and ankle. It is an implantable device used directly in the body during surgery.
- Intended Use: The intended use clearly states its purpose is for bone reconstruction, osteotomies, joint fusions, and fractures. This is a structural and mechanical function within the body, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, this device is a surgical implant and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medline UNITE® MIS Foot Recon Screw System is indicated for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions (arthrodeses), and fractures of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle. Screws are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Medline UNITE® MIS Foot Recon Screw System includes screws manufactured from Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 or IOS 5832-3. The screws are offered in various diameters from 2.5mm up to 4.0mm and overall lengths ranging from 14mm up to 70mm. The screws are single use and provided non-sterile intended to be cleaned and steam sterilized prior to use. The system also includes non-sterile, single use instrumentation necessary to implant the screws, e.g. drill bits and countersinks. Validated cleaning and sterilization instructions are included in the instructions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle (tarsals, metatarsals, phalanges, distal tibia and fibula)
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 Medline UNITE® MIS Foot Recon Screw System was evaluated through an engineering analysis and non-clinical testing for torsional yield strength, drive torque, and axial pullout strength.
- Torsional Yield Strength: Testing per ASTM F543-23 A1 was conducted. The worst-case subject screws, Ø2.5mm PT screws (MSCP2526), exhibited an average torsional yield strength of 0.66 Nm for six samples. This exceeds the FDA's Bone Screw SPBP Guidance target of 0.6 N-m for a 2.5mm nominal major diameter screw.
- Drive Torque: The subject screws' driving and removal torque was 6.36% of the torsional yield strength, which is within the FDA's Bone Screw SPBP Guidance acceptance criteria of less than 50%. Testing was performed in accordance with ASTM F543-23 Annex A2.
- Axial Pullout Strength: An engineering analysis was performed. The results demonstrated substantially equivalent performance compared to the predicate device and met the FDA's Bone Screw Guidance acceptance criteria for predicted shear failure force.
No animal or clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Torsional Yield Strength: Ø2.5mm PT screws (MSCP2526) exhibited an average torsional yield strength of 0.66 Nm.
- Drive Torque: 6.36% of the torsional yield strength.
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.
Medline Cannulated Screw K130319
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
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.
August 2, 2024
Medline Industries, LP Jennifer Mason Regulatory Affairs Principal Three Lakes Drive Northfield, Illinois 60030
Re: K241359
Trade/Device Name: Medline UNITE® MIS Foot Recon Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 13, 2024 Received: May 14, 2024
Dear Jennifer Mason:
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.
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"
1
K241359 - Jennifer Mason
(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.
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 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 -S
Shumaya Ali, M.P.H. 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
2
Indications for Use
Submission Number (if known)
Device Name
Medline UNITE® MIS Foot Recon Screw System
Indications for Use (Describe)
The Medline UNITE® MIS Foot Recon Screw System is indicated for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions (arthrodeses), and fractures of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle. Screws are intended for single use only.
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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ledline Industries, LP Three Lakes Drive Northfield. IL 60093
K241359 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Contact Person: Jennifer Mason, Regulatory Affairs Principal Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date July 18, 2024
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline UNITE® MIS Foot Recon Screw System Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Product Code: HWC Classification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3040
Predicate Device
Medline Cannulated Screw K130319
Device Description
The Medline UNITE® MIS Foot Recon Screw System includes screws manufactured from Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 or IOS 5832-3. The screws are offered in various diameters from 2.5mm up to 4.0mm and overall lengths ranging from 14mm up to 70mm. The screws are single use and provided
4
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edline Industries. L Three Lakes Drive Northfield II 60093
non-sterile intended to be cleaned and steam sterilized prior to use. The system also includes non-sterile, single use instrumentation necessary to implant the screws, e.g. drill bits and countersinks. Validated cleaning and sterilization instructions are included in the instructions for use.
Indications for Use
The Medline UNITE® MIS Foot Recon Screw System is indicated for the stabilization and fixation of bone reconstructions, osteotomies, joint fusions (arthrodeses), and fractures of short (tarsals) and long (metatarsals, phalanges, distal tibia and fibula) bones comprising the foot and ankle. Screws are intended for single use only.
Summary of Technological Characteristics
The proposed Medline UNITE® MIS Foot Recon Screw System and the predicate device have the same intended use.
The design features of the Medline UNITE® MIS Foot Recon Screw System are compared to the predicate, Medline Cannulated Screws (K130319) in the table below.
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline UNITE® MIS Foot
Recon Screw System | Medline Cannulated Screw | Different |
| 510(k) Reference | N/A | K130319 | Different |
| Product Owner | Medline Industries, LP | Medline Industries, LP | Same |
| Product Code | HWC | HWC | Same |
| Intended Use | The Medline UNITE® MIS
Foot Recon Screw System is
indicated for the stabilization
and fixation of bone
reconstructions, osteotomies,
joint fusions (arthrodeses),
and fractures of short
(tarsals) and long
(metatarsals, phalanges,
distal tibia and fibula) bones
comprising the foot and
ankle. Screws are intended
for single use only. | The Medline Cannulated
Screws are indicated for use in
bone reconstruction,
osteotomies, arthrodesis, joint
fusion, fracture repair, and
fracture fixation of bones
appropriate for the size of the
device. Screws are intended for
single use only. | Same |
| Regulation Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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Medline Industries, LP Three Lakes Drive Northfield. IL 60093
| Screw Diameters | 2.5mm, 3.0mm, 3.5mm,
4.0mm | 2.0mm, 2.5mm, 3.0mm, 3.5mm,
4.0mm, 6.5mm, 7.5mm | Similar |
|-----------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------|
| Screw Lengths | 2.5mm: 14-40mm
3.0mm: 14-50mm
3.5mm: 16-70mm
4.0mm: 20-70mm | 2.0mm: 10-24mm
2.5mm: 10-40mm
3.0mm: 10-40mm
3.5mm: 12-50mm
4.0mm: 14-50mm
6.5mm: 40-130mm
7.5mm: 40-130mm | Similar |
| Materials | Titanium Alloy | Titanium Alloy | Same |
| Design Features | Torx drive mechanism,
self-tapping and self-drilling | Torx drive mechanism,
self-tapping and self-drilling | Same |
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs. Non-
Disposable | Non-Disposable - Screw
Implants
Disposable - Drills and
countersinks | Non-Disposable - Screw
Implants | Similar |
| Single Use vs. Reusable | Single use | Single use | Same |
Summary of Non-Clinical Testing
The subject Medline UNITE® MIS Foot Recon Screw System does not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws.
- Torsional Yield Strength O
- I The worst-case analysis predicted the subject screws, Medline UNITE® MIS Foot Recon Screw System (K241359), did not create a new worst-case compared to the predicate (K130319) with regard to torsional yield strength. However, testing per ASTM F543-23 was conducted to confirm the analysis. This is highlighted in the provided test reports (TR3270-001 Medline ASTM F543 Torsional Properties and Driving Torque Testing for 2.0mm Headed Screws Final Report.pdf, TR3270-002 Medline ASTM F543 Torsional Properties and Driving Torque Testing for 2.5mm PT Screws Final Report.pdf). The worst-case subject screws, Ø2.5mm PT screws (MSCP2526), were evaluated for torsional yield strength in accordance with ASTM F543-23 A1, exhibiting an average torsional vield strength of 0.66 Nm for six samples compared to the predicate screws, Ø2.0mm Headed Screws (MSD02016), which exhibited an average torsional vield strength of 0.50 N-m . The results from the Ø2.5mm PT Screws exceeds the FDA's Bone Screw SPBP Guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-
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Medline Industries, LP Three Lakes Drive Northfield. IL 60093
non-spinal-metallic-bone-screws-and-washers-performance-criteria-safety-and-performance ), which is 0.6 N-m for a 2.5mm nominal major diameter screw
o Drive Torque
- I The subject screws, the driving and removal torque was only 6.36% of the torsional yield strength. which falls within the the FDA's Bone Screw SPBP Guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedicnon-spinal-metallic-bone-screws-and-washers-performance-criteria-safety-and-performance ) acceptance criteria of driving or removal torque being less than 50% of the torsional vield.
- 트 The worst-case subject screws were evaluated for drive torque (insertion, removal) in accordance with ASTM F543-23 Annex A2 and met the FDA'S Bone Screw Guidance acceptance criteria for driving torque being less than 50% of the torsional yield strength of the subject screw.
- 0 Axial Pullout Strength
- 트 An engineering analysis was performed to evaluate the axial pullout strength of the worstcase subject screws. The results demonstrated substantially equivalent performance compared to the predicate, Medline Cannulated Screws (K130319) and met the FDA'S Bone Screw Guidance acceptance criteria for predicted shear failure force.
Performance Testing (Animal)
This section does not apply. No animal testing was performed.
Performance Testing (Clinical)
This section does not apply. No clinical testing was performed.
Summary of Clinical Testing
Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, LP concludes that the Medline UNITE® MIS Foot Recon Screw System is as safe and as effective for their intended use as the predicate device, Medline Cannulated Screws (K130319).