(28 days)
Not Found
No
The summary describes a physical implant device and its materials, dimensions, and intended use for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical properties and biocompatibility, not algorithmic performance.
No.
The device is an implantable medical device used for bone reconstruction and fracture repair, which are surgical interventions, not therapeutic treatments.
No
The device is a medical implant used for bone reconstruction, fracture repair, and fixation; it does not collect or analyze any data to diagnose a condition.
No
The device description clearly states that the device is a physical implant made of Titanium Alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Medline UNITE® IM Fibula Implants are used for bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are all procedures performed on the body, not with specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
This device is a surgical implant used directly in the body for structural support and repair.
N/A
Intended Use / Indications for Use
Medline UNITE® IM Fibula Implants are in bone reconstruction, osteotomes, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Implants are intended for single use only.
Product codes
HWC
Device Description
The Medline UNITE® IM Fibula Implants 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. The Medline UNITE® IM Fibula Implants are manufactured from Titanium Alloy per ASTM F136 and ISO 5832-3. The implants are offered in a 3.7/4.0mm tapered diameter with fully threaded lengths ranging from 65mm to 150mm. The implants are single use only and provided non-sterile.
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 Medline UNITE® IM Fibula Implants do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). Analysis was conducted to further demonstrate substantial equivalence of the Medline UNITE® IM Fibula Implants to the predicate. Medline Cannulated Screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
March 22, 2022
U.S. FOOD & DRUG
ADMINISTRATION
Medline Industries, LP Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093
Re: K220511
Trade/Device Name: Medline UNITE® IM Fibula Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 15, 2022 Received: February 22, 2022
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 (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
1
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 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, M.P.H. 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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Indications for Use
510(k) Number (if known) K220511
Device Name Medline UNITE® IM Fibula Implant
Indications for Use (Describe)
Medline UNITE® IM Fibula Implants are in bone reconstruction, osteotomes, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Implants 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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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
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, Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date March 21, 2022
Type of 510(k) Submission Special
Device Name / Classification
Trade Name: Medline UNITE® IM Fibula Implant Common Name: Screw, Fixation Bone Classification Name: Smooth or threaded bone fixation fastener Product Code: HWC Classification Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3040
Predicate Device
Medline Cannulated Screw: K130319
Device Description
The Medline UNITE® IM Fibula Implants 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. The Medline UNITE® IM Fibula Implants are manufactured from Titanium Alloy per ASTM F136 and ISO 5832-3. The implants are offered in a 3.7/4.0mm tapered diameter with fully threaded lengths ranging from 65mm to 150mm. The implants are single use only and provided non-sterile.
4
Medline Industries, LP Three Lakes Drive Northfield, IL 60093
A comparison of the subject and predicate device is included below in Table 1 and additional detailed subject information can be found in Appendix A in the engineering drawings. The Medline UNITE® IM Fibula Implants are within the currently marketed sizes, diameter and length of the identified predicate device.
Indications for Use
Medline UNITE® IM Fibula Implants 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. Implants are intended for single use only.
Summary of Technological Characteristics
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline UNITE® IM Fibula
Implants | Medline Cannulated Screws | Different |
| Product Photos | Image: Green screw | Image: Purple and blue screw | N/A |
| 510(k) Reference | N/A | K130319 | Different |
| Product Owner | Medline Industries, LP
(previously Medline Industries,
Inc.) | Medline Industries, Inc. | Same |
| Product Code | HWC | HWC | Same |
| Intended Use | Medline UNITE® IM Fibula
Implants 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. Implants are intended
for single use only. | 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 |
| Materials | Titanium Alloy | Titanium Alloy | Same |
| Sizes | 3.7/4.0 x 65mm
3.7/4.0 x 70mm
3.7/4.0 x 75mm
3.7/4.0 x 80mm
3.7/4.0 x 85mm
3.7/4.0 x 90mm | Ø2.0 x 10-24mm
Ø2.5 x 10-40mm
Ø3.0 x 10-40mm
Ø3.5 x 12-50mm
Ø4.0 x 14-50mm
Ø4.5 x 14-70mm | Different |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
| | 3.7/4.0 x 95mm
3.7/4.0 x 100mm
3.7/4.0 x 110mm
3.7/4.0 x 120mm
3.7/4.0 x 130mm
3.7/4.0 x 140mm
3.7/4.0 x 150mm | Ø6.5 x 40-130mm
Ø7.5 x 40-130mm | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------|
| Design Feature | Torx drive mechanism
Self-drilling and self-tapping | Torx drive mechanism
Self-drilling and self-tapping | Same |
| Prescription vs. OTC | Prescription | Prescription | Same |
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single Use vs. Reusable | Single Use | Single Use | Same |
Summary of Non-Clinical Testing
The subject Medline UNITE® IM Fibula Implants do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). Analysis was conducted to further demonstrate substantial equivalence of the Medline UNITE® IM Fibula Implants to the predicate. Medline Cannulated Screws. A summary is present below with more information provided in the applicable sections.
Biocompatibility Testing
The Medline UNITE® IM Fibula Implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The subject device and the predicate device are both manufactured from the identical raw material using the same manufacturing process, therefore, biocompatibility testing was leveraged from the predicate submission to support biocompatibility on the subject device.
Performance Testing (Bench)
The subject device, Medline UNITE® IM Fibula Implants, do not represent a new worst-case when compared to the previously cleared Medline Cannulated Screws (K130319). An engineering analysis was performed to determine that the subject screws do not present a new worst-case for pullout force and torsional yield strength when compared to the predicate. Based on this analysis, the subject device, Medline UNITE® IM Fibula Implants, are substantially equivalent to the predicate, Medline Cannulated Screws.
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
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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
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® IM Fibula Implants are substantially equivalent to the predicate device, Medline Cannulated Screws (K130319).