(196 days)
The Legends Orthopedics 5.5 mm Suture Anchors is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee.
Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee: a Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures.
Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Scapholunate ligament reconstruction.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee.
Specific indications are as follows:
Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand indications: - Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) are an internal fixation device intended to aid in arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation. due to injury or degenerative disease.
The subject device(s) is screw-like in shape and composed exclusively of PEEK plastic. The 5.5mm (17.5mm length) is available in both standard "knotted" and "knotless" configurations. The implantable anchor devices are available in diameters of 5.5mm (17.5mm length) and 2.9mm diameter (10mm length) and provided in sterile condition.
They 5.5mm & 2.9 Suture Anchors are provided sterile and supplied with nonabsorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.
The 5.5 knotless Suture Anchors are provided sterile no suture. Components are available in a range of sizes to meet the needs of an individual patient.
The 5.5mm suture anchor is supplied in two designs:
with USP #2 high strength non-absorbable polyethylene suture(s) intended to be knotted and Knotless without any suture and suture attachment does not require knot tying.
The 2.9mm suture anchor is supplied in two designs:
- i. with USP #2 high strength non-absorbable polyethylene suture(s) and where the anchor must be attached to the inserter before use and
- ii. where the anchors are provided preloaded on single use inserters.
The anchors are composed of polyetheretherketone (PEEK). The high strength suture is made from non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE). The implants are ethylene oxide (ETO) sterilized. All implants are supplied in sterile condition.
This document is a 510(k) Premarket Notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the way you might expect for a digital health or AI device. Instead, it relies on demonstrating that the new device is functionally and materially similar to an already approved device.
Here's an breakdown based on the provided text, addressing your points where applicable, and noting where information is not present for this type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" and "reported device performance" in the typical format of a study for an AI or digital health device with specific metrics like sensitivity, specificity, etc. Instead, it justifies substantial equivalence by comparing technological characteristics and adherence to recognized standards.
Here's a table summarizing the comparison to the predicate device, which serves as the basis for performance acceptance in a 510(k) of this type:
| Parameter | Acceptance Criteria (based on Predicate Device K111590) | Reported Device Performance (Legends Orthopedics Suture Anchors) | Comments |
|---|---|---|---|
| Intended Use | Indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee. | Indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee. | Identical |
| Indications for Use | Detailed list of specific indications for 5.5 mm, 2.9 mm, and 5.5 mm Knotless Suture Anchors across shoulder, wrist/hand, foot/ankle, elbow, and knee (e.g., Bankart repair, rotator cuff repair, Achilles tendon repair). | Detailed list of specific indications for 5.5 mm, 2.9 mm, and 5.5 mm Knotless Suture Anchors across shoulder, wrist/hand, foot/ankle, elbow, and knee (e.g., Bankart repair, rotator cuff repair, Achilles tendon repair). Contains minor additional indications for 2.9 mm anchor (extracapsular repair, vastus medialis obliquus (VMO) muscle advancement) which were likely also cleared for the predicate. | Identical |
| Materials | Polyetheretherketone (PEEK) for anchor, Ultra High Molecular Weight Polyethylene (UHMWPE) for suture. | Polyetheretherketone (PEEK) for anchor, Ultra High Molecular Weight Polyethylene (UHMWPE) for suture. | Identical |
| Design Features | Anchor diameters: 2.9mm and 5.5mm. Anchor geometry: 2.9mm (10mm length), 5.5mm (17.5mm length). Suture configuration: Braided multifilament (USP #2, 0.50-0.599mm). Method of fixation: Distal eyelet for knotted, through body for knotless. | Anchor diameters: 2.9mm and 5.5mm. Anchor geometry: 2.9mm (10mm length), 5.5mm (17.5mm length). Suture configuration: Braided multifilament (USP #2, 0.50-0.599mm). Method of fixation: Distal eyelet for knotted, through body for knotless. | Identical |
| Sterilization | Provided in Sterile conditions (EO Sterilization). | Provided in Sterile conditions (EO Sterilization). | Identical |
| Performance Standards | Adherence to recognized standards like ASTM F2026-17 (PEEK polymers), SP-NF M80200_04_01 (Non-absorbable Suture), USP-NF M99670_02_01 (Tensile Strength), USP-NF M99650_02_01 (<861> Sutures - Diameter), ISO 11135-1:2007 (Sterilization), ISO 10993-7:2008 (Ethylene oxide residuals), ISO 11607-1:2006 (Packaging), ISO 14971:2007 (Risk Management), and ASTM F543 (guideline for bone anchor testing). Also, mechanical and physical properties compared to ASTM F2026 for PEEK. | Adherence to the same recognized standards: ASTM F2026-17, SP-NF M80200_04_01, USP-NF M99670_02_01, USP-NF M99650_02_01, ISO 11135-1:2007, ISO 10993-7:2008, ISO 11607-1:2006, ISO14971:2007, ASTM F543 guideline. Mechanical and physical properties compared to ASTM F2026 for PEEK. | Same |
| Single Use/Reuse | Single Use | Single Use | Same |
| Shelf Life | 5 years | 5 years | Same |
The study that "proves the device meets the acceptance criteria" in this context is the non-clinical laboratory testing performed by "RoG Sports Medicine" (presumably to ensure consistency across batches as the predicate device manufacturer). The submission states: "Non-clinical laboratory testing was performed by RoG Sports Medicine to determine substantial equivalence. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the Legends Orthopedics Suture Anchors... and the predicate device. The results indicated that the devices were functional within their intended use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "non-clinical laboratory testing" without specifying sample sizes for these tests, which typically involve mechanical or material characterization rather than patient data. Data provenance like country of origin or retrospective/prospective status is irrelevant for this type of submission focused on material and mechanical equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. For a device like a suture anchor, "ground truth" established by experts in the context of clinical image interpretation or AI output is not relevant. The "ground truth" for these devices revolves around material properties and mechanical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiological reads) to establish a consensus ground truth. For mechanical testing of a suture anchor, such a method is not used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. MRMC studies are used to evaluate AI systems in diagnostic imaging. This device is a physical surgical implant, not an AI or diagnostic imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established material specifications, mechanical testing standards, and performance characteristics of the legally marketed predicate device. In essence, the predicate device's proven safety and effectiveness, supported by its own non-clinical data and adherence to standards, serves as the "ground truth" for comparison.
8. The sample size for the training set
This information is not applicable/not provided. This device is not an AI/ML product that would require a 'training set'.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, no training set is relevant for this type of device.
In summary, this 510(k) submission for the Legends Orthopedics Suture Anchors demonstrates substantial equivalence by showing that the new device has identical intended use, indications for use, materials, design features, sterilization, and overall performance characteristics to a predicate device (RoG™ Sports Medicine Suture Anchor, K111590). The "study" that supports this is a series of non-clinical laboratory tests comparing the subject device to the predicate device and confirming adherence to relevant industry standards. Clinical trials were not conducted or deemed necessary for this type of submission, as the fundamental technology and performance are considered equivalent to an already approved device.
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September 11, 2023
Image /page/0/Picture/1 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.
Jarmon Medical, LLC (DBA Legends Orthopedics) % W. Victoria Rogers Regulatory Affairs Consultant Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783
Re: K230517
Trade/Device Name: Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 24, 2023 Received: July 24, 2023
Dear W. Victoria Rogers:
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.
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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 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.
Sara S. Thompson -S
For
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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Indications for Use
510(k) Number (if known) K230517
Device Name
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
Indications for Use (Describe)
The Legends Orthopedics 5.5 mm Suture Anchors is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee.
Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, Capsule repair or capsulolabral reconstruction, acromoclavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle: Achilles tendon repair/reconstruction, hateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylits repair. Knee: a Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair or capsulolabral reconstruction, acromioclavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Scapholunate ligament reconstruction.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament tendon repair. iliotibial band tenodesis, joint capsular repair, vastus medialis obliquus (VMO) muscle advancement.
The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee.
Specific indications are as follows:
Shoulder indications: - Bankart repair, rotator cuff repair, capsule repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand indications: - Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
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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510(k) Summary [As required by 807.92(a)]
1. 510(k) Summary
1.1. Submitter Information:
Legends Orthopedics 169 E. Reynolds Road, Suite 203B Lexington, Kentucky 40517
-
Jeremy Jarmon Contact Person: Title: President/CEO Telephone: 800-741-3995
Designated Submission Correspondent: -
W. Victoria Rogers Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783 574-265-8356
Date prepared: 11 September 2023
1.2. Device Identification:
Trade Name: Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
Common Name: Suture Anchor
Classification Name: Fastener, fixation non-degradable, soft tissue
Device Classification: Class II
Regulation Number: 21 CFR 888.3040
Product Code : MBI
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1.3. Predicate Device:
| Device Name | 510(k) Number |
|---|---|
| RoG™ Sports Medicine Suture Anchor | K111590 |
1.4. Device Description
The Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) are an internal fixation device intended to aid in arthroscopic and orthopedic reconstructive procedures needing soft tissue fixation. due to injury or degenerative disease.
The subject device(s) is screw-like in shape and composed exclusively of PEEK plastic. The 5.5mm (17.5mm length) is available in both standard "knotted" and "knotless" configurations. The implantable anchor devices are available in diameters of 5.5mm (17.5mm length) and 2.9mm diameter (10mm length) and provided in sterile condition.
They 5.5mm & 2.9 Suture Anchors are provided sterile and supplied with nonabsorbable polyethylene suture. The anchor is supplied with reusable taps and guides of corresponding size.
The 5.5 knotless Suture Anchors are provided sterile no suture. Components are available in a range of sizes to meet the needs of an individual patient.
The 5.5mm suture anchor is supplied in two designs:
with USP #2 high strength non-absorbable polyethylene suture(s) intended to be knotted and Knotless without any suture and suture attachment does not require knot tying.
The 2.9mm suture anchor is supplied in two designs:
- i. with USP #2 high strength non-absorbable polyethylene suture(s) and where the anchor must be attached to the inserter before use and
- ii. where the anchors are provided preloaded on single use inserters.
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The anchors are composed of polyetheretherketone (PEEK). The high strength suture is made from non-absorbable Ultra High Molecular Weight Polvethylene (UHMWPE). The implants are ethylene oxide (ETO) sterilized. All implants are supplied in sterile condition.
1.5 Intended Use & Indications for Use
The Legends Orthopedics 5.5 mm Suture Anchors is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle, and knee.
Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle: Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee: a Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures.
Specific indications are as follows:
Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand: Scapholunate ligament reconstruction.
Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.
The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee.
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Specific indications are as follows:
Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.
Wrist/Hand indications: - Ulnar/Radial collateral ligament reconstruction, scapholunate ligament reconstruction.
Foot/Ankle indications: - Achilles tendon repair/reconstruction, hallax valgus reconstruction, lateral stabilization, medial stabilization, mid- and forefoot reconstructions.
Elbow indications: - Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction, lateral epicondylitis repair.
Knee indications: - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.
1.6 Summary of Technological Characteristics:
The fundamental scientific technology, materials of construction and mechanism of operation is identical between the subject device Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) and the predicate device.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicate ●
- Indications for Use: Identical to predicate
- Materials: Identical to predicate ●
- Design Features: Identical to predicate ●
- Sterilization: Identical to predicate .
Table 2 summarizes the comparison of technological characteristics between the subject and predicate device
| S.No. | Parameters | Legends Orthopedics SutureAnchors (Legends Orthopedics5.5 mm Suture Anchors,Legends Orthopedics 2.9 mmSuture Anchor, and Legends | RoG Sports MedicineSuture Anchor, K111590(predicate device) | Comments |
|---|---|---|---|---|
| Orthopedics 5.5 mm KnotlessSuture Anchor) (subject device) | ||||
| 1. | Manufacturer | Legends Orthopedics | RoG ™ Sports Medicine | - |
| 2. | Product Code | MBI | MBI | Same |
| 3. | RegulationNumber | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
| 4. | Classification | Class II | Class II | Same |
| 5. | IntendedUse/Indicationsfor Use | The Legends Orthopedics5.5 mm Suture Anchor isindicated for soft tissuereattachment procedures in theshoulder, elbow, wrist/hand,foot/ankle and knee. Specificindications are as follows:Shoulder: Bankart repair, rotatorcuff repair, SLAP lesion repair,capsule repair or capsulolabralreconstruction, acromio-clavicular separation, deltoidrepair, biceps tenodesis.Wrist/Hand: Ulnar/Radialcollateral ligamentreconstruction, scapholunateligament reconstruction.Foot/Ankle: Achilles tendonrepair/reconstruction, halluxvalgus reconstruction, lateralstabilization, medialstabilization, mid- and forefootreconstructions.Elbow: Biceps tendonreconstruction, ulnar or radialcollateral ligamentreconstruction, lateralepicondylitis repair.Knee: a Lateral collateralligament repair, medial collateralligament repair, posterioroblique ligament repair, patellar | The RoG Sports Medicine5.5 mm Suture Anchor isindicated for soft tissuereattachment procedures inthe shoulder, elbow,wrist/hand, foot/ankle andknee. Specific indications areas follows:Shoulder: Bankart repair,rotator cuff repair, SLAPlesion repair, capsule repairor capsulolabralreconstruction, acromio-clavicular separation, deltoidrepair, biceps tenodesis.Wrist/Hand: Ulnar/Radialcollateral ligamentreconstruction, scapholunateligament reconstruction.Foot/Ankle: Achilles tendonrepair/reconstruction, halluxvalgus reconstruction,lateral stabilization, medialstabilization, mid- andforefoot reconstructions.Elbow: Biceps tendonreconstruction, ulnar or radialcollateral ligamentreconstruction, lateralepicondylitis repair.Knee: a Lateral collateralligament repair, medial | Same |
| ligament/tendon repair iliotibial | collateral ligament repair |
Table 2: Substantial Equivalence Table
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| band tenodesis, joint capsule closure.The Legends Orthopedics 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.Wrist/Hand: Scapholunate ligament reconstruction.Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.The Legends Orthopedics 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle and knee. Specific indications are as follows:Shoulder indications: - Bankart repair, rotator cuff repair, SLAP lesion repair capsule repair or | posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure.The RoG Sports Medicine 2.9 mm Suture Anchor is indicated for use in soft tissue reattachment procedures. Specific indications are as follows:Shoulder: Bankart repair, rotator cuff repair, SLAP lesion repair, capsule repair or capsulolabral reconstruction, acromio-clavicular separation, deltoid repair, biceps tenodesis.Wrist/Hand: Scapholunate ligament reconstruction.Elbow: Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.Knee: Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar ligament/tendon repair. iliotibial band tenodesis, joint capsule closure, extracapsular repair, vastus medialis obliquus (VMO) muscle advancement.The RoG Sports Medicine 5.5 mm Knotless Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder | Same |
|---|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
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| capsulolabral reconstruction,acromio-clavicular separation,deltoid repair, biceps tenodesis. | elbow, wrist/hand, foot/ankleand knee. Specificindications are as follows: | |||
|---|---|---|---|---|
| Wrist/Hand indications: -Ulnar/Radial collateral ligamentreconstruction, scapholunateligament reconstruction. | Shoulder indications: -Bankart repair, rotator cuffrepair, SLAP lesion repair,capsule repair orcapsulolabral reconstruction,acromio-clavicularseparation, deltoid repair,biceps tenodesis. | |||
| Foot/Ankle indications: - Achillestendon repair/reconstruction,hallax valgus reconstruction,lateral stabilization, medialstabilization, mid- and forefootreconstructions. | Wrist/Hand indications: -Ulnar/Radial collateralligament reconstruction,scapholunate ligamentreconstruction. | |||
| Elbow indications: - Bicepstendon reconstruction, ulnar orradial collateral ligamentreconstruction, lateralepicondylitis repair. | Foot/Ankle indications: -Achilles tendonrepair/reconstruction, hallaxvalgus reconstruction, lateralstabilization, medialstabilization, mid- andforefoot reconstructions. | |||
| Knee indications: - Lateralcollateral ligament repair, medialcollateral ligament repair,posterior oblique ligamentrepair, patellar ligament/tendonrepair. iliotibial band tenodesis,joint capsule closure. | Elbow indications: - Bicepstendon reconstruction, ulnaror radial collateral ligamentreconstruction, lateralepicondylitis repair. | |||
| Knee indications: - Lateralcollateral ligament repair,medial collateral ligamentrepair, posterior obliqueligament repair, patellarligament/tendon repair.iliotibial band tenodesis, jointcapsule closure. | ||||
| Design | ||||
| 6. | AnchorDiameters | 2.9mm Anchor5.5mm Anchor | 2.9mm Anchor5.5mm Anchor | Same |
| 7. | AnchorGeometry | 2.9mm Anchor: 10mm length5.5mm Anchor: 17.5mm length | 2.9mm Anchor: 10mm length5.5mm Anchor: 17.5mm length | Same |
| 8. | Anchor Material | polyetheretherketone (PEEK) | polyetheretherketone (PEEK) | Same |
| 9. | Suture Material | USP #2 Ultra High MolecularWeight Polyethylene (UHMWPE) | USP #2 Ultra High MolecularWeight Polyethylene(UHMWPE) | Same |
| 10. | Suture Configuration | Braided multifilament (supplied byRiverpoint Medical, K100006) | Braided multifilament (suppliedby Riverpoint Medical,K100006) | Same |
| 11. | Range ofSutureDiameter | .50-.599 (USP #2) | .50-.599 (USP #2) | Same |
| 12. | Method ofFixation ofSuture toAnchor | Knotted Design:Distal eyelet of anchorKnotless Design:through body of anchor | Knotted Design:Distal eyelet of anchorKnotless Design:through body of anchor | Same |
| 13. | Sterilization | Provided in Sterile conditions (EOSterilization). | Provided in Sterile conditions(EO Sterilization). | Same |
| 14. | SingleUse/Reuse | Single Use | Single Use | Same |
| 15. | Shelf Life | 5 years | 5 years | Same |
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Summary of Performance Data 1.7
Non-Clinical Tests:
Non-clinical laboratory testing was performed by RoG Sports Medicine to determine substantial equivalence. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) and the predicate device.
The results indicated that the devices were functional within their intended use.
| Predicate device K111590 | Proposed device |
|---|---|
| ASTM F2026-17 Standard Specification forPolyetheretherketone (PEEK) Polymers forSurgical Implant Applications | Same |
| SP-NF M80200_04_01Non-absorbable Surgical Suture | Same |
| USP-NF M99670_02_01<881> Tensile Strength | Same |
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| USP-NF M99650_02_01 | Same |
|---|---|
| <861> Sutures - Diameter | Same |
| ISO 11135-1:2007 Sterilization of HealthcareProducts - Part 1: Requirements fordevelopment, validation, and routine control of asterilization process for medical devices. | Same |
| ISO 10993-7:2008 "Biological evaluation ofmedical devices--Part 7: Ethylene oxidesterilization residuals" | Same |
| ISO 11607-1:2006 – “Packaging for terminallysterilized medical devices--Part 1:Requirements for materials, sterile barriersystems and packaging systems. | Same |
| ISO14971:2007 “Medical Devices – applicationof risk management to medical devices" | Same |
| ASTM F543 (Standard Specification and TestMethods for Metallic Bone Screws) as aguideline Guidance Document for TestingBone Anchor Devices | Same |
| The mechanical and physical properties werecompared to the minimum requirementsspecified in ASTM F 2026 for surgicallyimplantable grade of PEEK | Same |
1.8 Clinical Tests:
None provided as a basis for substantial equivalence.
1.9 Substantial Equivalence Conclusion:
The Legends Orthopedic Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) under this premarket notification submission are the same in design, intended use, technological characteristics, sterilization and are composed of the same materials as its predicate. This product has the same performance characteristics and conforms to the same standards. There are no differences between the subject device and the predicate devices regarding safety and effectiveness that would affect the use of the product. As such, the Legends Orthopedic Suture Anchors are the same as its primary predicate.
From the data available we can justify that the Legends Orthopedic Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) are safe, and as effective and performs the same indications for use as that of already marketed predicate device identified in 1.3 of 510(k) summary.
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There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product.
§ 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.