(196 days)
Not Found
No
The device description and intended use are purely mechanical/material-based, and there is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes.
The device is indicated for soft tissue reattachment procedures due to injury or degenerative disease, which are therapeutic interventions.
No
The device, Legends Orthopedics Suture Anchors, is an internal fixation device intended for soft tissue reattachment procedures. Its function is to fix tissue, not to diagnose a condition.
No
The device description clearly states the device is a physical implantable suture anchor made of PEEK plastic, supplied with or without physical sutures and inserters. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Legends Orthopedics Suture Anchors are described as internal fixation devices used for soft tissue reattachment during surgical procedures. They are implanted directly into the body to help repair ligaments, tendons, and capsules.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Legends Orthopedics Suture Anchors fall under the category of surgical implants or orthopedic devices, not In Vitro Diagnostics.
N/A
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
The anchors are composed of polyetheretherketone (PEEK). The high strength suture is made from non-absorbable Ultra High Molecular Weight Polyvethylene (UHMWPE). The implants are ethylene oxide (ETO) sterilized. All implants are supplied in sterile condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, elbow, wrist/hand, foot/ankle, and knee.
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)
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.
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
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.
1
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
2
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.
3
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4
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
5
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.
6
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.
7
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 Suture
Anchors (Legends Orthopedics
5.5 mm Suture Anchors,
Legends Orthopedics 2.9 mm
Suture Anchor, and Legends | RoG Sports Medicine
Suture Anchor, K111590
(predicate device) | Comments |
|-----------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | | Orthopedics 5.5 mm Knotless
Suture Anchor) (subject device) | | |
| 1. | Manufacturer | Legends Orthopedics | RoG ™ Sports Medicine | - |
| 2. | Product Code | MBI | MBI | Same |
| 3. | Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
| 4. | Classification | Class II | Class II | Same |
| 5. | Intended
Use/
Indications
for Use | The Legends Orthopedics
5.5 mm 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: 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, hallux
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 | The RoG Sports Medicine
5.5 mm 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: 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, hallux
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 | Same |
| | | ligament/tendon repair iliotibial | collateral ligament repair | |
Table 2: Substantial Equivalence Table
8
9
| 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 |
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
|---|
10
| | | capsulolabral reconstruction,
acromio-clavicular separation,
deltoid repair, biceps tenodesis. | elbow, wrist/hand, foot/ankle
and knee. Specific
indications are as follows: | |
|-----|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | | | | |
| | | | | |
| | | | | |
| | | Wrist/Hand indications: -
Ulnar/Radial collateral ligament
reconstruction, scapholunate
ligament reconstruction. | Shoulder indications: -
Bankart repair, rotator cuff
repair, SLAP lesion repair,
capsule repair or
capsulolabral reconstruction,
acromio-clavicular
separation, deltoid repair,
biceps tenodesis. | |
| | | Foot/Ankle indications: - Achilles
tendon repair/reconstruction,
hallax valgus reconstruction,
lateral stabilization, medial
stabilization, mid- and forefoot
reconstructions. | Wrist/Hand indications: -
Ulnar/Radial collateral
ligament reconstruction,
scapholunate ligament
reconstruction. | |
| | | Elbow indications: - Biceps
tendon reconstruction, ulnar or
radial collateral ligament
reconstruction, lateral
epicondylitis repair. | Foot/Ankle indications: -
Achilles tendon
repair/reconstruction, hallax
valgus reconstruction, lateral
stabilization, medial
stabilization, mid- and
forefoot reconstructions. | |
| | | Knee indications: - Lateral
collateral ligament repair, medial
collateral ligament repair,
posterior oblique ligament
repair, patellar ligament/tendon
repair. iliotibial band tenodesis,
joint capsule closure. | 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. | |
| | | | | |
| | | Design | | |
| 6. | Anchor
Diameters | 2.9mm Anchor
5.5mm Anchor | 2.9mm Anchor
5.5mm Anchor | Same |
| 7. | Anchor
Geometry | 2.9mm Anchor: 10mm length
5.5mm Anchor: 17.5mm length | 2.9mm Anchor: 10mm length
5.5mm Anchor: 17.5mm length | Same |
| 8. | Anchor Material | polyetheretherketone (PEEK) | polyetheretherketone (PEEK) | Same |
| 9. | Suture Material | USP #2 Ultra High Molecular
Weight Polyethylene (UHMWPE) | USP #2 Ultra High Molecular
Weight Polyethylene
(UHMWPE) | Same |
| 10. | Suture Configuration | Braided multifilament (supplied by
Riverpoint Medical, K100006) | Braided multifilament (supplied
by Riverpoint Medical,
K100006) | Same |
| 11. | Range of
Suture
Diameter | .50-.599 (USP #2) | .50-.599 (USP #2) | Same |
| 12. | Method of
Fixation of
Suture to
Anchor | Knotted Design:
Distal eyelet of anchor
Knotless Design:
through body of anchor | Knotted Design:
Distal eyelet of anchor
Knotless Design:
through body of anchor | Same |
| 13. | Sterilization | Provided in Sterile conditions (EO
Sterilization). | Provided in Sterile conditions
(EO Sterilization). | Same |
| 14. | Single
Use/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 for | |
| Polyetheretherketone (PEEK) Polymers for | |
| Surgical Implant Applications | Same |
| SP-NF M80200_04_01 | |
| Non-absorbable Surgical Suture | Same |
| USP-NF M99670_02_01 | |
| Tensile Strength | Same |
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| USP-NF M99650_02_01 | Same |
|---|---|
| Sutures - Diameter | Same |
| ISO 11135-1:2007 Sterilization of Healthcare | |
| Products - Part 1: Requirements for | |
| development, validation, and routine control of a | |
| sterilization process for medical devices. | Same |
| ISO 10993-7:2008 "Biological evaluation of | |
| medical devices--Part 7: Ethylene oxide | |
| sterilization residuals" | Same |
| ISO 11607-1:2006 – “Packaging for terminally | |
| sterilized medical devices--Part 1: | |
| Requirements for materials, sterile barrier | |
| systems and packaging systems. | Same |
| ISO14971:2007 “Medical Devices – application | |
| of risk management to medical devices" | Same |
| ASTM F543 (Standard Specification and Test | |
| Methods for Metallic Bone Screws) as a | |
| guideline Guidance Document for Testing | |
| Bone Anchor Devices | Same |
| The mechanical and physical properties were | |
| compared to the minimum requirements | |
| specified in ASTM F 2026 for surgically | |
| implantable 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.