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)

Q: Who is the manufacturer of 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)?

Jarmon Medical, LLC (Dba Legends Orthopedics) filed the 510(k) submission for 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) (K230517).

Q: What is the FDA product code for 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)?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

Q: What is the regulatory pathway for 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)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for 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)?

RoG™ Sports Medicine Suture Anchor (K111590).

Q: Who can help prepare an FDA 510(k) submission like 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)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K230517 · Jarmon Medical, LLC (Dba Legends Orthopedics) · MBI · Sep 11, 2023 · Orthopedic

Device Facts

Record ID	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)
Applicant	Jarmon Medical, LLC (Dba Legends Orthopedics)
Product Code	MBI · Orthopedic
Decision Date	Sep 11, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended 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. 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.

Device Story

Screw-like internal fixation device; used in arthroscopic/orthopedic reconstructive procedures for soft tissue reattachment. Composed of PEEK plastic; available in 5.5mm (knotted/knotless) and 2.9mm (knotted) diameters. Supplied sterile with non-absorbable UHMWPE suture (knotted versions) or without suture (knotless). Used by surgeons in clinical settings. Implanted into bone to secure soft tissue; provides mechanical fixation to aid healing. Benefits include restoration of anatomical integrity in joints following injury or degenerative disease.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical bench testing, including mechanical property comparisons and adherence to ASTM/ISO standards.

Technological Characteristics

Materials: PEEK (ASTM F2026-17), UHMWPE suture. Form factor: Screw-like anchors (2.9mm, 5.5mm). Sterilization: Ethylene Oxide (ISO 11135-1). Fixation: Mechanical screw-in. Single-use. No software/electronics.

Indications for Use

Indicated for soft tissue reattachment in shoulder, elbow, wrist/hand, foot/ankle, and knee. Procedures include ligament/tendon repairs (e.g., rotator cuff, Achilles, biceps, collateral ligaments) and reconstructions (e.g., Bankart, capsulolabral, hallux valgus).

Regulatory Classification

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.

Predicate Devices

RoG™ Sports Medicine Suture Anchor (K111590)

Related Devices

K113299 — ROG SUTURE ANCHOR · Rog Sports Medicine, Inc. · Dec 15, 2011
K110545 — SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) · Smith & Nephew, Inc. · Jun 24, 2011
K110229 — ROG SUTURE ANCHOR 5.5MM, 2.9MM · Rog Sports Medicine, Inc. · May 18, 2011
K111590 — ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR · Rog Sports Medicine, Inc. · Aug 8, 2011
K110230 — ROG KNOTLESS SUTURE ANCHOR · Rog Sports Medicine, Inc. · May 19, 2011

Submission Summary (Full Text)

{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}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 | {11}------------------------------------------------ #### 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 <881> Tensile Strength | Same | {12}------------------------------------------------ | USP-NF M99650_02_01 | Same | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | <861> 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. {13}------------------------------------------------ There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product.