VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)

Q: Who is the manufacturer of VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)?

Ortho-Design (Pty), Ltd. filed the 510(k) submission for VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK) (K242296).

Q: What is the FDA product code for VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)?

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 VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)?

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

Q: What are the predicate devices for VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)?

VersaTap™ Suture Anchor (K212381); MiniTi™ Suture Anchor (K212381); VersaLat™ Suture Anchor (K212381); DePuy Mitek Healix Advance Knotless BR Anchor (K130917).

Q: Who can help prepare an FDA 510(k) submission like VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)?

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.

K242296 · Ortho-Design (Pty), Ltd. · MBI · Aug 29, 2024 · Orthopedic

Device Facts

Record ID	K242296
Device Name	VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)
Applicant	Ortho-Design (Pty), Ltd.
Product Code	MBI · Orthopedic
Decision Date	Aug 29, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction. The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction. The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: Elbow: Ulnar/Medial Collateral Ligament Repair Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers. The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as: Shoulder: Rotator Cuff Repair, Biceps Tenodesis Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis. Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers.

Device Story

Suture anchors for soft tissue-to-bone fixation in orthopedic surgery; used in arthroscopic or open procedures. Devices include self-tapping screw-in anchors (VersaTap, MicroTi) and knotless suture anchors (VersaLat). Materials include PEEK and Titanium; designs vary by diameter and length to accommodate specific joint sizes. Operated by orthopedic surgeons. Anchors provide mechanical fixation of soft tissue/ligaments to bone; facilitate tendon/ligament repair. Benefits include secure fixation, reduced post-operative imaging artifacts (PEEK models), and flexibility in suture/tape management (knotless models).

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included insertion torque, static pullout, and justification for dynamic pullout (fatigue), component interconnection, and corrosion testing per FDA guidance.

Technological Characteristics

Materials: PEEK and Titanium. Design: Threaded bone fixation fasteners; self-tapping or knotless configurations. Dimensions: Varying diameters and lengths. Sterilization: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring soft tissue-to-bone fixation during general orthopedic surgery, including arthroscopic or open procedures for tendon and ligament repairs in the shoulder, elbow, knee, wrist, and foot/ankle.

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

VersaTap™ Suture Anchor (K212381)
MiniTi™ Suture Anchor (K212381)
VersaLat™ Suture Anchor (K212381)
DePuy Mitek Healix Advance Knotless BR Anchor (K130917)

Reference Devices

KINSA RC Suture Anchor (K070908)
Depuy Mitek QuickAnchor (K071257)
Arthrex Swivelock Anchors (K151342)

Related Devices

K212381 — VersaTap, VersaLat, DueLock, VersaTi, MiniTi · Ortho-Design (Pty), Ltd. · Dec 6, 2021
K180594 — Knotless SutureTak Anchors · Arthrex, Inc. · Jun 22, 2018
K190446 — Responsive Arthroscopy Wedge Push-In Suture Anchors · Responsive Arthroscopy, LLC · Mar 27, 2019
K171020 — Arthrex Knotless SutureTak Anchor · Arthrex, Inc. · May 16, 2017
K231330 — FiberTak® Suture Anchor · Arthrex, Inc. · Jun 1, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. August 29, 2024 Ortho-Design (Pty) Ltd Dian Peach Managing Director 17 Dely Road Hazelwood, Pretoria 0081 South Africa Re: K242296 VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); Trade/Device Name: MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLatTM Suture Anchor (ADP021-PK) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 3, 2024 Dear Dian Peach: Received: August 2, 2024 We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-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/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Christopher Ferreira -S Christopher Ferreira, MS Assistant Director, Biomedical Engineer 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 {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K242296 Device Name VersaTap TM Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture Anchor (ATP003-M); VersaLat™ Ti Suture Anchor (ADP021-TI); VersaLat™ Suture Anchor (ADP021-PK) Indications for Use (Describe) #### VersaTap™ Suture Anchor The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: - · Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair - · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus - · Elbow: Tennis elbow repair - · Knee: Medial and lateral collateral ligament repair. - · Wrist: Scapholunate ligament reconstruction #### VersaPEEK™ Suture Anchor The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: - · Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair - · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus - · Elbow: Tennis elbow repair - · Knee: Medial and lateral collateral ligament repair. - · Wrist: Scapholunate ligament reconstruction #### MicroTi™ Suture Anchor The MicroTi™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The MicroTi™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: - · Elbow: Ulnar/Medial Collateral Ligament Repair · Foot/Ankle: Achilles Tendon Repair, Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-foot Reconstruction, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. · Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction. {3}------------------------------------------------ VersaLat™ Ti Suture Anchor The VersaLat™ Ti Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as: · Shoulder: Rotator Cuff Repair, Biceps Tenodesis · Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. · Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis · Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers. VersaLat™ Suture Anchor The VersaLat™ Suture Anchor is intended to use for fixation of soft tissue and ligaments to bone/ healthy tissue during tendon and ligament repairs, during procedures such as: - · Shoulder: Rotator Cuff Repair, Biceps Tenodesis - · Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. · Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Illiotibial Band Tenodesis. · Foot/Ankle: Lateral stabilization, medial stabilization, Achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, metatarsal tendon repair, bunionectomy, and digital tendon transfers. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) ver-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 The following information is provided in accordance with 21CFR 807.92 for the Premarket 510(k) Summary: | Submitter Information: | Ortho-Design (Pty) Ltd 17 Dely Road Hazelwood, Pretoria, 0081 South Africa | |-----------------------------------------|-------------------------------------------------------------------------------------| | Date: | 26 August 2024 | | Contact Person: Telephone: Email: | Dian Peach, Managing Director (+27) 12 807 1902 dianpeach@ortho-design.co.za | Table 1: Subject devices and their respective submission K212381 predicate devices. | K212381 | The enclosed submission | |-------------------------|---------------------------------------| | VersaTap™ Suture Anchor | VersaTap™ Suture Anchor (Device A) | | | VersaPEEK™ Suture Anchor (Device B) | | MiniTi™ Suture Anchor | MicroTi™ Suture Anchor (Device C) | | VersaLat™ Suture Anchor | VersaLat™ Ti Suture Anchor (Device D) | | | VersaLat™ Suture Anchor (Device E) | Table 2: DEVICE A – VersaTap™ Suture Anchor | | Subject Device | Predicate Device (Cleared in K212381) | |---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Trade Name: | VersaTap™ Suture Anchor | VersaTap™ Suture Anchor (Cleared in K212381) | | Regulation Description: | Smooth or threaded metallic bone fixation fastener. | Smooth or threaded metallic bone fixation fastener. | | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue | Fastener, Fixation, Nondegradable, Soft Tissue | | Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 | | Device Classification: | Class II | Class II | | Product Code: | MBI | MBI | | Reference Device(s): | KINSA RC Suture Anchor (K070908), manufactured by Smith & Nephew | K061665; K173788; K063453, K130274, K070758 | | Device Description: | The VersaTap™ Suture Anchor is a self-tapping suture anchor. This anchor is designed to combine the advantages of both PEEK and Titanium. The titanium tip makes the product self-tapping, whilst the majority of the anchor is manufactured from PEEK to minimize post- operative imaging effects. | The VersaTap™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. This anchor is ingeniously designed to combine the advantage of both PEEK and Titanium. The titanium tip allows for self-tapping ability whilst the majority of the anchor is manufactured from PEEK which minimizes post-operative imaging effects. | | Indications for Use: | The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: • Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus • Elbow: Tennis elbow repair • Knee: Medial and lateral collateral ligament repair. • Wrist: Scapholunate ligament reconstruction. | The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: • Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart repair • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus • Elbow: Tennis elbow repair • Knee: Medial and lateral collateral ligament repair. • Wrist: Scapholunate ligament reconstruction | | Relationship to the Device: | The subject and predicate devices (cleared in K212381) have the same intended use, materials, packaging, and similar design features. | function. | | Technological Differences: | The subject and predicate devices (cleared in K212381) have similar engineering designs with minor dimensional changes. The subject device has a reduced diameter and a reduced length compared to the predicate device (cleared in K212381). | | | Clinical Characteristics: | The subject and predicate devices (cleared in K212381) are intended to be used for soft tissue fixation during general orthopedic surgery. | | | Technical Equivalence: | The subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and performance. | | | Mechanical Testing and Disclosure of Performance and Safety Deviation: | Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381). | | | Biocompatibility: | The subject and predicate devices (cleared in K212381) are manufactured using the same approved suppliers, manufacturing facilities, manufacturing processes, chemicals, materials, and cleaning processes. All manufacturing is conducted according to the processes defined by ISO 13485 and ISO 9001. All materials, processes, and cleaning agents used for the subject device have been used in the previously cleared device(s). Therefore biocompatibility of the subject device is substantially equivalent to the predicate device. The subject devices have been tested to be non-pyrogenic. | | | Quality Control Measures | For both the subject and predicate device (cleared in K212381) the methods, thresholds and criteria of the following are identical: Sterility Self-Life Packaging Pyrogenicity / Endotoxin Testing | | | Conclusion: | The subject device demonstrates substantial equivalence by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests and adheres to the minimum requirements set out in FDA's guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions. | | | | Subject Device | Predicate Device (Cleared in K212381) | | Device Trade Name: | VersaPEEK™ Suture Anchor | VersaTap™ Suture Anchor (Cleared in K212381) | | Regulation Description: | Smooth or threaded metallic bone fixation fastener. | Smooth or threaded metallic bone fixation fastener. | | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue | Fastener, Fixation, Nondegradable, Soft Tissue | | Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 | | Device Classification: | Class II | Class II | | Product Code: | MBI | MBI | | Reference Device(s): | KINSA RC Suture Anchor (K070908), manufactured by Smith & Nephew | K061665; K173788; K063453, K130274, K070758 | | Device Description: | The VersaPEEK™ Suture Anchor is manufactured completely from PEEK. This material composition minimizes post-operative imaging effects. The suture anchor is designed for ultimate mechanical properties (pullout strength, tensile strength, etc). The VersaPEEK™ Suture Anchor also has a variety of suture/suture tape configurations. | The VersaTap™ Suture Anchor is a self-tapping suture anchor mostly used as a medial row anchor in rotator cuff repair surgery. This anchor is ingeniously designed to combine the advantage of both PEEK and Titanium. The titanium tip allows for self-tapping ability whilst the majority of the anchor is manufactured from PEEK which minimizes post-operative imaging effects. | | Indications for Use: | The VersaPEEK™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaPEEK™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: • Shoulder: Rotator cuff repair, biceps tenodesis, SLAP repair, Bankart | The VersaTap™ Suture Anchor is intended to be used for soft tissue fixation during general orthopedic surgery. The VersaTap™ Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue and ligaments to bone/healthy tissue during tendon and ligament repairs, during procedures such as: • Shoulder: Rotator cuff repair, biceps tenodesis, | | | Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair. Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction. *The above-mentioned indications for use are identical to those of the predicate device, VersaTap™ Suture Anchor, cleared in submission K212381. | SLAP repair, Bankart repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Elbow: Tennis elbow repair Knee: Medial and lateral collateral ligament repair. Wrist: Scapholunate ligament reconstruction | | Relationship to the Device: | The subject and predicate devices (cleared in K212381) have the same intended use, materials, function, packaging, and similar design features. | | | Technological Differences: | The subject and predicate devices (cleared in K212381) have similar engineering designs and minor dimensional changes. The subject device has a reduced diameter compared to the predicate device (cleared in K212381). The subject device is also composed fully composed of PEEK whereas the predicate device (cleared in K212381) is composed of a PEEK body and a titanium tip. | | | Clinical Characteristics: | The subject and predicate device (cleared in K212381) are intended to be used for soft tissue fixation during general orthopedic surgery. | | | Technical Equivalence: | The subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and performance. | | | Mechanical Testing and Disclosure of Performance and Safety Deviation: | Substantial equivalence is supported by the results of mechanical testing including insertion torque and static pullout testing, and by justification for dynamic pullout (fatigue), component interconnection, and corrosion testing according to the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions'. Ortho-Design's suture anchors support safety and effectiveness and can be considered substantially equivalent to the predicate device (cleared in K212381). | | | Biocompatibility: | The subject and predicate devices (cleared in K212381) are manufactured using the same approved suppliers, manufacturing facilities, manufacturing processes, chemicals, materials, and cleaning processes. All manufacturing is conducted according to the processes defined by ISO 13485 and ISO 9001. All materials, processes, and cleaning agents used for the subject device have been used in the previously cleared device(s). Therefore biocompatibility of the subject device is substantially equivalent to the predicate device. The subject devices have been tested to be non-pyrogenic. | | | Quality Control Measures | For both the subject and predicate device (cleared in K212381) the methods, thresholds and criteria of the following are identical: • Sterility • Self-Life • Packaging • Pyrogenicity / Endotoxin Testing | | | Conclusion: | The subject device demonstrates substantial equivalence by non-clinical testing consisting of mechanical, biocompatibility, sterility, shelf-life, packaging and pyrogenicity tests and adheres to the minimum requirements set out in FDA's guidance document for Bone Anchors – Premarket Notification (510(k)) Submissions. | | | | Subject Device | Predicate Device (Cleared in K212381) | | Device Trade Name: | MicroTiTM Suture Anchor | MiniTiTM Suture Anchor (Cleared in K212381) | | Regulation Description: | Smooth or threaded metallic bone fixation fastener. | Smooth or threaded metallic bone fixation fastener. | | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue | Fastener, Fixation, Nondegradable, Soft Tissue | | Regulation Number: | 21 CFR 888.3040 | 21 CFR 888.3040 | | Device Classification: | Class II | Class II | | Product Code: | MBI…