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 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 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 MicroTiTM Suture Anchor is a small screw-in suture anchor used in a variety of small-joint applications. Despite its small diameter, the specially engineered thread combines with cortical bone to provide tremendous pull-out strength.

The VersaLat™ Ti Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

The VersaLat™ Suture Anchor is a knotless-/suture anchor. This titanium screw-in anchor can be combined with the VersaTap™ Suture Anchor in double rotator cuff repair surgery. Flexibility is what differentiates this anchor from its competitors with surgeons being able to fixate any number of sutures/tapes (K150438) by adjusting the size of the characteristic front loop. The extra suture provided by this anchor can also be used for the fixation of the biceps tendon or any ligament fragments.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for several suture anchor devices (VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. It does not involve AI/ML technology, imaging, or human reader studies.

Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of an AI/ML study, "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are not applicable to this type of submission.

The study described here is a mechanical and biocompatibility assessment of medical devices, not an AI/ML performance study.

Here's an adaptation of the requested information based on the provided document:

Acceptance Criteria and Study for Suture Anchors (Non-AI/ML Medical Device)

The provided submission, K242296, for the VersaTap™, VersaPEEK™, MicroTi™, VersaLat™ Ti, and VersaLat™ Suture Anchors, is a 510(k) Premarket Notification. The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove performance of an AI/ML algorithm or derive clinical effectiveness from human reader studies.

The acceptance criteria and supporting studies are based on non-clinical testing to ensure the new devices are as safe and effective as their predicates.

1. Table of Acceptance Criteria (for Non-Clinical Testing) and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Acceptance Criteria (Implicit)	Reported Device Performance and Conclusion
Mechanical Performance	Insertion Torque Testing	Performance comparable to or better than the predicate device to ensure proper implantation and stability.	Substantial equivalence supported by the results of mechanical testing, including insertion torque. The devices support safety and effectiveness. (Details not explicitly quantified in this summary, but determined to be acceptable).
	Static Pullout Testing	Performance comparable to or better than the predicate device to ensure adequate fixation strength.	Substantial equivalence supported by the results of mechanical testing, including static pullout. The devices support safety and effectiveness. (Details not explicitly quantified in this summary, but determined to be acceptable).
	Dynamic Pullout (Fatigue)	Justification for not performing dynamic pullout testing explicitly, demonstrating it's unnecessary to prove equivalence or safety.	Justification for dynamic pullout (fatigue) testing provided according to FDA guidance.
	Component Interconnection	Assurance of proper and secure connection of device components.	Justification for component interconnection provided.
	Corrosion Testing	Materials and design ensure resistance to corrosion in the body environment.	Justification for corrosion testing provided.
Biocompatibility	Material Composition	Materials must be biocompatible and safe for implantation, consistent with previously cleared devices. Performance must be non-pyrogenic.	Subject devices manufactured using the same approved suppliers, manufacturing facilities, processes, chemicals, materials, and cleaning processes as predicate devices. All materials and processes have been used in previously cleared devices. Tested to be non-pyrogenic. Biocompatibility is substantially equivalent.
Sterility	Sterility	Devices must achieve and maintain sterility for their shelf-life.	Methods, thresholds, and criteria for sterility are identical to the predicate device.
Shelf-Life	Shelf-Life	Devices must maintain their properties and safety over their intended shelf-life.	Methods, thresholds, and criteria for shelf-life are identical to the predicate device.
Packaging	Packaging Integrity	Packaging must protect the device and maintain sterility until use.	Methods, thresholds, and criteria for packaging are identical to the predicate device.
Quality Control	Manufacturing QA	Manufacturing processes adhere to established quality systems (ISO 13485, ISO 9001).	All manufacturing is conducted according to processes defined by ISO 13485 and ISO 9001. Methods, thresholds, and criteria for quality control measures are identical to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This is not an AI/ML study with a "test set" of data in the traditional sense. It's a medical device submission based on non-clinical bench testing and comparison to predicates.

Sample Size:
- For mechanical testing (insertion torque, static pullout), specific sample sizes would have been used per test standards (e.g., ASTM, ISO). These exact numbers are not detailed in the summary document but are implied to be sufficient for demonstrating equivalence.
- For biocompatibility, the assessment relies on the prior clearance of the same materials and processes in predicate devices. New testing (e.g., non-pyrogenic) would involve a sample size relevant to that specific test.
Data Provenance: The data provenance is from bench laboratory testing conducted by Ortho-Design (Pty) Ltd in South Africa. It is prospective testing of the new devices and comparison to the known performance and characteristics of the already cleared predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This is not applicable as this is not an AI/ML study involving human interpretation of data where "ground truth" is established by experts in an annotation or diagnostic capacity.
The "ground truth" in this context is established by engineering and biocompatibility standards and the documented performance of legally marketed predicate devices, as determined by mechanical and chemical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or diagnostic "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to AI/ML software where the aim is to evaluate how AI assistance impacts human reader performance (e.g., in medical imaging diagnosis). This submission pertains to physical medical devices (suture anchors) and their mechanical/biocompatibility characteristics.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for these suture anchors is established through:

Engineering Standards: Adherence to recognized national and international standards for mechanical testing of bone anchors (e.g., those referenced in the FDA Guidance: 'Bone Anchors - Premarket Notification (510(k)) Submissions').
Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (cleared in K212381), which serve as the benchmark for equivalence.
Material Biocompatibility Data: Established safety profiles of the materials (PEEK, Titanium) as used in previously cleared medical devices, and specific biocompatibility testing (e.g., pyrogenicity) performed on the subject devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study involving a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no "training set," there is no ground truth established for it.

Summary

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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"

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(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

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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

· 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

· 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

· 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.

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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.

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.

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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) Ltd17 Dely RoadHazelwood, Pretoria, 0081 SouthAfrica
Date:	26 August 2024
Contact Person:Telephone:Email:	Dian Peach, Managing Director(+27) 12 807 1902dianpeach@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 metallicbone fixation fastener.	Smooth or threaded metallicbone 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 bySmith & Nephew	K061665; K173788;K063453, K130274, K070758
Device Description:	The VersaTap™ SutureAnchor is a self-tapping sutureanchor. This anchor isdesigned to combine theadvantages of both PEEK andTitanium. The titanium tipmakes the product self-tapping,whilst the majority of theanchor is manufactured fromPEEK to minimize post-operative imaging effects.	The VersaTap™ SutureAnchor is a self-tappingsuture anchor mostly used asa medial row anchor inrotator cuff repair surgery.This anchor is ingeniouslydesigned to combine theadvantage of both PEEK andTitanium. The titanium tipallows for self-tappingability whilst the majority ofthe anchor is manufacturedfrom PEEK which minimizespost-operative imagingeffects.
Indications for Use:	The VersaTap™ Suture Anchoris intended to be used for softtissue fixation during generalorthopedic surgery. TheVersaTap™ Suture Anchor isintended for use in arthroscopicor open surgical approaches forfixation of soft tissue andligaments to bone/healthytissue during tendon andligament repairs, duringprocedures such as:• Shoulder: Rotator cuffrepair, biceps tenodesis,SLAP repair, Bankartrepair• Foot/Ankle: LateralStabilization, MedialStabilization, AchillesTendon Repair, HalluxValgus• Elbow: Tennis elbow repair• Knee: Medial and lateralcollateral ligament repair.• Wrist: Scapholunateligament reconstruction.	The VersaTap™ SutureAnchor is intended to beused for soft tissue fixationduring general orthopedicsurgery. The VersaTap™Suture Anchor is intended foruse in arthroscopic or opensurgical approaches forfixation of soft tissue andligaments to bone/healthytissue during tendon andligament repairs, duringprocedures such as:• Shoulder: Rotator cuffrepair, biceps tenodesis,SLAP repair, Bankartrepair• Foot/Ankle: LateralStabilization, MedialStabilization, AchillesTendon Repair, HalluxValgus• Elbow: Tennis elbowrepair• Knee: Medial and lateralcollateral ligament repair.• Wrist: Scapholunateligament reconstruction
Relationship to theDevice:	The subject and predicate devices (cleared in K212381)have the same intended use, materials,packaging, and similar design features.	function.
TechnologicalDifferences:	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 andDisclosure ofPerformance and SafetyDeviation:	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 ControlMeasures	For both the subject and predicate device (cleared in K212381)the methods, thresholds and criteria of the following areidentical:Sterility Self-Life Packaging Pyrogenicity / Endotoxin Testing
Conclusion:	The subject device demonstrates substantial equivalence bynon-clinical testing consisting of mechanical, biocompatibility,sterility, shelf-life, packaging and pyrogenicity tests andadheres to the minimum requirements set out in FDA'sguidance document for Bone Anchors – PremarketNotification (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 metallicbone fixation fastener.	Smooth or threaded metallicbone 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 bySmith & Nephew	K061665; K173788;K063453, K130274, K070758
Device Description:	The VersaPEEK™ SutureAnchor is manufacturedcompletely from PEEK. Thismaterial compositionminimizes post-operativeimaging effects. The sutureanchor is designed for ultimatemechanical properties (pulloutstrength, tensile strength, etc).The VersaPEEK™ SutureAnchor also has a variety ofsuture/suture tapeconfigurations.	The VersaTap™ SutureAnchor is a self-tappingsuture anchor mostly used asa medial row anchor inrotator cuff repair surgery.This anchor is ingeniouslydesigned to combine theadvantage of both PEEK andTitanium. The titanium tipallows for self-tappingability whilst the majority ofthe anchor is manufacturedfrom PEEK which minimizespost-operative imagingeffects.
Indications for Use:	The VersaPEEK™ SutureAnchor is intended to be usedfor soft tissue fixation duringgeneral orthopedic surgery.The VersaPEEK™ SutureAnchor is intended for use inarthroscopic or open surgicalapproaches for fixation of softtissue and ligaments tobone/healthy tissue duringtendon and ligament repairs,during procedures such as:• Shoulder: Rotator cuffrepair, biceps tenodesis,SLAP repair, Bankart	The VersaTap™ SutureAnchor is intended to beused for soft tissue fixationduring general orthopedicsurgery. The VersaTap™Suture Anchor is intended foruse in arthroscopic or opensurgical approaches forfixation of soft tissue andligaments to bone/healthytissue during tendon andligament repairs, duringprocedures such as:• Shoulder: Rotator cuffrepair, 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 theDevice:	The subject and predicate devices (cleared in K212381) have the same intended use, materials, function, packaging, and similar design features.
TechnologicalDifferences:	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 andDisclosure ofPerformance and SafetyDeviation:	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 ControlMeasures	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 metallicbone fixation fastener.	Smooth or threaded metallicbone 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:	Depuy Mitek QuickAnchor(K071257)	K061665; K111000; K173788;K063453, K200523, K070758
Device Description:	The MicroTiTM SutureAnchor is a small screw-insuture anchor used in avariety of small-jointapplications. Despite its smalldiameter, the speciallyengineered thread combineswith cortical bone to providetremendous pull-out strength.	The MiniTiTM Suture Anchoris a small screw-in sutureanchor used in a variety ofsmall-joint applications.Despite its small diameter, thespecially engineered threadcombines with cortical bone toprovide tremendous pull-outstrength.
Indications for Use:	The MicroTiTM SutureAnchor is intended to be usedfor soft tissue fixation duringgeneral orthopedic surgery.The MicroTiTM SutureAnchor is intended for use inarthroscopic or open surgicalapproaches for fixation ofsoft tissue and ligaments tobone/healthy tissue duringtendon and ligament repairs,during procedures such as:• Elbow: Ulnar/MedialCollateral LigamentRepair.• Foot/Ankle: AchillesTendon Repair, LateralStabilization, MedialStabilization, AchillesTendon Repair, Mid-footReconstruction, HalluxValgus Reconstruction,	The MiniTiTM Suture Anchoris intended to be used for softtissue fixation during generalorthopedic surgery. TheMiniTiTM Suture Anchor isintended for use inarthroscopic or open surgicalapproaches for fixation of softtissue and ligaments tobone/healthy tissue duringtendon and ligament repairs,during procedures such as:• Elbow: Ulnar/MedialCollateral Ligament Repair• Foot/Ankle: AchillesTendon Repair, LateralStabilization, MedialStabilization, AchillesTendon Repair, Mid- footReconstruction, HalluxValgus Reconstruction,
	Metatarsal Ligament Repair.• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral Ligament Reconstruction.*The above-mentioned indications for use are identical to those of the predicate device, MiniTi™ Suture Anchor, cleared in submission K212381.	Metatarsal Ligament Repair.• Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/ Radial Collateral 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).
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 safety 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) aremanufactured by the same approved suppliers, and use thesame manufacturing facilities, manufacturing processes,chemicals, materials, and cleaning processes. Allmanufacturing is conducted according to the processesdefined by ISO 13485 and ISO 9001. All materials,processes, and cleaning agents used for the subject devicehave been used in the previously cleared device(s). Thereforebiocompatibility of the subject device is substantiallyequivalent to the predicate device.The subject devices have been tested to be non-pyrogenic.
Quality ControlMeasures	For both the subject and predicate device (cleared in K212381)the methods, thresholds and criteria of the following areidentical:• Sterility• Self-Life• Packaging• Pyrogenicity / Endotoxin Testing
Conclusion:	The subject device demonstrates substantial equivalence bynon-clinical testing consisting of mechanical, biocompatibility,sterility, shelf-life, packaging and pyrogenicity tests andadheres to the minimum requirements set out in FDA'sguidance document for Bone Anchors – PremarketNotification (510(k)) Submissions.
	Subject Device	Predicate Device(Cleared in K212381)
Device Trade Name:	VersaLat™ Ti Suture Anchor	VersaLat™ Suture Anchor(Cleared in K212381)
Regulation Description:	Smooth or threaded metallicbone fixation fastener.	Smooth or threaded metallicbone 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
Predicate Device:	VersaLat™ Suture Anchor(K212381), manufactured byOrtho-Design (Pty) Ltd	DePuy Mitek Healix AdvanceKnotless BR Anchor(K130917)
Reference Device:	K151342 - ArthrexSwivelock Anchors	K190728; K203495; K130274 K070758
Device Description:	The VersaLat™ Ti SutureAnchor is a knotless-/sutureanchor. This titanium screw-in anchor can be combinedwith the VersaTap™ SutureAnchor in double rotator cuffrepair surgery. Flexibility iswhat differentiates thisanchor from its competitorswith surgeons being able tofixate any number ofsutures/tapes (K150438) byadjusting the size of thecharacteristic front loop. Theextra suture provided by thisanchor can also be used forthe fixation of the bicepstendon or any ligamentfragments.	The VersaLat™ Suture Anchoris an innovative knotless-/suture anchor inspired by atop orthopedic shouldersurgeon. This PEEK screw-inanchor can be combined withthe VersaTap™ Suture Anchorin double rotator cuff repairsurgery. Flexibility is whatdiffers this anchor from itscompetitors with surgeonsbeing able to fixate anynumber of sutures/tapes(K150438) by adjusting thesize of the characteristic frontloop. The extra sutureprovided by this anchor canalso be used for the fixation ofthe biceps tendon or anyligament fragments
Indications for Use:	The VersaLat™ Ti SutureAnchor is intended to use forfixation of soft tissue andligaments to bone/healthytissue during tendon andligament repairs, duringprocedures such as:• Shoulder: Rotator CuffRepair, Biceps Tenodesis	The VersaLat™ Suture Anchoris intended to use for fixationof soft tissue and ligaments tobone/healthy tissue duringtendon and ligament repairs,during procedures such as:• Shoulder: Rotator CuffRepair, Biceps Tenodesis
Relationship to the Device:	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.	Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis.
Technological Differences:	The subject and predicate devices (cleared in K212381) have the same intended use, materials, function, packaging, and similar design features.The subject and predicate devices (cleared in K212381) have similar engineering designs and minor dimensional changes. The subject device has a reduced diameter and an increased length compared to the predicate device (cleared in K212381). The subject devices also features a titanium threaded body whereas the predicate device features a PEEK threaded body.
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:	Both the subject and predicate devices (cleared in K212381) have similar designs, development methods, principles of operations and safety 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) aremanufactured by the same approved suppliers, and use thesame manufacturing facilities, manufacturing processes,chemicals, materials, and cleaning processes. Allmanufacturing is conducted according to the processes definedby ISO 13485 and ISO 9001. All materials, processes, andcleaning agents used for the subject device have been used inthe previously cleared device(s). Therefore biocompatibility ofthe subject device is substantially equivalent to the predicatedevice.The subject devices have been tested to be non-pyrogenic.
Quality ControlMeasures	For both the subject and predicate device (cleared in K212381)the methods, thresholds and criteria of the following areidentical:Sterility Self-Life Packaging Pyrogenicity / Endotoxin Testing
Conclusion:	The subject device demonstrates substantial equivalence bynon-clinical testing consisting of mechanical, biocompatibility,sterility, shelf-life, packaging and pyrogenicity tests andadheres to the minimum requirements set out in FDA'sguidance document for Bone Anchors – PremarketNotification (510(k)) Submissions.
	Subject Device	Predicate Device(Cleared in K212381)
Device Trade Name:	VersaLat™ Suture Anchor	VersaLat™ Suture Anchor(Cleared in K212381)
Regulation Description:	Smooth or threaded metallicbone fixation fastener.	Smooth or threaded metallicbone 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
Predicate Device:	VersaLat™ Suture Anchor(K212381), manufactured byOrtho-Design (Pty) Ltd	DePuy Mitek Healix AdvanceKnotless BR Anchor(K130917)
Reference Device:	K151342 - ArthrexSwivelock Anchors	K190728; K203495; K130274 K070758
Device Description:	The VersaLat™ SutureAnchor is a knotless-/sutureanchor. This titanium screw-in anchor can be combinedwith the VersaTap™ SutureAnchor in double rotator cuffrepair surgery. Flexibility iswhat differentiates thisanchor from its competitorswith surgeons being able tofixate any number ofsutures/tapes (K150438) byadjusting the size of thecharacteristic front loop. Theextra suture provided by thisanchor can also be used forthe fixation of the bicepstendon or any ligamentfragments.	The VersaLat™ Suture Anchoris an innovative knotless-/suture anchor inspired by atop orthopedic shouldersurgeon. This PEEK screw-inanchor can be combined withthe VersaTap™ Suture Anchorin double rotator cuff repairsurgery. Flexibility is whatdiffers this anchor from itscompetitors with surgeonsbeing able to fixate anynumber of sutures/tapes(K150438) by adjusting thesize of the characteristic frontloop. The extra sutureprovided by this anchor canalso be used for the fixation ofthe biceps tendon or anyligament fragments
Indications for Use:	The VersaLat™ SutureAnchor is intended to use forfixation of soft tissue andligaments to bone/healthytissue during tendon andligament repairs, duringprocedures such as:• Shoulder: Rotator Cuff	The VersaLat™ Suture Anchoris intended to use for fixationof soft tissue and ligaments tobone/healthy tissue duringtendon and ligament repairs,during procedures such as:• Shoulder: Rotator CuffRepair, 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.	Elbow: Biceps Tendon Reattachment, Ulnar/Radial Collateral Ligament Reconstruction. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, and Iliotibial Band Tenodesis.
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 and an increased 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 safety 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) aremanufactured by the same approved suppliers, and use thesame manufacturing facilities, manufacturing processes,chemicals, materials, and cleaning processes. Allmanufacturing is conducted according to the processes definedby ISO 13485 and ISO 9001. All materials, processes, andcleaning agents used for the subject device have been used inthe previously cleared device(s). Therefore biocompatibility ofthe subject device is substantially equivalent to the predicatedevice.The subject devices have been tested to be non-pyrogenic.
Quality ControlMeasures	For both the subject and predicate device (cleared in K212381)the methods, thresholds and criteria of the following areidentical: Sterility Self-Life Packaging Pyrogenicity / Endotoxin Testing
Conclusion:	The subject device demonstrates substantial equivalence bynon-clinical testing consisting of mechanical, biocompatibility,sterility, shelf-life, packaging and pyrogenicity tests andadheres to the minimum requirements set out in FDA'sguidance document for Bone Anchors – PremarketNotification (510(k)) Submissions.

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Table 3: DEVICE B – VersaPEEK™ Suture Anchor

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Table 4: DEVICE C – MicroTi™ Suture Anchor

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Table 5: DEVICE D – VersaLat™ Ti Suture Anchor

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Table 6: DEVICE E – VersaLat™ Suture Anchor

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Regulation Number and Section

N/A