X-Twist Biocomposite Suture Anchor

K232513 · Parcus Medical · MAI · Sep 18, 2023 · Orthopedic

Device Facts

• Record ID: K232513
• Device Name: X-Twist Biocomposite Suture Anchor
• Applicant: Parcus Medical
• Product Code: MAI · Orthopedic
• Decision Date: Sep 18, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications: Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

Device Story

X-Twist Biocomposite Suture Anchor is a bone fixation device for soft tissue-to-bone attachment. Device consists of a threaded, double-helical, cannulated biocomposite anchor (beta-tricalcium-phosphate and PLGA) with a PEEK anchor tip, provided pre-assembled on a driver. Used by surgeons in clinical settings (OR) to secure soft tissue during orthopedic repairs. Surgeon drills, awls, or taps bone; inserts anchor; secures sutures/tape to fix tissue. Output is mechanical fixation of soft tissue to bone, promoting healing. Benefits include stable tissue attachment during recovery. Provided sterile in 4.75mm, 5.5mm, or 6.25mm diameters.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via bench testing, including bacterial endotoxin testing per USP <85> and USP <161>.

Technological Characteristics

Materials: Beta-tricalcium-phosphate (β-TCP)/PLGA composite anchor, PEEK anchor tip, UHMWPE suture. Design: Threaded, double-helical, cannulated, inline fenestrations. Diameters: 4.75mm, 5.5mm, 6.25mm. Sterilization: Ethylene Oxide (EO). Shelf-life: 5 years. Single-use only.

Indications for Use

Indicated for attachment of soft tissue to bone in shoulder, foot/ankle, knee, and elbow procedures. Includes rotator cuff, SLAP, biceps tenodesis, AC separation, deltoid, lateral/medial stabilization, Achilles, ACL/PCL, MCL/LCL, patellar tendon, posterior oblique ligament, iliotibial band, quadriceps tendon, meniscal root, MPFL, and ulnar/radial collateral ligament repairs/reconstructions.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• X-Twist PEEK Suture Anchor (K221135)
• Twist AP (Biocomposite) Suture Anchor (K183501)

Reference Devices

• Arthrex SwiveLock (K101823)

Submission Summary (Full Text)

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September 18, 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.

Parcus Medical Calen Souther Manager, Regulatory Affairs 6455 Parkland Drive Sarasota, Florida 34243

Re: K232513

Trade/Device Name: X-Twist Biocomposite Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: August 18, 2023 Received: August 18, 2023

Dear Calen Souther:

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.

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

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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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sara S. Thompson -S

For

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232513

Device Name X-Twist Biocomposite Suture Anchor

#### Indications for Use (Describe)

The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:

Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction

Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> <path d="M2 2 L13 13 M2 13 L13 2" stroke="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial;"> <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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## 510(k) Summary

The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c).

| Date Prepared: | September 12, 2023 | | X-Twist Biocomposite Suture<br>Anchor | X-Twist PEEK Suture Anchor | Twist AP (Biocomposite) Suture<br>Anchor |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Parcus Medical, LLC.<br>6423 Parkland Dr.<br>Sarasota, FL 34243<br>USA | 510(k)<br>clearance | Subject Device | K221135 | K183501 |
| Official Correspondent: | Calen Souther, MS<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] | Manufacturer | Parcus Medical | Parcus Medical | Parcus Medical |
| Trade/Proprietary Name: | X-Twist Biocomposite Suture Anchor | Common Name | Fastener, fixation,<br>biodegradable, soft tissue | Fastener, fixation, non-<br>degradable, soft tissue | Fastener, fixation,<br>biodegradable, soft tissue |
| Common Name: | Fastener, fixation, biodegradable, soft tissue | Regulation | 21 CFR 888.3030 | 21 CFR 888.3040 | 21 CFR 888.3030 |
| Regulation Name: | Single/multiple component metallic bone fixation appliances and<br>accessories | Class Name | Single/multiple component<br>metallic bone fixation<br>appliances and accessories | Smooth or threaded metallic<br>bone fixation fastener | Single/multiple component<br>metallic bone fixation appliances<br>and accessories |
| Device Class: | Class II | Class | Class II | Class II | Class II |
| Regulation Number: | 21 CFR 888.3030 | Product Code | MAI | MBI | MAI |
| Product Code: | MAI | Indications for Use | The X-Twist Biocomposite<br>Suture Anchors are indicated<br>for attachment of soft tissue<br>to bone. These products are<br>intended for the following<br>indications: | The X-Twist PEEK Suture Anchors<br>are indicated for attachment of<br>soft tissue to bone. These<br>products are intended for the<br>following indications: | The Parcus Twist AP Suture<br>Anchors are indicated for the<br>attachment of soft tissue to<br>bone. This product is intended<br>for the following indications: |
| Predicate Device Information: | X-Twist PEEK Suture Anchor – K221135 - cleared May 19, 2022<br>Twist AP Suture Anchor - K183501 - cleared March 15, 2019 | | Shoulder: Rotator Cuff<br>Repair, SLAP Lesion Repair,<br>Biceps Tenodesis, Acromio-<br>Clavicular Separation Repair,<br>Deltoid Repair | Shoulder: Rotator Cuff Repair,<br>Acromioclavicular Separation<br>Repair, Bankart Lesion Repair,<br>Biceps Tenodesis, Capsular Shift<br>or Capsulolabral Reconstruction,<br>Deltoid Repair, SLAP Lesion<br>Repair. | Shoulder: Rotator Cuff Repair,<br>Acromioclavicular Separation<br>Repair, Bankart Lesion Repair,<br>Biceps Tenodesis, Capsular Shift<br>or Capsulolabral Reconstruction,<br>Deltoid Repair, SLAP Lesion<br>Repair. |
| Reference Device Information: | Arthrex SwiveLock – K101823 – cleared January 7, 2011 | | Foot/Ankle: Lateral<br>Stabilization, Medial<br>Stabilization, Achilles Tendon<br>Repair | Knee: Medial Collateral Ligament<br>Repair, Lateral Collateral<br>Ligament Repair, Posterior<br>Oblique Ligament Repair, Extra<br>Capsular Reconstruction,<br>Iliotibial Band Tenodesis,<br>Patellar Ligament and Tendon<br>Avulsion Repair. | Knee: Medial Collateral Ligament<br>Repair, Lateral Collateral<br>Ligament Repair, Posterior<br>Oblique Ligament Repair, Extra<br>Capsular Reconstruction,<br>Iliotibial Band Tenodesis,<br>Patellar Ligament and Tendon<br>Avulsion Repair. |
| Reason for 510(k) submission: | The purpose of this Special 510(k) is to obtain clearance for the X-Twist<br>Biocomposite Suture Anchor, as an extension of the Parcus Medical X-Twist<br>Suture Anchor portfolio, for use in the fixation of soft tissue to bone. | | Knee: Anterior Cruciate<br>Ligament Repair, Medial<br>Collateral Ligament Repair,<br>Lateral Collateral Ligament<br>Repair, Patellar Tendon<br>Repair, Posterior Oblique<br>Ligament Repair, Iliotibial<br>Band Tenodesis, Quadriceps<br>Tendon Repair, Meniscal<br>Root Repair, Secondary or<br>adjunct fixation for ACL/PCL<br>reconstruction or repair,<br>MPFL Repair/Reconstruction | Foot/Ankle: Lateral Stabilization,<br>Medial Stabilization, Midfoot<br>Reconstruction, Achilles Tendon<br>Repair, Hallux Valgus<br>Reconstruction, Metatarsal<br>Ligament Repair. | Foot/Ankle: Lateral Stabilization,<br>Medial Stabilization, Midfoot<br>Reconstruction, Achilles Tendon<br>Repair, Hallux Valgus<br>Reconstruction, Metatarsal<br>Ligament Repair. |
| Device Description: | The X-Twist Biocomposite Suture Anchor consists of the implants (anchor<br>and anchor tip) and the anchor driver assembly. The anchor and anchor tip<br>are provided assembled to the driver and sterile. The X-Twist Biocomposite<br>anchor is molded using a composite of $ β $ TCP (beta-tricalcium-phosphate)<br>and PLGA (poly-lactic-co-glycolic acid). The anchor tip is molded using PEEK<br>(polyetheretherketone). The anchor is fully threaded, double-helical,<br>cannulated, and has inline fenestrations on each quarter-turn face. The<br>anchor tip is retained on the driver via retention suture(s) or suture tape(s)<br>that are passed through the driver cannulation, looped over the retention<br>bridge within the tip, and returned out the proximal end of the driver handle | | Elbow: Ulnar/Radial<br>Collateral Ligament<br>Reconstruction, Lateral | Elbow: Tennis Elbow Repair,<br>Biceps Tendon Reattachment. | Elbow: Tennis Elbow Repair,<br>Biceps Tendon Reattachment. |
| | | Hand/Wrist: Scapholunate<br>Ligament Reconstruction, Ulnar | Hand/Wrist: Scapholunate<br>Ligament Reconstruction, Ulnar | | |

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and cleated. These devices are to be used with a drill, awl, and/or bone tap. The X-Twist Biocomposite Suture Anchors are provided sterile and in 4.75mm, 5.5mm, or 6.25mm diameters.

## Device Characteristics

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| | Epicondylitis Repair | or Radial Collateral Ligament<br>Reconstruction, TFCC. | or Radial Collateral Ligament<br>Reconstruction, TFCC. |
|------------------|-----------------------------------|--------------------------------------------------------|--------------------------------------------------------|
| Implant Material | B-TCP/PLGA<br>LT1- PEEK<br>UHMWPE | LT1- PEEK<br>UHMWPE | B-TCP/PLGA<br>UHMWPE |
| Single use only | Yes | Yes | Yes |
| Sterility | Sterile, EO | Sterile, EO | Sterile, EO |
| Shelf-life | 5-years | 5-years | 5-years |

## Non-clinical Testing

The non-clinical testing was conducted to evaluate the biocompatibility and performance of the subject device. The testing was performed using the same methods and protocols as that used for the predicate devices. The results of the testing were assessed against the results obtained with the predicate devices to determine substantial equivalency for design, performance, and safety.

Final devices were subjected to bacterial endotoxin testing in accordance with USP <85> and USP <161>.

| Test | Test Article | Negative<br>Control | Standard<br>Curve | PPC | Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Evaluation of<br>the USP<br>Limulus<br>Amebocyte<br>Lysate (LAL)<br>Test - Kinetic-<br>Turbidimetric<br>Method - as<br>an End-<br>Product<br>Endotoxin<br>Test | Ten (10)<br>disassembled<br>devices, each<br>submerged in<br>100ml LAL<br>reagent water<br>(LRW),<br>extracted in a<br>shaker<br>incubator at<br>37°C for one<br>(1) hour | Sterile<br>LRW | Control<br>Standard<br>Endotoxin<br>(CSE) at<br>10, 1.0,<br>0.1, 0.01<br>EU/ml | Test<br>article<br>spiked<br>with 0.1<br>EU/ml | Standard Curve<br>Correlation<br>Coefficient:<br>≥0.98<br><br>Slope of curve<br>between -0.400<br>and -0.100.<br><br>PPC: 50-200%<br><br>Test Article<br>Endotoxin<br>Concentration:<br>≤20 EU/device | Standard<br>Curve<br>Correlation<br>Coefficient:<br>1.00<br><br>Slope: -0.213<br><br>PPC: 173%<br><br>Test Article<br>Endotoxin<br>Concentration:<br><1.0<br>EU/device |

## Clinical Data

Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices.

## Conclusion

The X-Twist Biocomposite Suture Anchor is substantially equivalent to the predicate devices in which the design features, materials, packaging, sterility, shelf life, and intended uses are the same.

The testing data and comparisons of the technological characteristics within this submission demonstrate that the subject device is substantially equivalent to the predicate devices when used in accordance with the intended use.