X-Twist PEEK Suture Anchor

K221135 · Parcus Medical, LLC · MBI · May 19, 2022 · Orthopedic

Device Facts

• Record ID: K221135
• Device Name: X-Twist PEEK Suture Anchor
• Applicant: Parcus Medical, LLC
• Product Code: MBI · Orthopedic
• Decision Date: May 19, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The X-Twist PEEK Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications: Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Device Story

X-Twist PEEK Suture Anchor consists of implantable PEEK anchor and tip preloaded on driver; retention sutures/tapes secure tip to driver. Surgeon performs clockwise rotation to advance fully threaded anchor into prepared bone socket; provides fixation point for soft tissue repair. Used in OR by orthopedic surgeons for various soft tissue-to-bone repairs (e.g., rotator cuff, ligament reconstruction). Device facilitates secure tissue attachment to bone, aiding healing and structural stability.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including cycle loading, elongation, insertion torque, and anchor pullout force, alongside bacterial endotoxin testing per USP <85> and USP <161>.

Technological Characteristics

Materials: PEEK and UHMWPE. Fully threaded anchor design. Sterile, EO sterilized. Single-use. Mechanical fixation via threaded advancement into bone socket.

Indications for Use

Indicated for attachment of soft tissue to bone in shoulder, knee, foot/ankle, elbow, and hand/wrist procedures requiring soft tissue fixation.

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

• Parcus Slik Anchor (K170327)
• Parcus Twist PEEK Suture Anchor (K120942)

Submission Summary (Full Text)

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May 19, 2022

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Parcus Medical LLC Calen Souther, MS Senior Specialist, Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243

Re: K221135

Trade/Device Name: X-Twist PEEK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: April 15, 2022 Received: April 19, 2022

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

For:

Laura C. Rose, 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K221135

Device Name

X-Twist PEEK Suture Anchor

#### Indications for Use (Describe)

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

Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avul Un Report Li

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

| Type of Use (Select one or both, as applicable) | <span> <span style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> <span> 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: | May 17, 2022 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Parcus Medical, LLC.<br>6423 Parkland Dr.<br>Sarasota, FL 34243<br>USA |
| Official Correspondent: | Calen Souther, MS<br>Senior Specialist, Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Trade/Proprietary Name: | X-Twist PEEK Suture Anchor |
| Common Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | MBI |
| Predicate Device Information: | Parcus Slik Anchor - K170327 - cleared March 30, 2017<br>Parcus Twist PEEK Suture Anchor – K120942 – cleared April 20, 2012 |
| Reason for 510(k) submission: | The purpose of this Special 510(k) is to obtain clearance for the X-Twist PEEK<br>Suture Anchor, as an extension of the Parcus suture anchor portfolio, for<br>use in the fixation of soft tissue to bone. |
| Description of Device: | The X-Twist PEEK Suture Anchor consists of an implantable anchor and<br>anchor tip that are provided assembled to a driver. Retention suture(s) or<br>suture tapes(s) are preloaded through the driver cannulation to secure the<br>anchor tip onto the driver shaft. The anchor tip can be loaded with<br>additional suture(s) or suture tapes(s) if needed for the intended surgical<br>procedure. Clockwise rotation of the driver allows for advancement of the<br>fully threaded anchor and anchor tip into the prepared bone socket to serve<br>as the point of fixation for soft tissue repair. |

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# Device Characteristics

| | X-Twist PEEK Suture Anchor | Parcus Slik Anchor<br>Parcus Twist PEEK Suture Anchor |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>clearance | Subject Device | K170327<br>K120942 |
| Manufacturer | Parcus Medical | Parcus Medical |
| Common Name | Fastener, Fixation, Non-degradable, soft<br>tissue | Fastener, Fixation, Non-degradable, soft tissue |
| Regulation | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Class Name | Smooth or threaded metallic bone fixation<br>fastener | Smooth or threaded metallic bone fixation<br>fastener |
| Class | Class II | Class II |
| Product Code | MBI | MBI |
| Indication for Use | The X-Twist PEEK Suture Anchors are<br>indicated for attachment of soft tissue to<br>bone. These products are intended for the<br>following indications: | The Parcus Slik Anchors and Twist PEEK Suture<br>Anchors are indicated for attachment of soft<br>tissue to bone. These products are intended for<br>the following indications: |
| | Shoulder: Rotator Cuff Repair,<br>Acromioclavicular Separation Repair, Bankart<br>Lesion Repair, Biceps Tenodesis, Capsular<br>Shift or Capsulolabral Reconstruction, Deltoid<br>Repair, SLAP Lesion Repair. | Shoulder: Rotator Cuff Repair, Acromioclavicular<br>Separation Repair, Bankart Lesion Repair, Biceps<br>Tenodesis, Capsular Shift or Capsulolabral<br>Reconstruction, Deltoid Repair, SLAP Lesion<br>Repair. |
| | Knee: Medial Collateral Ligament Repair,<br>Lateral Collateral Ligament Repair, Posterior<br>Oblique Ligament Repair, Extra Capsular<br>Reconstruction, Iliotibial Band Tenodesis,<br>Patellar Ligament and Tendon Avulsion<br>Repair. | Knee: Medial Collateral Ligament Repair, Lateral<br>Collateral Ligament Repair, Posterior Oblique<br>Ligament Repair, Extra Capsular Reconstruction,<br>lliotibial Band Tenodesis, Patellar Ligament and<br>Tendon Avulsion Repair. |
| | Foot/Ankle: Lateral Stabilization, Medial<br>Stabilization, Midfoot Reconstruction, Achilles<br>Tendon Repair, Hallux Valgus Reconstruction,<br>Metatarsal Ligament Repair. | Foot/Ankle: Lateral Stabilization, Medial<br>Stabilization, Midfoot Reconstruction, Achilles<br>Tendon Repair, Hallux Valgus Reconstruction,<br>Metatarsal Ligament Repair. |
| | Elbow: Tennis Elbow Repair, Biceps Tendon<br>Reattachment. | Elbow: Tennis Elbow Repair, Biceps Tendon<br>Reattachment. |
| | Hand/Wrist: Scapholunate Ligament<br>Reconstruction, Ulnar or Radial Collateral<br>Ligament Reconstruction, TFCC. | Hand/Wrist: Scapholunate Ligament<br>Reconstruction, Ulnar or Radial Collateral<br>Ligament Reconstruction, TFCC. |
| Implant Material | LT1- PEEK<br>UHMWPE | LT1- PEEK<br>UHMWPE |
| Single use only | Yes | Yes |
| Sterility | Sterile, EO | Sterile, EO |
| Shelf-life | 5-years | 5-years |

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## Non-clinical Testing

Benchtop testing was performed to evaluate cycle loading and elongation, insertion torque, and anchor pullout force. The testing was performed using the same methods and protocols as that used for the predicate devices. The results of the testing met the defined acceptance criteria and were assessed against the results obtained with the predicate devices to determine substantial equivalency for design and performance.

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

| Test | Test Article | Negative<br>Control | Standard<br>Curve | PPC | Acceptance<br>Criteria | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| USP <85> and<br><161><br>Inhibition/<br>Enhancement<br>Single Lot<br>Validation for<br>the Kinetic<br>Turbidimetric<br>Limulus<br>Amebocyte<br>Lysate (LAL)<br>Test | Ten (10)<br>disassembled<br>devices, each<br>submerged in<br>1000ml LAL<br>reagent water<br>(LRW),<br>extracted at<br>room<br>temperature<br>for one (1)<br>hour | Sterile<br>LRW | Control<br>Standard<br>Endotoxin<br>(CSE) at<br>1.23,<br>0.25,<br>0.05, 0.01<br>EU/ml | Test<br>article<br>spiked<br>with<br>0.05<br>EU/ml | Standard<br>Curve<br>Correlation<br>Coefficient:<br>≥0.98<br><br>Neg. Control<br>Onset Time:<br>Onset time ><br>lowest Cal<br>Standard<br><br>PPC: 50-200%<br><br>Test Article<br>Endotoxin<br>Concentration:<br>≤20 EU/device | Standard Curve<br>Correlation<br>Coefficient:<br>1.00<br><br>Neg. Control<br>Onset Time:<br>>6000 seconds<br><br>PPC: 58%<br><br>Test Article<br>Endotoxin<br>Concentration:<br><1 EU/device |

The results of the bacterial endotoxin test met the requirements of the FDA-recognized standards USP <85> and USP <161>.

### Clinical Data

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

### Conclusion

The X-Twist PEEK Suture Anchor is substantially equivalent to the predicate devices in which the basic 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.