CEPTRE® Knotted UHMWPE Suture PEEK Anchor

K231033 · Healthium Medtech Limited · MBI · Jan 4, 2024 · Orthopedic

Device Facts

• Record ID: K231033
• Device Name: CEPTRE® Knotted UHMWPE Suture PEEK Anchor
• Applicant: Healthium Medtech Limited
• Product Code: MBI · Orthopedic
• Decision Date: Jan 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications: 1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction. 2. Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy. 3. Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis. 4. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers. 5. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair. 6. Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.

Device Story

Device consists of PEEK screw or wedge anchors preloaded with UHMWPE sutures or tapes on a disposable inserter. Used by surgeons in orthopedic procedures to fix soft tissue to bone. Anchors provide mechanical fixation; surgeon inserts device into bone to secure tissue, facilitating healing. Supplied sterile for single use.

Clinical Evidence

Bench testing only. Includes static pull-out testing, cyclical loading, and drive-in torque testing. Biocompatibility testing performed (sensitization, intracutaneous reactivity, systemic toxicity, cytotoxicity, implantation). Bacterial endotoxin testing per USP <85> and shelf-life/packaging integrity testing conducted.

Technological Characteristics

Materials: PEEK anchor, UHMWPE suture/tape. Design: Threaded (screw) or tap-in (wedge) anchors. Sterilization: EtO. Single-use, disposable inserter assembly.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot, ankle, knee, hand, wrist, elbow, and hip surgical procedures. Applicable to various ligament, tendon, and labral repairs/reconstructions.

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

• Arthrex Corkscrew Suture Anchors (K143745)
• Arthrex SutureTak Suture Anchors (K140855)

Submission Summary (Full Text)

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January 4, 2024

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.

Healthium Medtech Limited Pankaj Dawar Deputy General Manager Regulatory Affair 472-D, 13th Cross, 4th Phase, Peenya Industrial Area Bangalore, Karnataka 560058 India

Re: K231033

Trade/Device Name: CEPTRE® Knotted UHMWPE Suture PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 2, 2023 Received: December 4, 2023

Dear Pankaj Dawar:

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/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.

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 OS 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 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/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 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-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.

Digitally signed by Jesse
Jesse Muir -S Muir-S
Date: 2024.01.04 10:17:30
-05'00'

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

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Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231033

### Device Name

CEPTRE® Knotted UHMWPE Suture PEEK Anchor

## Indications for Use (Describe)

The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:

- 1. Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
- 2. Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy.
- 3. Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
- 4. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
- 5. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
- 6. Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.

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

| <div> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|

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Image /page/4/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/4/Picture/1 description: The image contains the text 'K231033' at the top. Below that is a logo for 'Healthium'. The logo consists of the word 'Healthium' in a bold, sans-serif font, with a stylized graphic to the right. The graphic appears to be two overlapping circles, one blue and one orange, with a white cross shape imposed over them.

# 1. 510(k) Summary

#### 1.1. Submitter Information:

| Application Correspondent: | PANKAJ DAWAR |
|-----------------------------|-----------------------------------------------------|
| | Healthium Medtech Limited |
| | 472-D, 13th Cross, 4th Phase, |
| | Peenya Industrial Area, |
| | Bangalore Karnataka 560058, India |
| Phone: | [phone] |
| E-mail: | [e-mail] |
| Specification Developer: | Healthium Medtech Limited |
| | 472-D, 13th Cross, 4th Phase, |
| | Peenya Industrial Area, |
| | Bangalore, Karnataka 560058, India |
| Phone: | +91 - 80 - 41868000 |
| Contact Person: | PANKAJ DAWAR |
| E-mail: | [e-mail] |
| Date Prepared: | 03-01-2024 |
| 1.2. Device Identification: | |
| Device Trade Name: | CEPTRE® Knotted UHMWPE Suture PEEK Anchor. |
| Device Common Name: | Non-Absorbable Suture Anchor |
| Classification Name: | Smooth or threaded metallic bone fixation fastener. |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 888.3040 |

MBI Product Code:

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Image /page/5/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/5/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one orange and one blue, with a white plus sign in the center.

#### 1.3. Predicate Devices:

Table 1 - List of Predicate Devices

| Device Name | 510(k) Number | S.No | Parameters | Arthrex<br>Suture<br>(K143745) | Corkscrew<br>Anchors | Arthrex<br>Suture Anchors<br>(K140855) | CEPTRE®<br>Knotted<br>UHMWPE<br>Suture PEEK<br>Anchor<br>(Subject Device) |
|----------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Arthrex Corkscrew Suture Anchors | K143745 | 1. | Manufacturer | Arthrex, Incorporated | Arthrex, Incorporated | Arthrex, Incorporated | Healthium<br>Medtech Limited |
| Arthrex SutureTak Suture Anchors | K140855 | 2. | Product Code | MBI | | MAI (Classification<br>Product Code)<br>MBI (Subsequent Product<br>Code) | MBI |
| 3. | Regulation<br>Number | 21 CFR 888.3040 | | 21 CFR 888.3030 | 21 CFR 888.3040 | | |
| 4. | Classification | Class II | | Class II | Class II | | |
| 5. | Intended Use | The Arthrex Corkscrew<br>suture anchors are<br>intended to be used for<br>fixation of suture (soft<br>tissue) to bone in the<br>shoulder, foot/ankle,<br>hip, knee, hand/wrist,<br>and elbow in the<br>following procedures:<br>• Shoulder: Rotator<br>Cuff Repair, Bankart<br>Repair, SLAP<br>Lesion Repair,<br>Biceps Tenodesis,<br>Acromio-Clavicular<br>Separation Repair,<br>Deltoid Repair,<br>Capsular Shift or<br>Capsulolabral<br>Reconstruction.<br>• Foot/Ankle:<br>Lateral<br>Stabilization,<br>Medial<br>Stabilization,<br>Achilles<br>Tendon Repair,<br>Hallux Valgus<br>Reconstruction,<br>Mid-foot<br>Reconstruction,<br>Metatarsal<br>Ligament<br>Repair/Tendon<br>Repair and<br>Bunionectomy. | | The Arthrex SutureTak<br>suture anchors are<br>intended to be used for<br>suture (soft tissue)<br>fixation to bone in the<br>foot, ankle, knee, hand,<br>wrist, elbow, shoulder,<br>and hip.<br>• Shoulder: Rotator Cuff<br>Repair, Bankart Repair,<br>SLAP Lesion Repair,<br>Biceps Tenodesis,<br>Acromio-Clabicular<br>Separation Repair,<br>Deltoid Repair,<br>Capsular Shift or<br>Capsulolabral<br>Reconstruction<br>• Foot/Ankle: Lateral<br>Stabilization, Medial<br>Stabilization, Achilles<br>Tendon Repair,<br>Metatarsal Ligament<br>Repair, Hallux Valgus<br>reconstruction, digital<br>tendon transfers, Mid-<br>foot reconstruction<br>• Knee: Medial Collateral<br>Ligament Repair,<br>Lateral Collateral<br>Ligament Repair,<br>Patellar Tendon Repair,<br>Posterior Oblique<br>Ligament Repair,<br>Iliotibial Band<br>Tenodesis | The CEPTRE®<br>Knotted<br>UHMWPE Suture<br>PEEK Anchor are<br>indicated in<br>surgical<br>procedures for soft<br>tissue fixation to<br>bone in the foot,<br>ankle, knee, hand,<br>wrist, elbow,<br>shoulder and hip<br>for the following<br>indications:<br>1. Shoulder:<br>Rotator Cuff<br>Repair,<br>Bankart<br>Repair, SLAP<br>Lesion Repair,<br>Biceps<br>Tenodesis,<br>Acromio-<br>Clavicular<br>Separation<br>Repair,<br>Deltoid Repair<br>Capsular Shift<br>or<br>Capsulolabral<br>Reconstruction<br>• 2. Foot/Ankle:<br>Lateral<br>Stabilization,<br>Medial<br>stabilization | | |

#### Device Description 1.4.

The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.

#### 1.5. Indications for Use

Indications for Use

The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:

- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, 1. Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
- Foot/Ankle: Lateral Stabilization. Medial stabilization. Achilles Tendon repair. Hallux Valgus 2. reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral 3. ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
- 4. Hand/Wrist: Scapholunate ligament reconstruction. Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
- న్. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
- Hip: Acetabular labral repair, Capsular repair and gluteus medius repair. 6.

#### 1.6. Comparison of Technological Characteristics

The fundamental scientific technology, materials of construction and mechanism of operation are similar between the subject device CEPTRE® Knotted UHMWPE Suture PEEK Anchor and the predicate devices. Table 2 summarizes the comparison of technological characteristics between the subject and predicate device.

Table 2 - Substantial Equivalence Table

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Image /page/6/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" replaced by a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, lighter font.

Image /page/6/Picture/1 description: The image contains the word "Healthium" in a blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles. The bottom circle is blue, and the top circle is orange.

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Image /page/7/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is in a bold, sans-serif font, with the "O" in "Sironix" being a red circle. Below "Sironix" is the text "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/7/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one blue and one orange. The blue circle is in the foreground and the orange circle is in the background.

| S.No | Parameters | Arthrex<br>Suture<br>(K143745) | Corkscrew<br>Anchors | Arthrex<br>Suture Anchors<br>(K140855) | SutureTak<br>CEPTRE®<br>Knotted<br>UHMWPE<br>Suture PEEK<br>Anchor<br>(Subject Device) | |
|------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Knee: Anterior<br>Cruciate Ligament<br>Repair, Medial<br>Collateral<br>Ligament Repair,<br>Lateral Collateral<br>Ligament Repair,<br>Patellar Tendon<br>Repair, Posterior<br>Oblique Ligament<br>Repair, and<br>Illiotibial Band<br>Tenodesis. Hand/Wrist:<br>Scapholunate<br>Ligament<br>Reconstruction,<br>Ulnar or Radial<br>Collateral<br>Ligament<br>Reconstruction. Elbow: Biceps<br>Tendon<br>Reattachment,<br>Tennis Elbow<br>Repair, Ulnar<br>or Radial<br>Collateral<br>Ligament<br>Reconstruction,<br>Lateral<br>Epicondylitis<br>repair. Hip: Capsular<br>repair,<br>acetabular<br>labral repair,<br>gluteus medius<br>repair. | | Hand/Wrist:<br>Scapholunate<br>Ligament<br>Reconstruction,<br>Carpal Ligament<br>Reconstruction,<br>Repair/Reconstruction<br>of collateral<br>ligaments, Repair of<br>Flexor and Extensor<br>Tendons at the PIP,<br>DIP, and MCP joints<br>for all digits, digital<br>tendon transfers Elbow: Biceps<br>Tendon Reattachment,<br>Ulnar or Radial<br>Collateral Ligament<br>Reconstruction Hip: Capsular repair,<br>Acetabular Labral<br>repair | Achilles<br>Tendon repair,<br>Hallux Valgus<br>reconstruction,<br>Mid-foot<br>reconstruction,<br>Metatarsal<br>ligament<br>repair/tendon<br>repair, Digital<br>tendon<br>transfers and<br>Bunionectomy<br>3. Knee: Anterior<br>Cruciate<br>Ligament<br>Repair, Medial<br>Collateral<br>ligament<br>repair, Lateral<br>collateral<br>ligament<br>repair, Patellar<br>Tendon<br>Repair,<br>Posterior<br>Oblique<br>Ligament<br>Repair and<br>Iliotibial band<br>tenodesis.<br>4. Hand/Wrist:<br>Scapholunate<br>ligament<br>reconstruction,<br>Ulnar or<br>Radial<br>Collateral<br>Ligament<br>Reconstruction<br>, Carpal<br>Ligament<br>Reconstruction<br>,<br>Repair/Recons<br>truction of<br>collateral<br>ligaments, | |
| S.No | Parameters | Arthrex<br>Suture<br>(K143745) | Corkscrew<br>Anchors | Arthrex<br>Suture Anchors<br>(K140855) | CEPTRE®<br>Knotted<br>UHMWPE<br>Suture PEEK<br>Anchor<br>(Subject Device) | |
| 6. | Anchor<br>Material | PEEK | PEEK | PEEK | PEEK | |
| 7. | Suture / Tape<br>Material | UHWMPE<br>or<br>a<br>polyblend<br>of<br>UHMWPE<br>and<br>polyester | | UHWMPE or a polyblend<br>of UHWMPE and<br>polyester | Suture-UHMWPE<br>USP#2<br>Tape- UHMWPE<br>1.5mm Round-<br>Flat-Round | |
| 8. | Design<br>Feature | The Arthrex Corkscrew<br>is fully threaded suture<br>anchors<br>designed for maximum<br>fixation strength and<br>simple<br>insertion. An internal<br>drive mechanism is<br>combined with<br>a unique eyelet to allow<br>for continuous | | The SutureTak Suture<br>Anchors are threaded<br>made up of PEEK<br>material, designed for<br>maximum fixation<br>strength.<br>The implant is provided<br>preloaded on an inserter<br>and may include eyelets<br>which are preloaded with<br>various types of suture, | Repair of<br>Flexor and<br>Extensor<br>Tendons at the<br>PIP, DIP, and<br>MCP joints for<br>all digits,<br>Digital tendon<br>transfers.<br>5. Elbow: Biceps<br>tendon<br>reattachment,<br>Tennis Elbow<br>Repair, Ulnar<br>or Radial<br>collateral<br>ligament<br>reconstruction,<br>and lateral<br>Epicondylitis<br>repair.<br>6. Hip:<br>Acetabular<br>labral repair,<br>Capsular repair<br>and gluteus<br>medius repair. | |
| | | | | | with the suture(s),<br>tape(s) or suture-<br>tape combinations | |
| S.No | Parameters | Arthrex<br>Suture<br>(K143745) | Corkscrew<br>Anchors | Arthrex Suture Anchors<br>(K140855) | SutureTak | CEPTRE®<br>Knotted<br>UHMWPE<br>Suture PEEK<br>Anchor<br>(Subject Device) |
| | | threads along the entire<br>length of the anchor.<br>The anchors<br>are loaded with<br>FiberWire sutures or<br>tapes to provide<br>superior repair strength. | | | | made up of<br>UHMWPE on the<br>disposable Sterile<br>Inserters. |
| 9. | Specifications<br>and<br>Dimensions | PEEK<br>Corkscrew FT<br>Suture Anchor,<br>4.5 mm x 14<br>mm w/two #2<br>FiberWire (1<br>Blue, 1<br>White/Black) PEEK<br>Corkscrew FT<br>Suture Anchor,<br>4.75 mm x 14<br>mm w/two 1.3<br>mm<br>SutureTapes<br>(White/Black,<br>White/Blue) PEEK<br>Corkscrew FT<br>Suture Anchor,<br>4.75 mm x 14<br>mm w/two 1.3<br>mm<br>SutureTapes<br>(White/Black,<br>White/Blue) PEEK<br>Corkscrew FT<br>Suture Anchor,<br>5.5 mm x 14.7<br>mm w/three #2<br>FiberWire | | SutureTak Suture<br>Anchor 2mm x<br>12mm #1<br>FiberWire SutureTak Suture<br>Anchor 2.4 mm x<br>12mm #2<br>FiberWire SutureTak Suture<br>Anchor 3 mm x<br>14mm #2<br>Fiber Wire SutureTak Suture<br>Anchor 3 mm x<br>14mm #2<br>FiberWire, qty. 2 | | Wedge anchor:<br>USP #2 Suture<br>Loaded-<br>2.5mm, Length<br>12mm USP #2 Double<br>Sutures<br>Loaded-<br>2.8mm, Length<br>12mm 1.5mm Double<br>Tapes Loaded-<br>2.8mm, Length<br>12mm Screw anchor:<br>USP #2 Suture<br>& 1.5mm Tape<br>Loaded-<br>4.8mm, Length<br>15mm USP #2 Double<br>Sutures<br>Loaded-<br>4.8mm, Length<br>15mm 1.5mm Double<br>Tapes Loaded-<br>4.8mm, Length<br>15mm USP #2 Suture<br>&1.5mm Tape<br>Loaded-<br>5.5mm, Length<br>15mm USP #2 Double<br>Sutures<br>Loaded-<br>5.5mm, Length<br>15mm |
| S.No | Parameters | Arthrex<br>Suture<br>(K143745) | Corkscrew<br>Anchors | Arthrex<br>Suture Anchors<br>(K140855) | CEPTRE®<br>Knotted<br>UHMWPE<br>Suture PEEK<br>Anchor<br>(Subject Device) | |
| | | | PEEK<br>Corkscrew FT<br>Suture Anchor,<br>6.5 mm x 14.7<br>mm w/two #2<br>FiberWire | | 1.5mm Double<br>Tapes Loaded-<br>5.5mm, Length<br>15mm USP #2 Triple<br>Sutures<br>Loaded-<br>5.5mm, Length<br>15mm | |
| 10 | Single<br>Use/Reuse | Single Use | | Single Use | Single Use | |
| 11 | Shelf Life | 5 Years | | 5 Years | 5 Years | |
| 12 | Sterilization<br>Method | EtO | | EtO | EtO | |
| 13 | Performance<br>Data | Insertion testing, Static<br>pull-out Testing,<br>Fatigue testing | | Tensile testing<br>Fatigue testing | Drive In Torque<br>Pull-Out Test<br>Cyclical Loading | |
| 14 | Safety Data | No Data Available | | No Data Available | Skin<br>Sensitization Intracutaneous<br>reactivity Material<br>Mediated<br>Pyrogenicity Acute Systemic<br>Toxicity In vitro<br>cytotoxicity Bone<br>Implantation Muscle<br>Implantation Bacterial<br>Endotoxin | |

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Image /page/8/Picture/0 description: The image shows the logo for Sironix. The word "Sironix" is written in a sans-serif font, with the "O" in "Sironix" being a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller font.

Image /page/8/Picture/1 description: The image shows the logo for Healthium. The word "Healthium" is written in a blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one blue and one orange, with a white plus sign in the center.

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Image /page/9/Picture/0 description: The image shows the logo for Sironix. The word "Sironix" is written in a sans-serif font, with the "O" in "Sironix" being a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller font.

Image /page/9/Picture/1 description: The image shows the logo for Healthium. The word "Healthium" is written in blue, with the "H" capitalized. To the right of the word is a graphic of two overlapping circles, one blue and one orange. The blue circle has a white plus sign in the middle.

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Image /page/10/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "ArthroscopySolutions" in a smaller font.

Image /page/10/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one blue. A white plus sign is visible in the blue circle.

#### 1.7. Summary of Performance Data

The CEPTRE® Knotted UHMWPE Suture PEEK Anchor and Predicate device underwent tests to determine their pull-out strength, cyclical loading and drive in torque test. Results demonstrated that the CEPTRE® Knotted UHMWPE Suture PEEK Anchor performs statistically equivalent to the predicate device.

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Image /page/11/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/11/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one dark blue. A white plus sign is superimposed over the circles.

#### 1.8. Non-Clinical Testing

The Static pull out testing and cyclic loading were performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.

Bacterial endotoxin per USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications.

Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling.

#### 1.9. Conclusion

There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate devices (Arthrex Corkscrew Suture Anchors and Arthrex SutureTak Suture Anchors) in design, Intended use, Indications for use, function, Sterilization method, Shelf Life, and operational principles. From the data available we can justify that the CEPTRE® Knotted UHMWPE Suture PEEK Anchor is as safe, and as effective and performs the same indications for use as that of already marketed predicate device identified.