OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

K212912 · B-One Ortho, Corp. · MAI · Nov 4, 2021 · Orthopedic

Device Facts

• Record ID: K212912
• Device Name: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
• Applicant: B-One Ortho, Corp.
• Product Code: MAI · Orthopedic
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OneFix Biocomposite Anchors: The OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. OneFix Biocomposite Small Anchors: The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate 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 Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair OneFix All Suture Anchors: The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue. OneFix Biocomposite Interference Screws: The OneFix Biocomposite Interference Screws are indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction. OneFix Cannula System: The OneFix Cannula System is intended for introduction of instrumentation through a portal for surgical procedure.

Device Story

System comprises biocomposite anchors, all-suture anchors, interference screws, and cannula system; used for soft tissue-to-bone fixation in orthopedic procedures. Anchors/screws manufactured from PLGA copolymer and B-TCP; sutures from UHMWPE/PET. Cannula/trocar made of polycarbonate. Devices implanted by surgeons in OR using provided drivers/insertion tools. Anchors stabilize soft tissue (ligaments, tendons, joint capsules) to bone during healing. Cannula provides portal for surgical instrumentation. System provides mechanical fixation; no software or AI components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Anchors/screws: PLGA copolymer and B-TCP. Sutures: UHMWPE/PET. Cannula/trocar: Polycarbonate. Anchors are cannulated with eyelets; interference screws are threaded. Single-use, sterile. No software or electronic components.

Indications for Use

Indicated for soft tissue-to-bone fixation in orthopedic procedures including shoulder, foot/ankle, knee, elbow, hand, wrist, and hip. Specific procedures include rotator cuff, Bankart, SLAP, biceps tenodesis, ligament repairs (ACL/PCL, MCL, LCL), and tendon reattachments. Used in arthroscopic or open surgery.

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

• Fixone Biocomposite Anchors (K192484)
• Fixone Biocomposite Small Anchors (K192032)
• Fixone All Suture Anchors (K192709)
• Fixone Interfernece Screws (K193497)
• JOINIX Cannula System (K162070)

Submission Summary (Full Text)

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November 4, 2021

Image /page/0/Picture/1 description: The image shows the logo for 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 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.

b-ONE ORTHO, Corp Allison Gecik Associate Director, Regulatory Affairs 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07927

# Re: K212912

Trade/Device Name: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI, HWC, HRX Dated: September 10, 2021 Received: September 13, 2021

Dear Allison Gecik:

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,

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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## Indications for Use

#### 510(k) Number (if known)

#### K212912

#### Device Name

OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

#### Indications for Use (Describe)

The OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotor Cuff Repair, Bankart Repair, BLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

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

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot. ankle, knee, hand, wrist, elbow, shoulder, and hip.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular repair, Acetabular Labral repair

(Continued)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known)

#### K212912

#### Device Name

OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

### Indications for Use (Describe)

(p.2/2)

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In con junction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.

The OneFix Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The OneFix Cannula System is introduction of instrumentation through a portal for surgical procedure.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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### TRADITIONAL 510(K) SUMMARY As required by 21 CFR 807.92

### Submitter Information:

| Submitter's Name: | b-ONE ORTHO, Corp. | |
|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Address: | 3 Wing Drive<br>Suite 259<br>Cedar Knolls, NJ 07927 | |
| Telephone: | 866-276-4538 | |
| Contact Person: | Allison Gecik | |
| Telephone: | 973-965-8940 | |
| Date Prepared: | September 10, 2021 | |
| Proprietary Name: | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix<br>All Suture Anchors, OneFix Interference Screws, OneFix Cannula System | |
| Classification: | Class II | |
| Classification Panel: | Orthopedic | |
| Common Name: | Biodegradable Orthopedic Bone Screw<br>Screw, Fixation, Bone<br>Non-absorbable Suture Anchor<br>Arthroscope | |
| Product Code(s): | MAI; HWC; MBI; HRX | |
| | Classification Name(s): | Regulation<br>Number |
| | Single/multiple component metallic bone fixation<br>appliances and accessories | 888.3030 |
| | Smooth or threaded metallic bone fixation fastener | 888.3040 |
| | Arthroscope | 888.1100 |
| Legally Marketed<br>Predicate Devices to<br>Which Substantial<br>Equivalence is Claimed: | Fixone Biocomposite Anchors; K192484<br>Fixone Biocomposite Small Anchors; K192032<br>Fixone All Suture Anchors; K192709<br>Fixone Interfernece Screws; K193497<br>JOINIX Cannula System; K162070 | |

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### Intended Use:

OneFix Biocomposite Anchors: The OneFix Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

OneFix Biocomposite Small Anchors: The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate 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

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Hip: Capsular repair, Acetabular Labral repair

OneFix All Suture Anchors: The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.

OneFix Biocomposite Interference Screws: The OneFix Biocomposite Interference Screws are indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

OneFix Cannula System: The OneFix Cannula System is intended for introduction of instrumentation through a portal for surgical procedure.

### Device Description/Technological Characteristics:

The OneFix Biocomposite Anchors consist of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 96 model codes over 4 families. The anchors widths range from 3.0mm through 6.5mm and lengths of 11.9mm through 16.8mm.

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The OneFix Biocomposite Small Anchors consist of cannulated anchors with an eyelet. They are preloaded on an insertion device. The anchor is manufactured from PLGA copolymer and B-TCP. A nonabsorbable suture manufactured from cobraided UHMWPE/PET is inserted into the anchor and then implanted using the provided driver. There are 9 model codes corresponding to variations of sutures with anchor dimensions (11.9mm x 2.4mm x 3.0mm).

The OneFix All Suture Anchors consist of one "fixed suture" and 2 or 3 non-absorbable sutures. The non-absorbable suture is manufactured from UHMWPE and PET fibers. The OneFix All Suture Anchor is implanted using its self-punching option and are pre-loaded on a handled insertion device. They come in 14 various model codes.

The OneFix Biocomposite Interference Screws are inserted into the bone tissue and the external thread is screw shaped and the inside of the screw is start shaped. The screws are manufactured from PLGA copolymer and ß-TCP. There are 36 model codes with outside diameter ranging from 7-12mm and 20-35mm lengths.

The OneFix Cannula Systems is intended to puncture through tissue to make a pathway for surgical instruments during surgery. It consists of a cannula and a trocar made of polycarbonate. There are 3 types of this product: threaded, smooth and all smooth and comes in 72 model codes with inside diameter of 4.3mm through 8.1mm and lengths of 84mm through 130mm.

All implant components are provided sterile and are designated as single use. The system also includes

the reusable surgical instruments required for implantation.

### Comparison of Technological Characteristics

The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The OneFix Biocomposite/All Suture Anchors and Interference Screws and Cannula Systems and the predicate devices share the following characteristics:

- Materials of construction
- . Manufacturing processes
- Sizes offered
- Product design for shape and macrostructures ●
- Sterilization methods ●

### Conclusion

The information provided above supports that the OneFix Biocomposite/All Suture Anchors and Interference Screws and Cannula Systems are as safe and effective as the predicate devices with the same intended use. The OneFix Biocomposite/All Suture Anchors and Interference Screws and Cannula Systems are substantially equivalent to the predicate devices.