BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

K251627 · Smith & Nephew, Inc. · MBI · Jun 25, 2025 · Orthopedic

Device Facts

• Record ID: K251627
• Device Name: BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
• Applicant: Smith & Nephew, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 25, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew BIORAPTOR® Suture Anchor is intended for the reattachment of soft tissue to bone. The Smith & Nephew BIORAPTOR® Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone.

Device Story

BIORAPTOR 2.3 PK and Curved 2.3 PK Suture Anchors are orthopedic fixation devices for reattaching soft tissue to bone. Devices consist of a PEEK suture anchor preassembled with UHMWPE sutures on a stainless steel/polycarbonate/ABS insertion tool. Used arthroscopically by orthopedic surgeons in clinical settings. Surgeon drills a hole in bone, inserts the anchor, and secures soft tissue using the attached sutures. Provides mechanical fixation to facilitate healing. Benefits include secure tissue-to-bone attachment for various orthopedic repairs. Packaging modified to thermoformed PETG trays with Tyvek lids.

Clinical Evidence

Bench testing only. Testing included packaging design verification, usability evaluation, and packaging material stability. All tests passed.

Technological Characteristics

Anchor: 100% PEEK. Suture: UHMWPE. Inserter shaft: 17-4 PH stainless steel. Inserter handle: Polycarbonate and ABS. Delivery: Arthroscopic, single-use. Sterilization: Ethylene Oxide (EtO). MR Safe. Shelf life: 5 years.

Indications for Use

Indicated for reattachment of soft tissue to bone in patients requiring hip capsule repair, acetabular labrum reattachment/reconstruction, shoulder capsular stabilization (Bankart, anterior instability, SLAP, capsular shift/reconstruction), acromioclavicular separation, deltoid, rotator cuff, or biceps tenodesis repairs. Also indicated for foot/ankle (hallux valgus, instability, Achilles, midfoot, metatarsal, bunionectomy), elbow/wrist/hand (biceps, collateral ligament, lateral epicondylitis), and knee (extra-capsular ligament, patellar realignment, IT band tenodesis) procedures.

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

• BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor (K152566)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 25, 2025

Smith & Nephew, Inc.
Crystal Treadway
Sr. Regulatory Affairs Specialist
150 Minuteman Road
Andover, Massachusetts 01810

Re: K251627

Trade/Device Name: BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38" ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38" ULTRABRAID (#2) Suture (cobraid blue)

Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: MBI
Dated: May 27, 2025
Received: May 28, 2025

Dear Crystal Treadway:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251627 - Crystal Treadway
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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" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

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K251627 - Crystal Treadway
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devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, MS
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
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)

K251627

Device Name

BIORAPTOR® 2.3 PK Suture Anchor w/ ULTRABRAID® (#2) Suture (cobraid blue);
BIORAPTOR® 2.3 PK Suture Anchor w/ ULTRABRAID® (#2) Suture (cobraid black);
BIORAPTOR® 2.3 PK Suture Anchor w/ ULTRABRAID® (#2) Suture (white);
BIORAPTOR® CURVED 2.3 PK Suture Anchor w/ ONE 38" ULTRABRAID® (#2) Suture (cobraid black);
BIORAPTOR® CURVED 2.3 PK Suture Anchor w/ ONE 38" ULTRABRAID® (#2) Suture (cobraid blue)

Indications for Use (Describe)

The Smith & Nephew BIORAPTOR® Suture Anchor is indicated for the reattachment of soft tissue to bone for the following indications:

Hip:
Hip Capsule Repair
-Acetabular labrum reattachment/reconstruction

Shoulder:
Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis

Foot and Ankle:
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy

Elbow, Wrist, and Hand:
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair

Knee:
Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament

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Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
Iliotibial band tenodesis

Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchors are indicated for the reattachment of soft tissue to bone for the following indications:

Shoulder:
Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis

Foot and Ankle:
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy

Elbow, Wrist, and Hand:
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair

Knee:
Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs
- Vastus medialis obliquus advancement
Iliotibial band tenodesis

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.

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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:

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Paperwork Reduction Act (PRA) Staff
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"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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Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
Massachusetts, USA
T:+ 1 978 749 1000
T:+ 1 800 343 8386 (USA toll free)
www.smith-nephew.com
SmithNephew

# 510(k) Summary

Prepared: 25 June 2025

| Submitter Information | Contact Information |
| --- | --- |
| Smith & Nephew, Inc.
Endoscopy Division
150 Minuteman Road
Andover, MA 01810 | Mrs. Crystal Treadway
Sr. Regulatory Affairs Specialist
[e-mail] |
| Device Name & Classification | |
| --- | --- |
| Proprietary Name | BIORAPTOR® 2.3 PK Suture Anchor w/ ULTRABRAID® (#2) Suture (cobraid blue)
BIORAPTOR® 2.3 PK Suture Anchor w/ ULTRABRAID® (#2) Suture (cobraid black)
BIORAPTOR® 2.3 PK Suture Anchor w/ ULTRABRAID® (#2) Suture (white)
BIORAPTOR® CURVED 2.3 PK Suture Anchor w/ ONE 38" ULTRABRAID® (#2) Suture (cobraid black)
BIORAPTOR® CURVED 2.3 PK Suture Anchor w/ ONE 38" ULTRABRAID® (#2) Suture (cobraid blue) |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, biodegradable, soft tissue; fastener, fixation, nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MBI |
| Panel | Orthopedic |

# Legally Marketed Predicate Device

The Smith & Nephew BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:

| Description | Submission Number | Clearance Date |
| --- | --- | --- |
| BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor | K152566 | 02 Dec 2015 |

# Device Description

The Smith & Nephew BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchors are fixation devices intended to provide secure attachment of soft tissue to bone. The devices consist of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. The BIORAPTOR Curved 2.3 PK Suture Anchors are preassembled to a flexible insertion device.

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# Intended Use

The Smith & Nephew BIORAPTOR® Suture Anchor is intended for the reattachment of soft tissue to bone.

The Smith & Nephew BIORAPTOR® Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone.

# Indications for Use

The Smith & Nephew BIORAPTOR® Suture Anchor is indicated for the reattachment of soft tissue to bone for the following indications:

Hip:
Hip Capsule Repair
-Acetabular labrum reattachment/reconstruction

Shoulder:
Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis

Foot and Ankle:
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy

Elbow, Wrist, and Hand:
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair

Knee:
Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
Iliotibial band tenodesis

The Smith & Nephew BIORAPTOR® Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder:
Capsular stabilization
- Bankart repair

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- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions

Acromioclavicular separation repairs

Deltoid repairs

Rotator cuff tear repairs

Biceps tenodesis

Foot and Ankle:

Hallux valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Bunionectomy

Elbow, Wrist, and Hand:

Biceps tendon reattachment

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Knee:

Extra-capsular repairs:

- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament

Patellar realignment and tendon repairs

- Vastus medialis obliquous advancement

Iliotibial band tenodesis

## Technological Characteristics

| | BIORAPTOR 2.3 PK Suture Anchors and the BIORAPTOR Curved 2.3 PK Suture Anchors (Subject Device) | BIORAPTOR 2.3 PK Suture Anchors and the BIORAPTOR Curved 2.3 PK Suture Anchors (Predicate Device; K152566) |
| --- | --- | --- |
| Intended Use | The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone | Same |
| Indications for Use | The Smith & Nephew Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip Hip Capsule Repair -Acetabular labrum reattachment/reconstruction Shoulder: Capsular stabilization - Bankart repair | Same |

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- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis

Foot and Ankle
Hallux valgus repairs
Medial or lateral instability
repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy

Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair

Knee
Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
Iliotibial band tenodesis

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture
Anchor is intended for the reattachment of soft tissue to bone
for the following indications:

Shoulder:
Capsular stabilization
- Bankart repair
- Anterior shoulder instability
- SLAP lesion repairs
- Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis

Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy

Elbow, Wrist, and Hand
Biceps tendon reattachment

{10}

| | Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair

Knee
Extra-capsular repairs:
- Medial collateral ligament
- Lateral collateral ligament
- Posterior oblique ligament
Patellar realignment and tendon repairs
- Vastus medialis obliquous advancement
Iliotibial band tenodesis | |
| --- | --- | --- |
| Delivery Method | Arthroscopic | Same |
| How Supplied | Packaged in thermoformed PETG tray with a PETG retainer and sealed Tyvek lid, Sterile (EtO), Single Use | Same function to maintain sterile barrier as with the predicate device. The subject device is supplied with the same sterilization method and single use labeling as predicate device. |
| Shelf Life | 5 years | Same |
| MR Compatibility | MR Safe | Same |
| Anchor Material | 100% PEEK (polyetheretherketone) | Same |
| Suture Material | UHMWPE (ultra high molecular weight polyethylene) | Same |
| Inserter Shaft Materials | 17-4 PH Stainless Steel | Same |
| Inserter Handle Materials | Polycarbonate and ABS | Same |
| Method of Anchor Insertion | Inserted into a predrilled hole | Same |
| Accessories | Nonsterile, reusable and sterile drills and drill guides | Same |

The proposed BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor is identical in design to the legally marketed BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor (K152566). The modifications to the legally marketed predicate device BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor (K152566) include changing the packaging from a Tyvek pouch to thermoformed PETG Trays and retainers and Tyvek Lid. The subject device has the same intended use, method of sterilization, materials, and indications for use as the predicate device. The difference in packaging between the subject device and predicate device are minor and raise no new questions of safety of effectiveness.

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## Performance Data

Non-clinical testing was completed on the subject device for the proposed packaging modification, and the device met all required specifications for each test. Testing included Packaging Design Verification, Usability Evaluation, and Packaging Material Stability. A summary of test acceptance criteria and results have been provided. Results for all tests passed.

## Conclusion

The substantial equivalence of the BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor is based on identical indications for use, identical design, operational principles, material biocompatibility and composition of the devices, and performance to the predicate devices listed above. Modifications in packaging do not raise additional questions of safety or effectiveness compared to the predicate device. Based on the similarities, BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchor is substantially equivalent to its predicate.