BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN

K121018 · Smith & Nephew, Inc. · MBI · Jun 22, 2012 · Orthopedic

Device Facts

• Record ID: K121018
• Device Name: BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
• Applicant: Smith & Nephew, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors are intended for use in the attachment or 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 repair/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 ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis

Device Story

Suture anchors used for soft tissue-to-bone fixation; implanted by surgeons during orthopedic procedures. Device consists of anchor body and attached suture; functions by securing soft tissue to bone to facilitate healing. Used in hip, shoulder, foot/ankle, elbow/wrist/hand, and knee surgeries. Expansion of indications to include acetabular labrum reconstruction. No changes to design or materials from predicate devices.

Clinical Evidence

No clinical data provided. Substantial equivalence based on mechanical bench testing (insertion strength, pull-out strength, suture sliding) and published articles supporting the additional indication.

Technological Characteristics

Suture anchors for soft tissue fixation. No changes in design or materials from cleared predicates. Mechanical fixation principle. Class II devices.

Indications for Use

Indicated for soft tissue-to-bone attachment/reattachment in hip (labrum), shoulder (capsular stabilization, rotator cuff, biceps), foot/ankle (ligament/tendon repairs, bunionectomy), elbow/wrist/hand (ligament/tendon repairs), and knee (extra-capsular repairs, patellar realignment). For prescription use.

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® 2.9 Suture Anchors (K053344)
• BIORAPTOR® 2.3 PK Suture Anchors (K071586)
• OSTEORAPTOR® Suture Anchors (K082215)
• BIORAPTOR® Knotless Suture Anchors (K093428)

Submission Summary (Full Text)

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# JUN 2 2 2 2012

## 510(k) Summary Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® PK 2.3, OSTEORAPTOR®, and BIORAPTOR® Knotless Suture Anchors

| Submitted by: | Smith & Nephew, Inc.<br>150 Minuteman Road<br>Andover, MA 01810 |
|---------------|-----------------------------------------------------------------|
|---------------|-----------------------------------------------------------------|

| Date of Summary: | April 3, 2012 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person and Address: | John Connor, Regulatory Affairs Specialist<br>T [phone] F [phone] |
| Name of Device(s): | Smith & Nephew, Inc. BIORAPTOR® 2.9 Suture Anchor<br>Smith & Nephew, Inc. BIORAPTOR® 2.3 PK Suture<br>Anchor<br>Smith & Nephew, Inc OSTEORAPTOR® Suture Anchor<br>Smith & Nephew, Inc. BIORAPTOR® Knotless Suture<br>Anchor |
| Common Name: | Fastener, Fixation, Biodegradable, Soft Tissue<br>Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Classification Name and<br>Reference: | 21 CFR 888.3030 Single/multiple component metallic<br>bone fixation appliances and accessories<br><br>21 CFR 888.3040 Smooth or threaded metallic bone<br>fixation fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | MAI, MBI |

#### Device Description

Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.

#### Technological Characteristics

There have been no major changes in design or materials in the subject suture anchors since their market clearance. As such, the technological characteristics of the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK OSTEORAPTOR®, and BIORAPTOR® Knotless Suture Anchors have not changed.

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#### Intended Use

The Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors are intended for use in the attachment or 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 repair/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 ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis

#### Substantial Equivalence Information

The substantial equivalence of the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors is based on similarities in indications for use, design features, operational principles, and material composition to the predicate devices listed in the table below. As there have been no significant changes to the design of the subject suture anchors, and the expansion of indications for use to include labral reconstruction introduces no additional risk, Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence.

| Manufacturer | Description | Submission<br>Number | Clearance<br>Date |
|----------------------|------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | BIORAPTOR® 2.9 Suture Anchors | K053344 | 02/23/2006 |
| Smith & Nephew, Inc. | BIORAPTOR® 2.3 PK Suture Anchors | K071586 | 08/17/2007 |
| Smith & Nephew, Inc. | OSTEORAPTOR® Suture Anchors | K082215 | 11/03/2008 |
| Smith & Nephew, Inc. | BIORAPTOR® Knotless Suture Anchors | K093428 | 12/17/2009 |

2

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## Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to expand the indications for use for the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. Based on the similarities to the predicate components and published articles supporting the additional indication, the devices are substantially equivalent to their predicates.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings, and a wavy line representing its tail.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 2 2012

Smith and Nephew, Inc. % Mr. John Connor 7135 Goodlett Farms Parkway Cordova, Tennesee 38016

Re: K121018

Trade/Device Name: BIORAPTOR™ 2.9, BIORAPTOR™ 2.3 PK, OSTEORAPTOR™, and BIORAPTOR™ Knotless Suture Anchors

Regulation Number: 21 CFR 888.3040

Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: April 3, 2012 Received: April 4, 2012

Dear Mr. Connor:

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. 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.

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 (reporting of medical

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### Page 2 - Mr. John Connor

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Eil Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Premarket Notification Indications for Use Statement

510(k) Number (if known): _ K121018

Device Name:

BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors

Indications for Use:

The Smith & Nephew Suture Anchors are 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
- Anterior shoulder instability .
- SLAP lesion repairs .
- Capsular shift or capsulolabral . reconstructions

Acromioclavicular separation repairs Deltoid repairs

Rotator Cuff 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

Knee

.

Extra-capsular repairs

reconstructions

Elbow, Wrist, and Hand

Lateral epicondylitis repair

Biceps tendon reattachment

Ulnar or radial collateral ligament

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

Patellar realignment and tendon repairs

- Vastus medialis obliquous ● advancement
Iliotibial band tenodesis

Ast

(Division 'lign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K121018 510(k) Number

AND/OR Prescription Use __ X (Part 21 CFR 801.109) l

Over-the-Counter Use _ (Optional Format 1-2-96)

# (Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)