HARPOON SUTURE ANCHOR

K071816 · Biomet Sports Medicine, Inc. · HWC · Sep 20, 2007 · Orthopedic

Device Facts

• Record ID: K071816
• Device Name: HARPOON SUTURE ANCHOR
• Applicant: Biomet Sports Medicine, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are: Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair Wrist - Scapholunate ligament reconstruction Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction Hip - Capsular Repair (acetabular labral repair)

Device Story

Harpoon® Suture Anchor is a metallic fixation device used for soft tissue reattachment to bone. Device consists of stainless steel or titanium body with a collar designed to resist pullout; preloaded with polyethylene suture. Available in two sizes. Used by surgeons in orthopedic procedures (shoulder, wrist, elbow, knee, foot, ankle, hip). Device is implanted into bone to secure soft tissue, facilitating healing and structural repair. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing.

Technological Characteristics

Materials: stainless steel or titanium. Design: anchor with collar for pullout resistance. Preloaded with polyethylene suture. Two sizes available. Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for soft tissue reattachment procedures in shoulder, wrist, elbow, knee, foot, ankle, and hip. Includes repairs for ligaments, tendons, and capsules (e.g., rotator cuff, Achilles, Bankart, SLAP, biceps tenodesis).

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

• Harpoon® Suture Anchor (K973775)
• BioRaptor™ (K053344)
• Metal Screw Anchor (Currently Ti Screw) (K012503)

Submission Summary (Full Text)

{0}------------------------------------------------

Ko71816

page of

## 510(k) Summary

SEP 2 0 2007

Preparation Date: June 29, 2007

Applicant/Sponsor: Biomet Sports Medicine (Formerly known as Arthrotek, Inc.)

Contact Person: Elizabeth Wray

Proprietary Name: Harpoon® Suture Anchor

Common Name: Suture Anchor

#### Classification Name:

- � MBI (888.3040): Fastener, fixation, nondegradable, soft tissue
- HWC (888.3040): Screw, fixation bone ♥

#### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| Device | Harpoon® Suture Anchor | BioRaptor™ | Metal Screw Anchor<br>(Currently Ti Screw) |
|---------------|------------------------|----------------|--------------------------------------------|
| Manufacturer | Biomet Sports Medicine | Smith & Nephew | Biomet Sports Medicine |
| 510(k) Number | K973775 | K053344 | K012503 |

Device Description: The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.

### Indications for Use/Intended Use:

Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

SSL, 1939 - Commen

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iiiotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

२-१

{1}------------------------------------------------

page 2 of 2

Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction

Hip - Capsular Repair (acetabular labral repair)

Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Harpoon® Suture Anchor are similar or identical to the predicate device or other previously cleared devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. except BioRaptor™ of Smith & Nephew.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2007

Biomet Sports Medicine, Inc. % Ms. Elizabeth Wray Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K071816

> Trade/Device Name: Harpoon® Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MBI Dated: June 29, 2007 Received: July 2, 2007

Dear Ms. Wray:

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 such additional controls. Existing major regulations affecting your devive can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA more 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Elizabeth Wray

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or 240-276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Harbque Buehng

M. J. N. M.

Mark N. Me Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:

Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair

Wrist - Scapholunate ligament reconstruction

Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair

Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement

Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction

Hip - Capsular Repair (acetabular labral repair)

Prescription Use _ YES AND/OR AND/OR CON Over-The-Counter Use NO (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Muchin
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number:** K071876

Page 1 of 1

4 - 1