SLEEVE AND BUTTON SOFT TISSUE DEVICES

K071704 · Biomet Sports Medicine, Inc. · MBI · Sep 17, 2007 · Orthopedic

Device Facts

• Record ID: K071704
• Device Name: SLEEVE AND BUTTON SOFT TISSUE DEVICES
• Applicant: Biomet Sports Medicine, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Sep 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications: Shoulder: Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis. Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair. Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment. Knee: Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure. Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction. Hip: Acetabular labral repair. In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following: Knee: ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction.

Device Story

Sleeve and Button Soft Tissue Devices consist of ZipLoop™ technology, a button or coreless sleeve, and a passing suture. ZipLoop™ is constructed from UHMWPE or polyester. Device functions by passing through sleeve or button to create fixation that bunches or locks against bone upon deployment. Used in surgical settings by orthopedic surgeons for soft tissue-to-bone fixation. Output is a mechanical fixation construct. Benefits include secure attachment of soft tissue to bone to facilitate healing in various orthopedic repairs.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical laboratory testing.

Technological Characteristics

Constructed from ultra high molecular weight polyethylene (UHMWPE), polypropylene, or polyester braided fibers. Components include a ZipLoop™, button, or coreless sleeve. Mechanical fixation principle via bunching/locking against bone. Sizing varies by material and application (e.g., #2-0 or greater loops).

Indications for Use

Indicated for soft tissue to bone fixation in patients requiring repair or reconstruction of ligaments and tendons in the shoulder, foot, ankle, elbow, knee, hand, wrist, and hip. Specific applications include ACL/PCL repair, rotator cuff repair, and various ligamentous 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

• Multitak SS Suture System™ (K973015)
• BioRaptor™ (K053344)
• Cruciate Ligament Button (PolySuture Button) (K813581)

Submission Summary (Full Text)

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K07'704

Image /page/0/Picture/1 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a stylized font. The letters are bold and blocky, with the "T" extending to the top and bottom of the other letters. The word "INC" is written vertically to the right of the "T".

# 510(k) Summary

28 2 2000

Preparation Date: June 20, 2007

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

Contact Person: Elizabeth Wray

Proprietary Name: Sleeve and Button Soft Tissue Devices

Common Name: Soft tissue fixation device

#### Classification Name:

- MAI (888.3030): Fastener, fixation, biodegradable, soft tissue .
- MBI (888.3040): Fastener, fixation, nondegradable, soft tissue #

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

| Device | Multitak SS Suture<br>System™ | BioRaptor™ | Cruciate Ligament<br>Button (PolySuture<br>Button) |
|---------------|-------------------------------|----------------|----------------------------------------------------|
| Manufacturer | Bonutti Research | Smith & Nephew | Biomet Sports Medicine* |
| 510(k) Number | K973015 | K053344 | K813581 |

Device Description: The Sleeve and Button Soft Tissue Devices are comprised of a ZipLoop™ , a Button or a coreless Sleeve structure, and a passing suture. A ZipLoop™ is constructed from ultra high molecular weight polyethylene (UHMWPE) or polyester. It is passed through the Sleeve or Button, thus creating a soft tissue fixation device that bunches or locks against the bone when deployed.

#### Indications for Use/Intended Use:

The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:

#### Shoulder

Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis

#### Foot and Ankle

Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

#### Elbow

Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

Image /page/0/Picture/23 description: The image is a low-resolution picture that is mostly white. There are some black spots scattered throughout the image. The black spots are concentrated in the upper left and upper right corners of the image. The black spots are more sparse in the center of the image.

5-1

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### Knee

Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

### Hand and Wrist

Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

### Hip

Acetabular labral repair

In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:

#### Knee

ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction

#### Table 1

| | | Sleeve Size | |
|--------------------------|-----------|--------------------------|-----------|
| UHMWPE/<br>Polypropylene | Polyester | UHMWPE/<br>Polypropylene | Polyester |
| #2-0 or > | -- | #2 or > | -- |
| #2-0 or > | -- | -- | #0 or > |
| -- | #2 or > | -- | #5 or > |

Example: The following sleeve device combination may be used for ACL/PCL indications: #2-0 UHMWPE/Polypropylene Loop + #2 UHMWPE/Polypropylene Sleeve

Note: The loop and sleeve sizes denote the diameter of the original UHMWPE/Polypropylene or polyester braided fiber.

Summary of Technologies: The technological characteristics (materials, design, sizing, and indications) of the Sleeve and Button Soft Tissue Devices 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 Multitak SS Suture System™ of BloRaptor™ of Smith & Nephew.

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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 representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Elizabeth Wray Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

SEP 1 7 2007

Re: K071704

> Trade/Device Name: Biomet Sleeve and Button Soft Tissue Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, JDR Dated: June 20, 2007 Received: June 21, 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 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); 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.

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# Page 2 -

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 [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Sincerely yours,

Barbara Buettner

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

Enclosure

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# Indications for Use

510(k) Number (if known):__K ●フレフ●4

Sleeve and Button Soft Tissue Devices ________________________________________________________________________________________________________________________________________ Device Name: ________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Sleeve and Button Soft Tissue Devices utilizing ZipLoop™ Technology are intended for soft tissue to bone fixation for the following indications:

### Shoulder

Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis

# Foot and Ankle

Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

# Elbow

Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment

# Knee

Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure

### Hand and Wrist

Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

# Hip

Acetabular labral repair

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Durkare buen

Restorative. and Neurological Devices

510(k) Number K071704 4-1

Page 1 of 2

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In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following:

# Knee

ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction

# Table 1

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Loop Size | | Sleeve Size | |
|--------------------------|-----------|--------------------------|-----------|
| UHMWPE/<br>Polypropylene | Polyester | UHMWPE/<br>Polypropylene | Polyester |
| #2-0 or > | -- | #2 or > | -- |
| #2-0 or > | -- | -- | #0 or > |
| -- | #2 or > | -- | #5 or > |

The following sleeve device combination may be used for ACL/PCL indications: Example: #2-0 UHMWPE/Polypropylene Loop + #2 UHMWPE/Polypropylene Sleeve

The loop and sleeve sizes denote the diameter of the original Note: UHMWPE/Polypropylene or polyester braided fiber.

| Prescription Use | YES |
|-----------------------------|-----|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | NO |
|------------------------|----|
| (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)