SLEEVE WITH ZIPLOOP FIXATION DEVICES

K101063 · Biomet Sports Medicine · MBI · Jun 23, 2010 · Orthopedic

Device Facts

• Record ID: K101063
• Device Name: SLEEVE WITH ZIPLOOP FIXATION DEVICES
• Applicant: Biomet Sports Medicine
• Product Code: MBI · Orthopedic
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sleeve with ZipLoop™ Fixation Devices are intended for 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 reconstruction, Tendon transfers in phalanx, Volar plate reconstruction Hip Acetabular labral repair

Device Story

Sleeve with ZipLoop™ Fixation Device; three-component assembly consisting of two sleeves and adjustable ZipLoop™ construct made of fiber material. Used by surgeons in orthopedic procedures to aid soft tissue-to-bone reattachment. Principle of operation: surgeon pulls ZipLoop™ construct tight, causing sleeves to lock against bone, thereby fixating soft tissue. Used in clinical settings (OR). Output is mechanical fixation of soft tissue. Benefits patient by providing secure reattachment during surgical repair.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing (pullout tests) comparing fixation strength to predicate devices.

Technological Characteristics

Three-component assembly: two sleeves and adjustable fiber-based ZipLoop™ construct. Mechanical fixation principle. No energy source. Dimensions and materials are similar to predicate devices. Non-implantable software/electronics not applicable.

Indications for Use

Indicated for patients requiring soft tissue-to-bone reattachment in the shoulder, foot, ankle, elbow, knee, hand, wrist, and hip. Specific procedures include Bankart, SLAP, rotator cuff, biceps tenodesis, hallux valgus, Achilles tendon, ligament reconstructions, and various tendon/capsular repairs.

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

• Sleeve and Button Soft Tissue Devices (K071704)
• Multitak SS Suture System™ (K973015)
• BioRaptor™ Suture Anchors (K053344)

Submission Summary (Full Text)

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K101063 (1/2)

Image /page/0/Picture/1 description: The image contains the words "SPORTS MEDICINE". The word "SPORTS" is on the left side of the image, and the word "MEDICINE" is on the right side of the image. The words are in all capital letters and are in a sans-serif font. The words are black and the background is white.

'JUN 2 8 2010

# 510(k) Summary

| Preparation Date: | June 17, 2010 |
|-------------------|---------------|
|-------------------|---------------|

Applicant/Sponsor: Biomet Sports Medicine

Contact Person: Robert Friddle Regulatory Affairs Specialist

Proprietary Name: Sleeve with ZipLoop™ Fixation Devices

- Common Name: Soft tissue fixation device
### Classification Name:

- MBI (888.3040): Fastener, fixation, nondegradable, soft tissue ●
- JDR (888.3030): Staple, Fixation, Bone

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| K071704 | Sleeve and Button Soft Tissue Devices |
|---------|---------------------------------------|
| K973015 | Multitak SS Suture System™ |
| K053344 | BioRaptor™ Suture Anchors |

### Device Description:

The Sleeve with ZipLoop™ Fixation Devices are a three component assembly consisting of two sleeves and a ZipLoop™ construct. The ZipLoop™ construct is an adjustable loop created with a single piece of fiber material. When the ZipLoop™ is pulled tight, the sleeve locks against the bone fixating the soft tissue. The Sleeve with ZipLoop™ Fixation Devices provide the surgeon with a means to aid in the management of soft tissue to bone reattachment procedures.

### Intended Use/Indications for Use:

The Sleeve with ZipLoop™ Fixation Devices are intended for 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

Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: [phone] www.biomei.com

Shipping Address: 56 East Bell Drive Warsaw. IN 45582

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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 reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

# Hip

Acetabular labral repair

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the Sleeve with ZipLoop™ Fixation Devices are similar or identical to the predicate devices or other previously cleared devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to verify the fixation strength of the Sleeve with ZipLoop™ Fixation Devices in pullout tests as compared to the predicate devices for specific indications for use. The test results indicate that the Sleeve with ZipLoop™ Fixation Devices provide equivalent pullout strength to the predicate devices and would be functional within their intended use.

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

All trademarks are the property of Biomer, Inc. except Multich is a trademark of Bonutt Research and BioRaptor™ which is a trademark of Smith & Nephew.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three lines representing its wings and a circular border around the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written along the circular border. The text is written in all capital letters.

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

Biomet Sports Medicine % Mr. Robert Friddle 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

JUN 2 3 2010

Re: K101063

Trade/Device Name: Sleeve with ZipLoop™ Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: April 15, 2010 Received: April 16, 2010

Dear Mr. Friddle:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Mr. Robert Friddle

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/ReportaProblem/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,

Mark A. Millan

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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# Indications for Use

510(k) Number (if known): K|0|063

Device Name: Sleeve with ZipLoop™ Fixation Devices

Indications for Use:

The Sleeve with ZipLoop™ Fixation Devices are intended for 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 reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

### Hip

.

تقييم سي

Acetabular labral repair

Prescription Use X (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)

Smitu for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K10163

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