BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM

K110039 · Biomet Sports Medicine · JDQ · May 3, 2011 · Orthopedic

Device Facts

• Record ID: K110039
• Device Name: BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
• Applicant: Biomet Sports Medicine
• Product Code: JDQ · Orthopedic
• Decision Date: May 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Device Story

System consists of implants (clips and ZipLoop™ constructs) and single-use instruments; used for stabilization and fixation of anterior chest wall fractures and sternal closure post-sternotomy/reconstruction. Surgeon inserts implants and applies tension to ZipLoop™ constructs to achieve desired bone alignment and stabilization. Used in surgical settings; intended for single use. Provides mechanical fixation to aid bone healing; benefits patient by maintaining sternal stability post-procedure.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, specifically cyclic fatigue testing comparing fixation strength to predicate devices.

Technological Characteristics

System includes clips and ZipLoop™ constructs with single-use insertion instruments. Materials and design are similar to predicate bone fixation cerclage devices. Mechanical fixation principle; single-use; non-sterile status not specified but implied single-use disposable.

Indications for Use

Indicated for patients requiring stabilization and fixation of anterior chest wall fractures, including sternal fixation post-sternotomy and sternal reconstructive procedures.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Ethi-Pack Surgical Stainless Steel Suture (K931271, K946173)
• Stony Brook Sterna-wire / Sterna-Band™ (K930015, K013059)
• SternaLock™ Rigid Sternal System / Lorenz Sternal Closure System (K011076, K063506)

Submission Summary (Full Text)

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K 110039 (pg. 1 of 2)

Image /page/0/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular border. Below the word "BIOMET" is the phrase "SPORTS MEDICINE" in a simple, sans-serif font. The logo is black and white.

MAY - 3 2011

# 510(k) Summarv

| Preparation Date: | April 13, 2011 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Sports Medicine |
| Contact Person: | Elizabeth Wray / Regulatory Project Manager<br>Victor Rodgers / Director of Quality, Clinical, & Regulatory<br>Affairs<br>[phone] |
| Proprietary Name: | Biomet Sports Medicine Sternal Closure System |
| Common Name: | Sternal Closure System |
| Classification Name: | Cerclage, Fixation (21CFR §888.3010) JDQ |

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| K931271 and K946173 | Ethi-Pack Surgical Stainless Steel Suture |
|---------------------|------------------------------------------------------------------|
| K930015 and K013059 | Stony Brook Sterna-wire / Sterna-Band™ |
| K011076 and K063506 | SternaLock™ Rigid Sternal System / Lorenz Sternal Closure System |

# Device Description:

The Biomet Sternal Fixation Devices System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. The Implants for this application include Clips and ZipLoop™ constructs packaged with single use instruments to assist in insertion and applying tension to close the ZipLoop™ construct to the desired size. The Biomet Sternal Fixation System Devices are single use.

# Intended Use:

The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

# Summary of Technologies:

The technological characteristics (materials, design, sizing and indications) of the Biomet Sports Medicine Sternal Closure System are similar or identical to the predicate devices or

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

Shipping Address:
16 East Bell Drive
Warsaw, IN 46582

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K110039 (pg. 2 of 2)

other previously cleared devices.

#### Non-Clinical Testing:

Non-clinical laboratory testing was performed to verify the fixation strength of the Biomet Sports Medicine Sternal Closure System in cyclic fatigue testing as compared to the predicate devices for specific indications for use. The efficacy of the Biomet Sports Medicine Sternal Closure System was compared to that of the Ethicon Surgical Stainless Steel Sutures. The test results indicate that the Biomet Sports Medicine Sternal Closure System provide equivalent cyclic fatigue 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 Biomet, Inc., except for Stema-Band™ which is a registered trademark of Peninsula Medical Products, LLC

DCC
5/4/11

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like design with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-00022

Biomet Sports Medicine % Ms. Elizabeth Wray Regulatory Project Manager 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46587

MAY - 3 2011

Re: K110039

Trade/Device Name: Biomet Sports Medicine Sternal Closure System
Regulation Number: 21 CFR 888 2020 Regulation Number: 21 CFR 888.3020 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: April 13, 2011 Received: April 14, 2011

Dear Ms. Wray: -

We have reviewed your Section 510(k) premarket notification of intent to market the device is a refered above and have determined the device is substantially equivalent to market the device
refered above and have determined the device is substantially equivalent for the for use and in the enclosure) to legally marketed predicate devices market in the terest.
Tor use stated in the enclosure) to legally marketed in interstate comments in election in tegally marketed predicate devices marketed in intersations
devices in to May 28, 1976, the enactment date of the Medical marketed in interstate
and C device in they 26, 1970, the enactment date of the Medical Incontributions of the State
devices hat have been reclassified in accordance with the provisions of the Federal Fo and Committere occh recure approval of a provisions of the Provisions of to
and Cometic Act (Act) that do not require approval of a premarket a of Drug. On Drug.
Comments of You may, the (rec) that do not require approval of a prematket approval province (reg.
You may, the the device, subject to the general controls provisions of the Act. The general controls market the Act include requirements for annual registsons of the Arthur (Pho
general controls provisions of the Act include requirements for annual registrat of the world provisions of the Act include requirements for annual registration is increases
devices, good manufacturing practice, labeling, and prohibitions against mistrand adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
four de subject to additional controls. Existing major regulations of may be subject to addition (see above) into either class II (Special Controls) or class III (PMA)
found in to additional controls. Existing major regulations affecting your found in the Code of Federal Regulations, Title 21, Parts 800 to 800 in (1 Miles in (1 Miles)
found in the Code of Federal Regulations, Title 21, Parts 800 to 800 m (1 min 1 the 2001 - 1 Cuclar Regulations, Title 21, Parts 800 to 898. In addition
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
the say Felect that France and TDA s Issuance of a substantial squivalence detemination dos not mean
that Floral statutes and regulations administered by other requirements of the Act of any with thias a decemmation that your devices with other manon about on the more and completed by and reguirements, including, but not limited to: register. You music of the Ace
CFR Part 807), labeling (21 CFR Part 801), but not limited to: registration and l CFR Part 807); abeling (21 CFR Part 801); medical device reporting (reporting (reporting (reporting (reporting (reporting (reporting (reporting (reporting of medical device and are events) (21 CFR 801); medical device reporting (good monded and disculg (2)
cortice related adverse events) (21 CFR 803); good manufacturing practice requirem forth in the quality systems (QS) regulation (2) CFR Part Corner of nactical (2010)
forth in the quality systems (QS) regulation (21 CFR Part 820); and ractive the electronic the has product radiation of stems (QS) regulation (21 CFR Part 820), and if applicable, the are a
product radiation control provisions (Sections 531-542 of the Act); 21 CFR

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# Page 2 - Ms. Elizabeth Wray

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
the Center for Brotin Box/AboutFDA/CentersOffices/CDRH/CDRHC/S and Poster openite advice tor your device on our labeling regulation (21 CFR Part 801), please
the Center for Devices and Radiological Health's (CDRH)Offices/CDRH/Offices/C the Continues and Radiological Health's (CDRHO) CDRHOffices/Cm (CDRHOff.)
not Center for Devices and Radiological Health's (CDRHO Compliance, Also, please 11300 100 Dorices and Raublogical Health's (CDRH's) Office of Compliance. Also, ph to
807.7). For questions by reference to premarket nocomarket nocompliance. Also, planet on and organation comments by reference to premarkets of million" (216). Por questions (216).
CFR Part 803), please go to

10 100 1000), prese go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.brundor the CDRH's Office - Surveillance and Biometrics/Devices/Safety/ReportaProblem/default.
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 the Act from the
(80) 638-2041 or [phone] or at its International and Consumer Assistance at its [phone] or [phone] or at its Internet address 1964) 1982 2017 of [phone] or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html.

.ResourceCstor.You/industry/default.htm.

Sincerely yours.

Aliz B. Rita
for

Mark N. Melkerso 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 | 0039

Device Name: Biomet Sports Medicine Sternal Closure System

Indications For Use:

The Biomet Sports Medicine Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Prescription Use_ × (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)

Asr M. Melkersson

Page 1 of 1

(Division Sigh Off) (Division of Surgical, Orthopedic, Division of Surges

Number K110039

510(k) Number .