SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)

K090241 · Synthes (Usa) · HSB · Jun 17, 2009 · Orthopedic

Device Facts

• Record ID: K090241
• Device Name: SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Jun 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Angular Stable Locking System (ASLS), when used with Synthes Cannulated Titanium Intramedullary Nails, is intended to aid in the alignment and stabilization of tibial, humeral, femoral, and ankle fractures.

Device Story

Synthes Angular Stable Locking System (ASLS) serves as an alternative interlocking mechanism for Synthes Cannulated Titanium Intramedullary Nails. Device consists of a titanium screw combined with a 70:30 Poly (L/DL-Lactide) sleeve. Used by surgeons in clinical settings to provide angular stability during the fixation of long bone fractures (tibial, humeral, femoral) and ankle fractures. The system aids in fracture alignment and stabilization; it is implanted during orthopedic surgical procedures.

Clinical Evidence

bench testing only

Technological Characteristics

Titanium screw with 70:30 Poly (L/DL-Lactide) sleeve. Diameters: 4.0 mm - 6.0 mm. Lengths: 23 mm - 125 mm. Mechanical fixation device.

Indications for Use

Indicated for patients requiring alignment and stabilization of tibial, humeral, femoral, and ankle fractures using Synthes Cannulated Titanium Intramedullary Nails.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Synthes 3.9 mm Ti Locking Bolts
• Synthes 4.9 mm Ti Locking Bolts
• Synthes 6.0 mm Locking Screws

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A small registered trademark symbol is located to the right of the word.

Revised 510(k) Summary Page of -Sponsor: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 [phone] JUN 1 7 2009 Contact: Sheri L. Musgnung Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 [phone] FAX [phone] .. .. . . . . . Device Name: Synthes Angular Stable Locking System (ASLS) Classification: Class II, §888.3020 - Intramedullary fixation rod Predicate Device: Synthes 3.9 mm Ti Locking Bolts Synthes 4.9 mm Ti Locking Bolts Synthes 6.0 mm Locking Screws Synthes Angular Stable Locking System (ASLS) is designed as an Device Description: alternative device for the interlocking of Synthes Cannulated Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a 70:30 Poly (L/DL-Lactide) sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 23 mm - 125 mm. Intended Use: The Synthes Angular Stable Locking System (ASLS), when used with Synthes Cannulated Titanium Intramedullary Nails, is intended to aid in the alignment and stabilization of tibial, humeral, femoral, and ankle fractures. Substantial Information presented supports substantial equivalence, Equivalence:

K090241

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 7 2009

Synthes (USA) % Ms. Sheri L. Musgnung Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K090241

Trade/Device Name: Synthes Angular Stable Locking System (ASLS) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: June 10, 2009 Received: June 11, 2009

Dear Ms. Musgnung:

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

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

Page 2-Ms. Sheri L. Musgnung

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/cdrh/indr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrle

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

Enclosure

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

Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A registered trademark symbol is located to the right of the word.

Revised Indications for Use

510(k) Number (if known):

K090241

Device Name:

Synthes Angular Stable Locking System (ASLS)

Indications for Use:

The Synthes Angular Stable Locking System (ASLS), when used with Synthes Cannulated Titanium Intramedullary Nails, is intended to aid in the alignment and stabilization of tibial, humeral, femoral, and ankle fractures.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (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)

Barbara Bucheo tx man

Division Sig 1-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090241