SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)

K061910 · Synthes (Usa) · HSB · Sep 21, 2006 · Orthopedic

Device Facts

• Record ID: K061910
• Device Name: SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Angular Stable Locking System (ASLS) is indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking.

Device Story

Synthes Angular Stable Locking System (ASLS) serves as an alternative interlocking mechanism for Synthes Titanium Intramedullary Nails. Device consists of a titanium screw with a premounted PEEK sleeve. Used by surgeons in clinical settings to provide angular and axial stability to intramedullary nail constructs. The PEEK sleeve expands upon insertion to lock the screw within the nail, enhancing construct stability compared to standard locking bolts. Benefits include improved mechanical stability for fracture fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium screw with premounted PEEK sleeve. Diameters: 4.0 mm - 6.0 mm. Lengths: 26 mm - 125 mm. Mechanical fixation device for use with intramedullary nails.

Indications for Use

Indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking in patients requiring intramedullary fixation.

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)

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| 510(k) Summary | Page 1 of 1 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone]<br>SEP 2 1 2006 |
| 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<br>Synthes 4.9 mm Ti Locking Bolts<br>Synthes 6.0 mm Locking Screws |
| Device Description: | Synthes Angular Stable Locking System (ASLS) is designed as an<br>alternative device for interlocking Synthes Titanium Intramedullary<br>Nails. The ASLS consists of a titanium screw with a premounted<br>peek sleeve and is available in diameters ranging between 4.0 mm<br>- 6.0 mm and overall lengths ranging between 26 mm - 125 mm. |
| Intended Use: | Synthes Angular Stable Locking System (ASLS) is indicated for<br>use with Synthes Titanium Intramedullary Nails to achieve angular<br>and axial stable locking. |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 2 1 2006

Re: K061910

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 5, 2006 Received: July 6, 2006

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 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 - Ms. Sheri L. Musgnung

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" (21CFR Part 807.97). 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,

Mark A. Millerson

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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| 2.0 | Indications for Use |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | |
| Device Name: | Synthes Angular Stable Locking System (ASLS) |
| Indications for Use: | Synthes Angular Stable Locking System (ASLS) is indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking. |
| Prescription Use<br>(Per 21 CFR 801.109) | X |
| | AND/OR |
| | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mullen

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

000004