SIJF CANNULATED SCREW SYSTEM

K051296 · Depuy Spine, Inc. · OUR · Aug 26, 2005 · Orthopedic

Device Facts

• Record ID: K051296
• Device Name: SIJF CANNULATED SCREW SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Aug 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIJF Cannulated Screw is intended for fracture fixation of long bones and of the pelvis for such conditions as degenerative sacroiliitis, trauma (fracture and/or dislocation) or tumor, iatrogenic instability and Osteitis Condensans Ilii. The system is not intended for spinal use.

Device Story

The SIJF Cannulated Screw System consists of cannulated titanium screws used for orthopedic fracture fixation. The device is implanted by a surgeon in a clinical setting to stabilize long bones or the pelvis. The screws provide mechanical fixation to address conditions such as trauma, tumors, or instability. The system includes manual surgical instruments for implantation. The device is not intended for spinal applications.

Clinical Evidence

No clinical data; performance data were submitted to characterize the SIJF Cannulated Screw components.

Technological Characteristics

Materials: ASTM F-136 implant grade titanium alloy. Design: Cannulated screws, 6.5mm and 8.0mm diameters, 40mm to 50mm lengths (2mm increments). Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for fracture fixation of long bones and pelvis in patients with degenerative sacroiliitis, trauma (fracture/dislocation), tumor, or iatrogenic instability, and Osteitis Condensans Ilii. Not for spinal use.

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

• Stryker Asnis III Cannulated Screws (K000080 and K024060)
• ACE Medical Cannulated Screws (K903810)

Submission Summary (Full Text)

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## K051296 IX. 510(k) Summary

- DePuy Spine, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780
Mary E. Gray CONTACT PERSON: Telephone [phone] Fax [phone]

- August 12, 2005 DATE PREPARED:
CLASSIFICATION NAME: Smooth or threaded metallic bone fixation fastener

- SIJF Cannulated Screw System PROPRIETARY NAME:
- Stryker Asnis III Cannulated Screws (K000080 and PREDICATE DEVICES: K024060) ACE Medical Cannulated Screws (K903810)

SIJF Cannulated Screws consists of cannulated DEVICE DESCRIPTION: screws available in titanium in two diameters of 6.5mm and 8.0mm with lengths ranging from 40mm to 50mm, in 2mm increments.

> The SIJF System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

- The SIJF Cannulated Screw is intended for fracture INTENDED USE: fixation of long bones and of the pelvis for such conditions as degenerative sacroiliitis, trauma (fracture and/or dislocation) or tumor, iatrogenic instability and Osteitis Condensans IIii. The system is not intended for spinal use.
- Manufactured from ASTM F-136 implant grade titanium MATERIALS: alloy.

## PERFORMANCE DATA:

Performance data were submitted to characterize the SIJF Cannulated Screw components.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

APR - 7 2011

DePuy Spine, Inc. % Ms. Mary E. Gray, RAC Sr. Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K051296

Trade/Device Name: SIJF Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: August 12, 2005 Received: August 15, 2005

Dear Ms. Gray:

This letter corrects our substantially equivalent letter of August 26, 2005.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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Page 2 - Ms. Mary E. Gray, RAC

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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Aky B. R. h
for

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 111.

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

SIJF Cannulated Screw System Device Name:

Indications For Use:

The SIJF Cannulated Screw is intended for fracture fixation of long bones and of
the SIJF Cannulation in the secondition tractive assessilities, trauma (fracture and/or The SIJF Cannulated Schew is intended in Tracterilitiis, trauma (fracture and/or
the pelvis for such conditions as degenerative sacrollilities, traume and/or the pelvis for such conditions as acgenerative cash and Osteitis Condensans Illi. The system is not intended for spinal use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) |

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | K501296 |
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