SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM

K982155 · Influence, Inc. · MBI · Aug 31, 1998 · Orthopedic

Device Facts

• Record ID: K982155
• Device Name: SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
• Applicant: Influence, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Aug 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Short Shaft Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy).

Device Story

System consists of bone screws threaded with suture and an inserter tool; used for soft tissue-to-bone fixation in pelvic region. Device utilized during open surgical procedures by surgeons. Shortened inserter shaft provides improved maneuverability compared to predicate. Output is physical fixation of soft tissue to bone to treat stress urinary incontinence.

Clinical Evidence

Bench testing only.

Technological Characteristics

System comprises bone screws threaded with suture and an inserter. Design and materials are identical to the predicate device. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for soft tissue fixation to pelvic bones (pubic, sacral) in patients undergoing open surgical procedures, specifically bladder neck suspension or urethral sling procedures for female stress urinary incontinence (urethral hypermobility, intrinsic sphincter deficiency) or male stress urinary incontinence post-prostatectomy.

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

• Straight-In Bone Screw System (K972622)

Submission Summary (Full Text)

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## AUG 3 1 1998

## 510(k) Summary of Safety and Effectiveness Influence, Inc.'s Short Shaft Straight-In Bone Screw Fixation System 510(k) Number K982155

This 510(k) notification is submitted by Influence, Inc., 71 Stevenson Street, Suite 1120, San Francisco, California 94105. The contact person is Peter Bick, M.D., President and CEO.

This 510(k) notification describes a device intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. The Short Shaft Straight-In Bone Screw Fixation System is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy).

The Short Shaft Straight-In Bone Screw Fixation System is substantially equivalent to Influence, Inc.'s Straight-In Bone Screw System cleared under K972622. The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. The only difference is that the Inserter of the Short Straight-In device is shorter to serve the needs of users who prefer the maneuverability of a shorter device in open surgical procedures.

Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance.

Based on the information provided, the Short Shaft Straight-In Bone Screw Fixation System is substantially equivalent to the Straight-In device with respect to intended use, technological characteristics, and performance.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three lines forming the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 | 1998

Peter A. Bick, M.D. President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105

K982155 Re: Short Shaft Straight-In Trade Name: Bone Screw Fixation System Regulatory Class: II Product Codes: MBI and HWC Dated: June 18, 1998 Received: June 18, 1998

Dear Dr. Bick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Peter A. Bick, M.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General 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): | K982155 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Short Shaft Straight-In Bone Screw System |
| Indications for Use: | The Short Shaft Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy). |

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices

510(k) Number

X Prescription Use (Per 21 CFR 801.109) OR

Over the Counter Use_

ApcOeele
B

(Division Sign-Off) Division of General Re 510(k) Number

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