BIOABSORBABLE INTERFERENCE SCREWS

K984320 · Smith & Nephew, Inc. · HWC · Jan 28, 1999 · Orthopedic

Device Facts

• Record ID: K984320
• Device Name: BIOABSORBABLE INTERFERENCE SCREWS
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bioabsorbable Interference screw is used for fixation of bone-tendonbone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

Device Story

Bioabsorbable Interference Screw; orthopedic fixation device; used in ACL/PCL reconstruction surgery. Input: surgical graft and bone site. Operation: mechanical screw fixation of bone-tendon-bone or soft-tissue grafts to bone. Output: physical graft stabilization. Used in OR by orthopedic surgeons. Benefits: provides secure graft fixation during ligament reconstruction; bioabsorbable material eliminates need for secondary removal surgery.

Clinical Evidence

Bench testing only. Comparative performance testing conducted against the predicate Arthrex PLLA Bio-Screw.

Technological Characteristics

Material: Polylactic acid (PLA). Dimensions: 7-9 mm diameter, 20-30 mm length. Sterilization: Ethylene Oxide. Single-use. Mechanical fixation device.

Indications for Use

Indicated for fixation of bone-tendon-bone or soft-tissue grafts during ACL/PCL reconstruction. Single use only.

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

• Arthrex Bio-Interference Screw (K945303)

Submission Summary (Full Text)

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JAN 28 1999

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is : K984320

This summary was prepared on December 1, 1998

#### A. Submitter

Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048

#### Company Contact B.

Demetrios Tsakonas Clinical/Regulatory Specialist

#### C. Device Name

| Trade Name: | Bioabsorbable Interference Screw |
|----------------------|------------------------------------|
| Common Name: | Screw, Fixation, Bone, Orthopedics |
| Classification Name: | Screw: 87HWC |

#### D. Predicate/Legally Marketed Devices

Arthrex Bio-Interference Screw (510K # K 945303) Arthrex, Inc. 3050 North Horseshoe Drive Naples, Florida

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#### E. Device Description

The Bioabsorbable Interference Screw is a screw that has a range of diameters from 7 to 9 mm and a length that ranges from 20 mm to 30 mm. The Arthrex PLLA Bio-Screw is provided in a range of diameters from 7 to 9 mm and one length, 23 mm. The material of construction for both screws is polylactic acid.

#### F. Performance

The Bioabsorbable Interference screw has been tested against the Arthrex PLLA Bio-Screw. Both screws had results which are recorded in the test results located in attachment one.

### G. Intended Use

Both screws have similar intended uses. The screws are used to fixate grafts to bone during anterior cruciate ligament reconstruction surgery. The Bioabsorbable is expanding that indication to soft-tissue.

#### H. Substantial Equivalence

The Bioabsorbable Interference Screw and the Arthrex PLLA have similar designs. Both are used in fixating grafts to bone. The material for both screws are the same and the screws have similar dimensions.

Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices requlations.

A summary comparison of the characteristics of the Bioabsorbable Interference Screw and the substantially equivalent devices is presented in the table below.

| | Current Product | Substantially Equivalent Product |
|----------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Attribute<br>↓ | Bioabsorbable Interference Screw | Arthrex PLLA Bio-Screw |
| Indication | Bone-Tendon-Bone or Soft Tissue Graft<br>Fixation for ACL/PCL<br>Reconstruction | Bone-Tendon-Bone or Soft Tissue Graft<br>Fixation for ACL Reconstruction |
| Dimensions | Diameter: 7 - 9 mm | Diameter: 7 - 9 mm |
| | Length: 20 - 30 mm | Length: 23 mm |
| Material | PLA | PLA |
| Sterilization | Ethylene Oxide | NA |
| Labeling | Sterile, Single Use Only | NA |
| Applicant | Demetrios Jackson | |
| Date | 12/2/98 | |

Applicant

Date 12/2/98

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

Mr. Demetrios Tsakonas Clinical/Requlatory Specialist Smith & Nephew Endoscopy 130 Forbes Boulevard Mansfield, Massachusetts 02048

K984320 Re : Bioabsorbable Interference Screw Trade Name: Requlatory Class: II Product Codes: HWC and MAI Dated: December 2, 1998 Received: December 3, 1998

## Dear Mr. Tsakonas:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 - Mr. Demetrios Tsakonas

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 requlation (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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510 (k) Number (If Known):

Device Name: Bioabsorbable Interference Screw

Intended Use: Bioabsorbable Interference screw is used for fixation of bone-tendonbone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

Indications:

- 1. The Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or softtissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
- 2. The screw is indicated for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Picedo

Prescription Use
(Per 21 CFR 801.109)

or Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________