PLLA CANNULATED INTERFERENCE SCREW

K032830 · Advanced Biomaterials · HWC · Dec 14, 2004 · Orthopedic

Device Facts

• Record ID: K032830
• Device Name: PLLA CANNULATED INTERFERENCE SCREW
• Applicant: Advanced Biomaterials
• Product Code: HWC · Orthopedic
• Decision Date: Dec 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is cannulated, tapered with a smooth threaded design, which provides interference fixation of soft-tissue grafts and bonetendon-bone patellar grafts during anterior cruciate ligament repair and reconstruction through arthroscopy or arthrotomy procedures.

Device Story

PLLA cannulated interference screw; bioabsorbable, sterile, single-use, tapered, smooth-threaded bone fixation fastener. Used during ACL repair/reconstruction to provide interference fixation of soft-tissue or bone-tendon-bone patellar grafts. Implanted by surgeons via arthroscopy or arthrotomy. Available in multiple lengths (20-45mm) and diameters (6-12mm) with left/right thread options to match patient/graft morphology. Provides mechanical fixation of graft within bone tunnel; material (poly-L-lactic acid) resorbs over time. Benefits include secure graft fixation during healing process.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and intended use similarities to predicate devices, supported by in vitro and in vivo testing of the PLLA polymer.

Technological Characteristics

Material: Poly-L-lactic acid (PLLA) biopolymer. Design: Cannulated, tapered, smooth-threaded screw. Dimensions: 20-45mm length, 6-12mm diameter. Energy source: None (mechanical fixation). Sterilization: Sterile, single-use.

Indications for Use

Indicated for interference fixation of soft tissue grafts and bone-tendon-bone patellar grafts during Anterior Cruciate Ligament (ACL) repair and reconstruction via arthroscopy or arthrotomy.

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

• FMS Cannulated bioabsorbable interference screw (K013685)
• Arthrex Bio-interference screw (K971358)

Submission Summary (Full Text)

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## 510(k) SUMMARY FOR THE PLLA CANNULATED INTERFERENCE SCREW

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510k #: K032438

## DEC 1 4 2004

ADVANCED BIOMATERIALS Company: 265 Route de La Baronne, St. Jeannet 06640 France Adresse: Phone: [phone] [phone] Fax:

Mr Patrick Janin Contact:

September 10th 2003 Date of submission:

Name of device:

PLLA cannulated interference screw

#### Common or usual name:

Bioabsorbable interference screw

Classification:

Smooth or threaded bone fixation fastener: 888.3040

#### Predicate device:

FMS Cannulated bioabsorbable interference screw (K013685) Arthrex Bio-interference screw (K971358)

#### Device description:

The PLLA cannulated interference screw is bio-absorbable sterile single use tapered and has a smooth threaded bone screw, which provides interference fixation of soft tissue grafts and bone-tendonbone patellar grafts during Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

#### Intended use:

The device is cannulated, tapered with a smooth threaded design, which provides interference fixation of soft-tissue grafts and bonetendon-bone patellar grafts during anterior cruciate ligament repair and reconstruction through arthroscopy or arthrotomy procedures.

The ABS interference screw and predicate device have overall same intended use and design despite some minor modifications which does not affect the reconstruction process.

Both implants are made of similar biopolymer (polylactic acid)

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### 510(k) SUMMARY FOR THE PLLA CANNULATED INTERFERENCE SCREW

The screw comes in multiple lengths (20mm to 45mm), multiple diameters (6mm to 12mm) in each length and left and right thread design, resulting in a set of screws adapted to the morphology of the graft and the patient.

#### Substantial equivalence:

The polymer for the ABS interference screw has similar characteristics than the polymer use for the predicate device (both are poly L.D lactic acid) and is currently use in many devices which have received FDA marketing clearance, and has undergone many in vitro and in vivo testing.

The PLLA cannulated interference screw and the predicate device have the same overall design. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device.

The principal difference in the insertion technique between the ABS PLLA screw and the Arthrex bio-interference screw is the method of attaching the screwdriver to the screw during insertion.

The ABS interference screw is equivalent in material, design and intended use as the predicate device.

Based on these similarities and equivalences we believe our PLLA cannulated interference screw and the Arthrex bio-interference screw K971538 are substantially equivalent for the interference fixation of soft tissue and Bone Tendon Bone graft in the ACL reconstruction through arthroscopy or arthrotomy.

#### Indications for use:

To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2004

Mr. Patrick Janin President Advanced Biomaterials 265 Route de la Baronne F-06640 St. Jeannet France

Re: K032830

Trade/Device Name: PLLA cannulated interference screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: October 19, 2004 Received: October 21, 2004

Dear Mr. Janin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your se determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreativent of the enactment date of the Medical Device Amendments, or to connered prof to they 2011-12-12 accordance with the provisions of the Federal Food, Drug, de nees that have been 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 - Mr. Patrick Janin

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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,
Mark Walker

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Ko Z > { } &

Device name: PLLA cannulated interference screw

Indications For Use:

To provide interference fixation of soft tissue graft and bone-tendonbone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

Prescription Use y 22 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

e-Counter Use
(21 CFR 807 Subpart C) No

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Milliken
Division Sign-Off

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K032850