TRIABSORB COMPOSITE SCREW

K050468 · Advanced Biomaterials · HWC · Aug 31, 2005 · Orthopedic

Device Facts

• Record ID: K050468
• Device Name: TRIABSORB COMPOSITE SCREW
• Applicant: Advanced Biomaterials
• Product Code: HWC · Orthopedic
• Decision Date: Aug 31, 2005
• 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 The device to ourmalatour tapers and bone-tendon-bone patellar grafts during Interience inxation of Sont trough arthrough arthroscopy or arthroscopy or arthrotomy procedures.

Device Story

TriABSorb™ Composite Screw is a sterile, single-use, cannulated, tapered, smooth-threaded bone fixation fastener; used for interference fixation of soft tissue and bone-tendon-bone patellar grafts during ACL reconstruction. Device is implanted by surgeons during arthroscopic or arthrotomy procedures. Available in multiple lengths (20-45mm) and diameters (6-12mm) with left/right thread options to accommodate patient/graft morphology. Material composition includes PLLA, Tri-Calcium phosphate (TCP), and Hydroxyapatite (HA).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cannulated, tapered, smooth-threaded bone fixation fastener. Materials: PLLA, Tri-Calcium phosphate (TCP), Hydroxyapatite (HA). Dimensions: 20-45mm length, 6-12mm diameter. 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 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

• MITEK BIOCRYL INTERFERENCE SCREWS (K013572)
• OSTEO ACL SCREW MODEL (K032894)
• BIOLOK SCREW (K002070)
• BIOLOK SCREW, BIOSTEON SCREW (K003641)

Submission Summary (Full Text)

{0}------------------------------------------------

page 1 of 2

# AUG 3 1 2005

# 510(k) SUMMARY FOR ABS COMPOSITE TriABSorb™ Composite SCREW

ADVANCED BIOMATERIALS 510k #: K050468 Company: 265 Route de La Baronne, St. Jeannet 06640 France Adresse: [phone] Phone: [phone] Fax:

Mr Patrick Janin Contact:

Date of submission: February 18th 2005

Name of device:

TriABSorb™ Composite Screw

# Common or usual name:

Composite Interference Screw

# Classification:

Smooth or threaded bone fixation fastener: 888.3040

#### Predicate device:

| K013572 | MITEK BIOCRYL INTERFERENCE SCREWS (MITEK) |
|---------|----------------------------------------------|
| K032894 | OSTEO ACL SCREW MODEL (LINVATEC) |
| K002070 | BIOLOK SCREW (BIOCOMPOSITES) |
| K003641 | BIOLOK SCREW, BIOSTEON SCREW (BIOCOMPOSITES) |

#### Device description:

The TriABSorb™ composite screw is bio-absorbable sterile single use tapered and has a smooth threaded bone screw, which provides interference fixation of soft tissue nas a smooth througou bone 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 The device to ourmalatour tapers and bone-tendon-bone patellar grafts during Interience inxation of Sont trough arthrough arthroscopy or arthroscopy or arthrotomy procedures.

The ABS TriABSorb™ composite screw and predicate device have overall same intended use and design despite some minor modifications which do not affect the use, safety and effectiveness of the device.

{1}------------------------------------------------

page 2 of 2

The implants are made of similar biopolymer: PLLA (poly L-lactide acid), Tri-Calcium phosphate (TCP), Hydroxyapatite (HA).

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 polymers for the ABS TriABSorb™ composite screw has similar characteristics than the polymers use for the predicate devices.

The TriABSorb™ composite screw and the predicate devices 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 devices.

The principal difference is the mixture of the polymers and the insertion technique between the ABS screw and the predicate devices (the screwdriver driver hole).

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

Based on these similarities and equivalences our TriABSorb™ composite screw and the predicate devices 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-tendon-bone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2005

Mr. Patrick Janin ADVANCED BIOMATERIALS 265 Route de la Baronne St-Jeannet, 06640 France

Re: K050468

RoJo 106
Trade/Device Name: TriABSorb™ Composite Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 14, 2005 Received: July 1, 2005

Dear Mr. Janin:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o have 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 for use stated in the encreases) 76, 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). and Cosmetier for ( 10) has the device, subject to the general controls provisions of the Act. The r ou mayy are s 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 may or subject to been as begulations, 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.

{3}------------------------------------------------

Page 2 -- Mr. Patrick Janin

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maketing of substantial equivalence of your device to a legally premarket nothleation: "The PDA miams of basification 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 if you desire specific advice for your ac no no can and please note the regulation entitled, contact the Office of Complaned at (210) 276 of 807.97). You may obtain Misoraliums by releveloe to premainters in the Act from the Division of Small other general information on your responsibility of the mumber [phone] of the hard Manufacturers, International and Consamer Fiscibitition of and only industry/support/index.html

Sincerely yours,

signature

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510 K Number: K050468

Device name: TriABSorb™ Composite Screw

# INDICATIONS FOR USE:

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

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|----|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | No |

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K050468 |
|---------------|---------|
|---------------|---------|

..

:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)