RESOFIX BIOABSORBABLE EXPANSION BOLT

K043411 · Resofix, Inc. · HTN · Feb 17, 2005 · Orthopedic

Device Facts

• Record ID: K043411
• Device Name: RESOFIX BIOABSORBABLE EXPANSION BOLT
• Applicant: Resofix, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resofix® Bioabsorbable Expansion Bolt is a single-use, sterile implant that is intended for use in the interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

Device Story

Resofix Bioabsorbable Expansion Bolt is a single-use, sterile implant for ACL/PCL reconstruction; used for interference fixation of bone-tendon-bone and soft tissue grafts. Device consists of two-shell halves and a central expansion wedge forming an expanding dowel system. Insertion of wedge between shells causes expansion over full implant length; 2/3 round and 1/3 flat cross-section when expanded. Designed to maximize contact and maintain position during absorption. Used by surgeons in clinical settings. Biomechanical testing confirms performance equivalence to predicate. Benefits include secure graft fixation during ligament reconstruction.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: Poly-D,L-lactide (PDLLA, Resomer 208). Design: Two-shell bioabsorbable expansion bolt with central expansion wedge. Sizes: 8mm x 28mm and 10mm x 35mm. Expansion options: 2.2mm and 2.9mm. Sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Sulzer Orthopedics Ltd. Sysorb interference screws (K983592)
• Arthrex Bio-interference screw (K043411)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

Confidential

KO44411

Sponsor: Resofix. Inc. 5349 Red Leaf Court Oviedo. Florida 32765

## Resofix® Bioabsorbable Expansion Bolt Device:

- Classification Name: 21 CFR 888.3030 Fastener, Fixation, Biodegradable, Soft Tissue -Class II
Intended Use: The Resofix® Bioabsorbable Expansion Bolt is a single-use, sterile implant that is intended for use in the interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

Device Description: The Resofix product is a two-shell bioabsorbable expansion bolt, consisting of two shell halves, forming an expanding dowel system, and a central expansion wedge. Insertion of the expansion wedge between the dowel halves results in expansion over the full length of the implant. When expanded, 2/3 of the implant cross-section is round and 1/3 is flat. The surface of the implant is designed to maximize contact and maintain implant position, both immediately after being inserted, as well as during the absorption period. The Resofix® Bioabsorbable Expansion Bolt shell halves and expansion wedge are injection molded poly-D,L-lactide (PDLLA, Resomer 208), which is substantially equivalent to the material used by Sulzer Orthopedics Ltd. in its Sysorb interference screws, previously approved by the U.S. FDA (K983592). Included in the system are associated preparation and implantation instruments, which are exempt Class I instruments, per 21 CFR 888.4540, "Orthopaedic Manual Surgical Instruments". The Resofix PDLLA implants are available in two sizes (8mm x 28mm and 10mm x 35mm) and the 10mm units are available in two expansion options (2.2mm for bone-tendon-bone grafts and 2.9mm for semitendinosus gracilis grafts).

Potential Risks: Possible adverse effects include -

- Loosening, cracking or fracture of the bolt, which may be caused by insufficient . quality or quantity of base bone stock.
- Fracture of the femur or tibia caused by improper bolt placement. .
- Laceration of the graft material, which would most likely be caused by operative . instruments.
- Failure of the graft material to thrive following reconstruction. Although such a . situation is rare, it may lead to dissolution of the graft material and recurrent instability of the knee.
- Acute or late infection and low grade synovitis. .
- Cardiovascular disorders, including wound hematoma and thromboembolic disease. .
- Tissue reaction, including macrophage and foreign body reactions adjacent to the . bolt.

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**Confidential**
page 12

## Substantial Equivalence:

The Resofix® Bioabsorbable Expansion Bolt is similar in material and purpose to the Arthrex The I (coolix's Bloads on been previously cleared by the Food and Drug Dio-interference Oorcw which has been phone-lendon-bone and soft tissue grafts in ACL Administration for internetion, biomechanical testing confirms that differences in and TOL resofix® Bioabsorbable Expansion Bolt and predicate device, do not raise any new issues of safety or effectiveness.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of a caduceus, which is a traditional symbol of medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carl Knobloch Chief Operating Officer Resofix, Inc. 5349 Red Leaf Court Oviedo, Florida 32765

Re: K043411

Trade/Device Name: Resofix® Bioabsorbable Expansion Bolt Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: December 2, 2004 Received: December 13, 2004

FEB 1 7 2005

Dear Mr. Knobloch:

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, 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Carl Knobloch

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/industry/support/index.html

Sincerely yours,

Mark N. Wilkinson

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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page 1 of

Confidential

## INDICATIONS FOR USE

510(k) Number (if known): K043411

Device Name: Resofix® Bioabsorbable Expansion Bolt

Indications for Use: The Resofix® Bioabsorbable Expansion Bolt is a single-use, sterile implant that is intended for use in the interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CFR 801.109) X

Over-the-Counter Use (Optional Format 1-2-96)

Mark N. Mulker

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