SURFIX KNEE OSTEOTOMY SYSTEM

K041601 · Surfix Technologies · HRS · Aug 27, 2004 · Orthopedic

Device Facts

• Record ID: K041601
• Device Name: SURFIX KNEE OSTEOTOMY SYSTEM
• Applicant: Surfix Technologies
• Product Code: HRS · Orthopedic
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SURFIX® Knee Osteotomy System is intended for open and closed wedge osteotomies of the proximal tibia and the distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis.

Device Story

SURFIX Knee Osteotomy System comprises stainless steel plates and titanium alloy or stainless steel screws/lock screws. System provides locking mechanism between threaded plate sockets and screws, creating single implant/screw unit fixed into bone. Used by surgeons for proximal tibia and distal femoral osteotomies to treat bone/joint deformities and malalignment (e.g., osteoarthritis). Device stabilizes bone segments during healing; benefits patient by restoring alignment and reducing joint pain.

Clinical Evidence

Bench testing only. Dynamic fatigue strength testing and static bending/twisting strength tests performed to evaluate mechanical resistance and behavior compared to common bone plates.

Technological Characteristics

System consists of stainless steel plates and titanium alloy or stainless steel screws (cancellous 6.5mm, cortical 4.5mm). Features locking mechanism between threaded plate sockets and screws. Mechanical fixation via single implant/screw unit. No software or electronic components.

Indications for Use

Indicated for knee osteotomies including high tibial osteotomy and femoral osteotomy in cases of osteoarthritis of the medial tibiofemoral compartment with genu varum and lateral gonarthrosis on genu valgum. Specific applications include fixation of opening/closing wedge high tibial osteotomy, fixation of medial/lateral tibial plateau fractures, and distal femoral varus osteotomy.

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

• Synthes TomoFix™ Osteotomy System (K023941)
• Arthrex Modified Osteotomy System (K014155)

Submission Summary (Full Text)

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K041601

1 OF 3

# AUG 2 7 2004

### SUMMARY OF SAFETY AND EFFECTIVENESS 3.

#### SPONSOR IDENTIFICATION A.

SURFIX TECHNOLOGIES SA Parc Tertiaire des Grésillières 7 avenue Jules Verne 44 230 SAINT SEBASTIEN SUR LOIRE - FRANCE

Tel.: [phone] Fax: [phone]

#### ESTABLISHMENT REGISTRATION NUMBER B.

Pending

#### OFFICIAL CONTACT PERSON C.

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854

Tel .: [phone] Fax: [phone] estrin @yourFDAconsultant.com

## DATE OF PREPARATION OF THIS SUMMARY: March 24, 2004

#### D. PROPRIETARY (TRADE) NAME

SURFIX® Knee Osteotomy System

#### E. COMMON NAME

SURFIX® pre moulded plate for opening wedge high tibial osteotomy right and left sides

SURFIX® pre moulded plate for closing wedge high tibial osteotomy right and left sides

SURFIX® reinforced and pre moulded plate for closing wedge high tibial osteotomy right and left sides

SURFIX® distal femoral varus osteotomy plate

#### DEVICE CLASSIFICATION NAME F.

PLATE, FIXATION, BONE (21 CFR PAR. 888.3030)

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K041601
20F3

#### PROPOSED REGULATORY CLASS G.

Class II

#### DEVICE PRODUCT CODE H.

87 HRS

#### PANEL CODE l.

87 OR Orthopedic

#### DEVICE DESCRIPTION J.

The SURFIX® Knee Osteotomy System consists of seven different Stainless Steel plates with a locking system between the threaded sockets of the plates and the lock screws. There are six plates for the proximal tibia and one plate for the distal femur. Their fixation is provided by Titanium alloy or Stainless Steel SURFIX® screws and lock screws available in two versions: cancellous bone screws diameter 6.5 mm and cortical bone screws diameter 4.5 mm. The SURFIX® system fixation creates a single implant/screw unit fixed into the bone thanks the lock screw.

| INTENDED USE: | The SURFIX® Knee Osteotomy System is intended<br>for open and closed wedge osteotomies of the proximal<br>tibia and the distal femur, treatment of bone and joint<br>deformities, and malalignment caused by injury or<br>disease such as osteoarthritis. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR<br>USE: | The SURFIX® Knee Osteotomy System is indicated<br>for knee osteotomies including high tibial osteotomy<br>and femoral osteotomy in the cases of osteoarthritis of<br>the medial tibiofemoral compartment with genu varum<br>and lateral gonarthrosis on genu valgum. Examples<br>include: |
| | - Fixation of opening wedge high tibial osteotomy,<br>- Fixation of fracture of the medial tibial plateau,<br>- Osteoarthritis of the medial tibiofemoral<br>compartment with genu varum,<br>- Fixation of closing wedge high tibial osteotomy,<br>- Fixation of fracture of the lateral tibial plateau,<br>- Distal femoral varus osteotomy,<br>- Lateral gonarthrosis on genu valgum. |
| PREDICATE DEVICE: | The SURFIX® Knee Osteotomy System is<br>substantially equivalent to the Synthes TomoFix™<br>Osteotomy System (K023941) and the Arthrex<br>Modified Osteotomy System (K014155). |

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### PARISON OF OLOGICA ERISTICS:

The three systems are recommended for fixation of osteotomies, including high tibial osteotomy and femoral osteotomy.

For the Arthrex Modified Osteotomy System, plates and screws are made of Stainless Steel. For the Synthes TomoFix™ Osteotomy System, plates and screws are made of Titanium alloy. The SURFIX® Knee Osteotomy System provides plates made of Stainless Steel and, screws and lock screws made of Titanium alloy or Stainless Steel.

The three systems are fixed with screws.

### UMMARY OF STODIES:

Dynamic tests determining fatigue strength indicate the good mechanical resistance of the SURFIX® Knee Osteotomy System.

Static tests determining bending strength in flexion and twisting of bone plates indicate the similar mechanical behavior of the SURFIX® Osteosynthesis System with a common plate.

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Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines suggesting movement or connection.

AUG 27 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SURFIX Technologies S.A. C/o Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K041601

Trade/Device Name: SURFIX® Knee Osteotomy System Regulation Numbers: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 24, 2004 Received: June 14, 2004

Dear Dr. Estrin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected by the device is substantially equivalent (for the indications ferenced above and haves re and in marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimered pror to rial) 2012-12-12 in accordance with the provisions of the Federal Food, Drug, devices that have been rocksonied require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererors, mains of the Act include requirements for annual registration, listing of general voltario profice, 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 If your device is olaborned (600 w or of ols. Existing major regulations affecting your device can may be subject to basil additions, 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 r lease be act not a 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

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# Page 2 -- Norman Estrin, Ph.D., RAC

comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with all the Act s requirements, merading practice requirements as set CFR Part 807), labeling (21 CFR Part 800), government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 marketing your aviral equivalence of your device to a legally premarket nother in TDA miaing of castion 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 Patting spitiled If you desire specific advice for your act 100 %. 659. Also, please note the regulation entitled, p contact the Office of Comphalled at (501) 37 - 17 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 " Wissolalling by reference to promantee nobilities under the Act from the Division of Small other general informational 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,

Sincerely yours,

Mark N. Milliman

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 1

K041601 510 (k) Number (if known) : SURFIX Knee Osteotomy Device Name :

Indications for Use :

The SURFIX® Knee Osteotomy System is indicated for knee osteotomies including high tibial osteotomy and femoral osteotomy in the cases of osteoarthritis of the medial tibiofemoral compartment with genu varum and lateral gonarthrosis on genu valgum. Examples Include:

- Fixation of opening wedge high tibial osteotomy, .
- Fixation of fracture of the medial tibial plateau, .
- Osteoarthritis of the medial tibiofemoral compartment with genu . varum,
- Fixation of closing wedge high tibial osteotomy, .
- Fixation of fracture of the lateral tibial plateau, ●
- Distal femoral varus osteotomy,
- Lateral gonarthrosis on genu valgum.

OR

Prescription Use

(Per 21 CFR 801.109)

Over -the-counter Use

(Optional format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millhuser

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K04160