CALCAMEA PLATE

K041786 · New Deal, S.A. · HRS · Sep 8, 2004 · Orthopedic

Device Facts

• Record ID: K041786
• Device Name: CALCAMEA PLATE
• Applicant: New Deal, S.A.
• Product Code: HRS · Orthopedic
• Decision Date: Sep 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CALCANEA™ -PLATE is indicated for use in fixation of fractures or osteotomies of the calcaneus.

Device Story

CALCANEA™-PLATE is a low-profile, anatomical titanium plate system designed for calcaneal fracture fixation and osteotomy reconstruction. Device enables restoration of calcaneal height and width; facilitates lateral calcaneal remodeling. System includes plates in three sizes and two types of titanium screws: locking (threaded heads) and variable angle. Screws are self-tapping with smooth tips to minimize soft tissue irritation. Used by orthopedic surgeons in clinical/surgical settings. Plate/screw interface provides low-profile fixation. Color-coded components assist in size identification. Benefits include anatomical fit, stable bone fixation, and reduced soft tissue irritation.

Clinical Evidence

Bench testing only. Mechanical testing conducted to evaluate torsion and bending strength. Results confirmed mechanical characteristics are at least as good as the predicate Synthes Calcaneus Locking Plate (K991407).

Technological Characteristics

Titanium alloy (TiAl6V4) anatomical plate; low-profile design. Fixation via 3.5mm diameter titanium locking and variable angle screws. Self-tapping screw design. Color-coded for size identification. Mechanical properties validated via torsion and bending strength testing.

Indications for Use

Indicated for fixation of fractures or osteotomies of the calcaneus in patients requiring surgical stabilization.

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 Locking Calcaneal Plates (K991407)
• SYNTHES Locking Calcaneal Plates (K020401)
• DEPUY ACE Calcaneal Peri-Articular Plate (K993465)
• DEPUY ACE Calcaneal Peri-Articular Plate (K981775)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Newdeal. The logo consists of the word "newdeal" in a sans-serif font, with a circle to the left of the word. The circle has four dots around it, two of which are solid black and two of which are white with black speckles. The "®" symbol is to the right of the word "deal".

SEP = 8 2004

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10, PLACE D'HELVETIE · 69006 LYON · FRANCE t [phone] ● t [phone] [e-mail] • www.newdeal.info

## SUMMARY OF SAFETY AND EFFECTIVENESS 3.

- SPONSOR IDENTIFICATION: A. NewDeal SA 10, place d'Helvétie 69006 LYON FRANCE
Tél. : [phone] Fax : [phone]

## ESTABLISHMENT REGISTRATION NUMBER: 9615741 B.

- 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] [e-mail]

#### CALCANEA™-PLATE PROPRIETARY (TRADE) NAME: D.

- Plate for calcaneal fracture COMMON NAME: E.
## CLASSIFICATION NAME AND REFERENCE F.

Plate, Fixation, Bone (21 CFR, Section 888. 3030)

- PROPOSED REGULATORY CLASS: Class II G.
- DEVICE PRODUCT CODE: HRS H.
- 87 OR Orthopedic PANEL CODE: I.

0 0007

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K041786
page 2 of 3

#### J. DESCRIPTION OF DEVICE:

The CALCANEA 100 PLATE is a Titanium low profile anatomical plate dedicated for fixation of calcaneal fractures.

The CALCANEATM PLATE enables a reconstruction of height and width of the calcaneus and a possible remodeling to the lateral calcaneus.

Its anatomical design provides optimal bone coverage while its low profile provides a minimal irritation of soft tissues.

The CALCANEA 110 PLATE is available in three different sizes (1-2-3) for optimal anatomical fit. Numerous holes enable a versatile screw fixation.

The fixation is provided by Titanium screws available in two different design : locking screws and variable angle screws.

The locking screws have threaded heads adapted to the threaded holes of the plate whereas the other design provides a variable angle for a versatile fixation.

The range of screws include a diameter of 3.5 mm and a length from 20 mm to 45 mm (by 5 mm). The fixation screws are self tapping with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface.

Both plates and screws present a color code for size identification. The lot number and the reference are marked for easier product traceability.

- The CALCANEA™-PLATE is indicated for use in K. INDICATIONS FOR USE: fixation of fractures or osteotomies of the calcaneus.
- The CALCANEATM-PLATE is similar in design and L. PREDICATE DEVICE: function to the predicates SYNTHES Locking Calcaneal Plates (K991407 - K020401) and the DEPUY ACE Calcaneal Peri-Articular Plate (K993465 - K981775). Based on the information provided in this premarket notification, Newdeal considers the subject devices to be equivalent to the existing DePuy Ace and Synthes calcaneal plates.

# M. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

CALCANEATM-PLATE, the Synthes The Locking calcaneal plates and the DePuy ACE calcaneal plate have same intended of use and are indicated for fixation of

11 11008

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kost 1786 fractures and osteotomies of the calcaneus. Page 303

fractures and osteotomies of the calcaneus.

of CALCANEA™-PLATE and DePuy ACE Both calcaneal plate in Titanium alloy TIAI6V4 whereas the Synthes locking calcaneal plates are manufactured in Stainless steel 316 L.

-All those systems are fixed with 3.0mm, 3.5mm or 4.0mm screws.

## N. SUMMARY Determination of the mechanical characteristics (torsion OF STUDIES: strength, bending strength, comparison with a predicate) of the CALCANEATM -PLATE was conducted.

The various tests performed on the CALCANEA™ Plate were satisfactory and allow marketing this device, which has mechanical characteristics at least as good as the ones of the competitors, among which the Synthes Calcaneus Locking Plate (K991407) defined as a predicate.

### June 28, 2004 DATE OF PREPARATION OF THIS SUMMARY:

1. 1.000

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is the department's logo, which is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 8 2004

NewDeal S.A. C/o Norma F. Estrin, PhD, RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K041786 Trade/Device Name: CALCANEA™ - PLATE Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 28, 2004 Received: July 6, 2004

Dear Dr. Estrin:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed 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 encreations of the enactment date of the Medical Device Amendments, or to conninered process in they 20, 2017) in accordance with the provisions of the Federal Food, Drug, de vices that have been i that do not require approval of a premarket approval application (PMA). and Cosmetic rear (110) that 80 hevice, subject to the general controls provisions of the Act. The r ou may, dicrore, mains of the Act include requirements for annual registration, listing of general ocultive profitive 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 rr your device is elassinod (tional controls. Existing major regulations affecting your device can may or subject to basil at 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intacted and regulations administered by other Federal agencies. You must or uny I out 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 form in the quality by router (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Norma F. Estrin, PhD, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotter will and in your of substantial equivalence of your device of your device to a legally premated predicated 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 If you desire specific at noliance 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 from the Division of Small other general 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 N Millman

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

510(k) Number (if known):

K04/784

CALCANEA™ -PLATE Device Name: Indications for Use:

The CALCANEA™ -PLATE is indicated for use in fixation of fractures or osteotomies of the calcaneus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Mark A. Millerson
Division Sign Off

Division of General, Restorative, and Neurological Devices

.............................................................................................................................................................................. 510(k) Number_