NEWDEAL COMPRESSION PLATE

K070447 · Newdeal Sas · HRS · Mar 29, 2007 · Orthopedic

Device Facts

• Record ID: K070447
• Device Name: NEWDEAL COMPRESSION PLATE
• Applicant: Newdeal Sas
• Product Code: HRS · Orthopedic
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Newdeal Compression Plate is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery - Fractures management in the foot or hand - Mono or Bi-cortical osteotomies in the foot or hand - Distal or proximal metatarsal or metacarpal osteotomies - Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) The size and number of plate(s) used should be adapted to the specific indication.

Device Story

Metallic bone fixation plate for hand and foot surgery. Device utilizes mechanical deformation of a diamond-shaped 'eye' opening to provide compression between bone fragments; rigidity maintained via locking system consisting of screws and washers. Available in 2 or 4-hole configurations with varying interaxis lengths. Operated by surgeons in clinical settings to stabilize bone during healing or reconstruction. Output is physical stabilization of bone segments. Benefits include facilitated fusion and fracture healing.

Clinical Evidence

Bench testing only. Mechanical properties compared to predicate device (Large UNI-CLIP, K061594) to verify performance.

Technological Characteristics

Metallic bone fixation plate, screws, and washers. Materials: Titanium alloy Ti-6Al-4V or 316L Stainless Steel. Features diamond-shaped 'eye' for compression and locking screw/washer system. Available in 2 or 4-hole configurations; interaxis 20, 25, or 30 mm. Provided sterile or non-sterile.

Indications for Use

Indicated for bone fracture fixation or bone reconstruction in the hand or foot, including arthrodesis, fracture management, and osteotomies (e.g., Hallux Valgus treatment).

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

• Wright Medical Technology Compression Plate (K051908)
• Newdeal Large UNI-CLIP Staple (K061594)

Reference Devices

• UNI-CLIP (K011716)
• Surfix Knee Osteotomy system (K041601)
• Newdeal Lisfranc Plates (K060474)
• Newdeal Lapidus Plates (K060476)
• Newdeal TTC Plates (K060473)

Submission Summary (Full Text)

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K070447 1g 2

#### 510(K) SUMMARY

#### Newdeal Compression Plates

MAR 2 9 2007

## Submitter's name and address:

Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: [phone] Fax: [phone]

#### Contact person and telephone number

Morgane Grenier Director of Regulatory and Clinical Affairs - EMEA Newdeal SAS 10, place d'Helvétie 69006 Lyon, France Tel: [phone] Fax: [phone]

#### Alternate Contacts

## Authorized Agent in the United States

Judith E. O'Grady, RN, MSN Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: [phone] Fax: [phone] E-mail: [e-mail]

## Date Summary was prepared:

February 9, 2007

## Name of the device:

| Proprietary Name: | Newdeal Compression Plate |
|-----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (21CFR 888.3030) |
| Device Product Code: | HRS |
| Classification Panel: | Orthopedic |

## Substantial Equivalence:

The Newdeal Compression Plate is substantially equivalent to the Wright Medical Technology Compression Plate, K051908 and the Newdeal Large UNI-CLIP Staple, K061594.

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#### Device Description:

The Newdeal Compression Plate will offer the combination of two concepts:

- By widening the "eye" (diamond shaped opening) on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. This is the same principle as the UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594).
- . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking system of the
- . following predicate device: Surfix Knee Osteotomy system (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476) and Newdeal TTC Plates (K060473).

The plate will be available with 2 or 4 holes and with interaxis of 20, 25 or 30 mm.

Fixation of the Newdeal Compression Plate is provided by two or four Screws & washers, which are the same as for the Lapidus Plate (K060474) and Lisfranc Plate (K060476).

Plates, screws and washers will be provided either sterile or non-sterile.

The Locking System (Screw + washer) will be made from Titanium alloy Ti-6Al-4V or 316L Stainless Steel.

#### Intended Use:

The Newdeal Compression Plate is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

- Arthrodesis in hand or foot surgery
- Fractures management in the foot or hand
- Mono or Bi-cortical osteotomies in the foot or hand
- Distal or proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

The size and number of plate(s) used should be adapted to the specific indication.

#### Testing and Test Results:

Mechanical tests have been carried out and results were compared with the predicate device, Large UNI-CLIP (K061594).

All the results show us that the Newdeal Compression Plate have mechanical properties compatible with their intended uses.

#### Conclusion

The Newdeal Compression Plate is substantially equivalent to commercially marketed devices, the Wright Medical Technology Compression Plate, K051908 and the Newdeal Large UNI-CLIP Staple, K061594.

The Newdeal Compression Plate does not raise any new issues of scientific technology, safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Newdeal SAS % Integra LifeSciences Corporation Judith O'Grady, RN, MSN Senior Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

MAR 2 9 2007

Re: K070447

Trade/Device Name: Newdeal Compression 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: February 9, 2007 Received: February 15, 2007

Dear Ms. O'Grady:

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

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Page 2 - Judith O'Grady, RN, MSN

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.

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 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 vours.

Reuben Mueller

Mark N. Melkerson 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):

14070447

Newdeal Compression Plate Device Name:

Indications For Use:

The Newdeal Compression Plate is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

- Arthrodesis in hand or foot surgery
- Fractures management in the foot or hand
- Mono or Bi-cortical osteotomies in the foot or hand
- Distal or proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

The size and number of plate(s) used should be adapted to the specific indication.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

currence of CDRH, Office of Device Evaluation (ODE)

Choubare buchip

Division Sign-C Division of General, Restorative, and Neurological Devices

**510(k) Number** k070447

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