LARGE UNI-CLIP STAPLE

K061594 · New Deal, S.A. · JDR · Jul 3, 2006 · Orthopedic

Device Facts

• Record ID: K061594
• Device Name: LARGE UNI-CLIP STAPLE
• Applicant: New Deal, S.A.
• Product Code: JDR · Orthopedic
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LARGE UNI-CLIP® 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 staple(s) used should be adapted to the specific indication.

Device Story

LARGE UNI-CLIP® STAPLE is a metallic bone fixation device; designed for hand and foot surgery. Principle of operation involves mechanical deformation of a diamond-shaped staple; widening the opening narrows the interaxis of the two legs to provide adjustable, controlled bone compression. Used by surgeons in clinical settings for fracture management, arthrodesis, and osteotomy fixation. Provides stable bone fixation to facilitate healing and reconstruction. Output is the physical compression and stabilization of bone segments.

Clinical Evidence

Bench testing only. Mechanical tests were performed to compare the mechanical properties of the LARGE UNI-CLIP® staples to the predicate device (K011716). Results demonstrated that the mechanical properties are similar.

Technological Characteristics

Material: 316L Stainless Steel conforming to ISO 5832-1, ASTM F138, and ASTM F139. Design: Diamond-shaped staple with two legs; mechanical deformation provides compression. Non-powered, mechanical fixation device.

Indications for Use

Indicated for bone fracture fixation or bone reconstruction in hand or foot surgery, including arthrodesis, fracture management, mono/bi-cortical osteotomies, and Hallux Valgus treatment (e.g., Scarf, Chevron).

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

• UNI-CLIP® staples (K011716)

Submission Summary (Full Text)

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K061594

Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo consists of the word "newdeal" in a bold, sans-serif font, with a circle of five black dots to the left of the word. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, sans-serif font. The logo is simple and modern, and it effectively communicates the company's name and affiliation.

JUL - 3 2006

## 510(k) SUMMARY

- A. Submitter's Name and Address: Newdeal SAS 10, place d'Helvétie 69006 LYON France Tel.: [phone] Fax: [phone] ESTABLISHMENT REGISTRATION NUMBER: 9615741
#### B. Contact Person:

Morgane GRENIER Regulatory and Clinical Affairs Manager Newdeal SAS 10, place d'Helvétie 69006 LYON France Tel: [phone] Fax: + 33 4 37 47 51 52

- C. Date Summary Prepared: June 7, 2006
### D. Name of Device: Proprietary Name: LARGE UNI-CLIP® STAPLES

Common Name: Staple, fixation, bone

## Classification Name and Reference:

Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)

Device Product Code: JDR

Proposed Regulatory Class: Class II

Panel: Orthopedic

#### E. Device Description

The LARGE UNI-CLIP® STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs.

The surgeon can obtain a true compression, adjustable and controlled with many choice of size.

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The LARGE UNI-CLIP® STAPLE is made from 316L Stainless Steel that conforms to ISO 5832-1 and ASTM F138 & F139 standards.

#### Indications for Use F.

The LARGE UNI-CLIP® STAPLE 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 staple(s) used should be adapted to the specific indication.

#### G. Substantial Equivalence

The new LARGE UNI-CLIP® staples are substantially equivalent to commercially marketed device, UNI-CLIP® staples, K011716.

#### H. Comparison of Technological Characteristics

The modified device has the same fundamental scientific technology and intended uses as the predicate device.

The modified staple has the following similarities to those which previously received 510(k) concurrence:

- Same intended use ।
- Same materials -
- Same Instructions for Use -
- Same basic design -
- Same manufacturing process -

#### I. Summarv of Studies

Mechanical tests have been carried out. Results have shown that the mechanical properties of the LARGE UNI-CLIP® staples are thus similar to the properties of the unmodified device, UNI-CLIP® staples, K011716.

#### J. Conclusion

The new LARGE UNI-CLIP® staples are substantially equivalent to commercially marketed device, UNI-CLIP® staples, K011716.

The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.

## B-002

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Newdeal SAS % Integra LifeSciences Corporation Ms. Judith E. O'Grady Sr. Vice President, Regulatory and Clinical Affairs, Quality Assurance 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K061594 Trade/Device Name: The LARGE UNI-CLIP® Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulation Class: II Product Code: JDR Dated: June 7, 2006 Received: June 9, 2006

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 cnactment 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

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## Page 2 - Ms. Jennifer Reich

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 yours,

Surbaye Meelus

Mark N. 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):

Device Name: LARGE UNI-CLIP®

## Indications For Use:

The LARGE UNI-CLIP® 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 staple(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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Julian Bucher

Division of General. Restorative. and Neurological Devices

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510(k) Number 20161594