UNI-CLIP STAPLE

K991482 · New Deal, S.A. · JDR · Jun 3, 1999 · Orthopedic

Device Facts

• Record ID: K991482
• Device Name: UNI-CLIP STAPLE
• Applicant: New Deal, S.A.
• Product Code: JDR · Orthopedic
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UNI-CLIP® STAPLE is implanted for fixation of bone fractures or for bone reconstructions.

Device Story

UNI-CLIP® STAPLE is a bone fixation device designed for orthopedic procedures. Device features a diamond-shaped geometry that undergoes mechanical deformation; widening the diamond narrows the interaxis of the two legs, providing adjustable and controlled compression across bone segments. Used by surgeons in clinical settings for fixation of fractures or bone reconstructions in the forefoot, midfoot, and hindfoot. Provides stable fixation to facilitate bone healing and stabilization of osteotomies.

Clinical Evidence

Bench testing only. Testing evaluated torque of divergence and strength of compression, confirming resistance to torsion in compliance with selected standards.

Technological Characteristics

Bone fixation staple; material: stainless steel; mechanism: mechanical deformation of diamond geometry to achieve compression; dimensions: various sizes available.

Indications for Use

Indicated for mono or bi-cortical osteotomies in the forefoot; distal or proximal metatarsal osteotomies; fusion of the first metatarsophalangeal joint and the interphalangeal joint; fixation of osteotomies for hallux valgus treatment (e.g., Scarf, Chevron); Akyn type osteotomy; arthrodesis of the base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus; and arthrodesis and osteotomy fixation in the midfoot and hindfoot.

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

• Memory Staple from DePuy, Inc. (K964226)

Submission Summary (Full Text)

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3 1999 JUN

Image /page/0/Picture/1 description: The image shows the logo and contact information for Newdeal SA. The address is 31 Rue de la Convention, Parc d'Activités Garigliano, 38200 Vienne, France. The telephone number is (33) 04 74 78 15 15, and the fax number is (33) 04 74 78 15 1.6.

INTERNET EMAIL : [e-mail]

# 3. SUMMARY OF SAFETY AND EFFECTIVENESS

## A. SPONSOR IDENTIFICATION: NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE

Tél. : [phone] Fax : [phone]

#### B. ESTABLISHMENT REGISTRATION NUMBER:

Pending

K991482

### C. OFFICIAL CONTACT PERSON

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

Tel. : [phone] Fax : [phone]

### D. DATE OF PREPARATION OF THIS SUMMARY: UNI-CLIP® STAPLE E. PROPRIETARY (TRADE) NAME: F. COMMON NAME: Bone fixation staple True compression, adjustable and controlled. G. CLASSIFICATION NAME AND REFERENCE: Staple, Fixation, Bone (21 CFR, Section 888,3040) H. PROPOSED REGULATORY CLASS: Class II DEVICE PRODUCT CODE: I. 87JDR J. PANEL CODE: 21CFR par. 888.3030

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# The UNI-CLIP® STAPLE is designed so that, by DESCRIPTION OF DEVICE: widening the "diamond", mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled, with many choices of size.

The UNI-CLIP® STAPLE is implanted for fixation of INTENDED USE: bone fractures or for bone reconstructions.

INDICATIONS FOR USE:

The UNI-CLIP® STAPLE is indicated for:

- Mono or bi-cortical osteotomies in the forefoot
- Distal or proximal metatarsal osteotomies
- Fusion of the first metatarsophalongeal joint and the interphalangeal joint
- Fixation of the osteotomies for hallux valgus treatment (such as, Scarf, Chevron)
- Akyn type Osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- . Arthrodesis and osteotomy fixation in the Midfoot and Hindfoot

The UNI-CLIP® STAPLE is substantially equivalent to PREDICATE DEVICE: Memory Staple from DePuy, Inc.( K964226) .

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

SUMMARY OF STUDIES

Torque of divergence and strenght of compression the UNI-CLIP® STAPLE was studied and found to have a resistance to torsion in compliance with the selected standard.

Both the UNI-CLIP® STAPLE have the same intended

of use and all are indicated for fixing small fractures or

osteotomies. All are made from stainless steel.

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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is black against a white background.

DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1999

Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. Representing NewDeal SA 9109 Copenhaver Drive 20854 Potomac, Maryland

Re: K991482 UNI-CLIP® Staple Trade Name: Requlatory Class: II Product Code: JDR Dated: April 27, 1999 Received: April 28, 1999

Dear Dr. Estrin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative 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):

Device Name: UNICLIP® STAPLE

Indications for Use:

- . Mono or bi-cortical osteotomies in the forefoot
- . Distal or proximal metatarsal osteotomies
- . Fusion of the first metatarsophalongeal joint and the interphalangeal joint
- Fixation of the osteotomies for hallux valgus treatment (such as, Scarf, Chevron)
- . Akyn type Osteotomy
- . Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Arthrodesis and osteotomy fixation in the Midfoot and Hindfoot

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

biocauto

Sidn-Off) (Division of beneral Restorative Deve Divisic .. 510(k) Number --