SYNTHES IN-SITU BENDER/CUTTER

K021458 · Synthes (Usa) · HRS · Jul 24, 2002 · Orthopedic

Device Facts

• Record ID: K021458
• Device Name: SYNTHES IN-SITU BENDER/CUTTER
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Jul 24, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes (USA) In-Situ Bender/ Cutter is intended for use with Synthes resorbable fixation products in forming and/or cutting plates, meshes, sheets, screws, and tacks in-situ before, during, and after implantation.

Device Story

Battery-powered, disposable, pen-like handheld device; used by clinicians during surgical procedures involving resorbable fixation products. Features plastic housing with interchangeable tips for bending or cutting resorbable plates, meshes, screws, and tacks. Operates via internal battery, wiring, and switch mechanism. Facilitates intraoperative adjustment of fixation hardware to improve fit or placement. Single-use only; provided sterile.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered, handheld, pen-like form factor. Plastic housing with interchangeable metal tips for bending/cutting. Disposable, single-use, sterile. Electromechanical actuation.

Indications for Use

Indicated for use with Synthes resorbable fixation products to form or cut plates, meshes, screws, and tacks in-situ before, during, and after initial implantation.

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

• MacroPore MacroSorb OS Protective Sheet and MacroPore DX screws and plates
• Synthes Resorbable Fixation System
• Synthes Resorbable Meshes and Sheets

Submission Summary (Full Text)

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JUL 24 2002

Ko 2/458 page.

## Summary of Safety and Effectiveness Information [510(k) Summary] 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Matthew M. Hull |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) In-Situ Bender/ Cutter |
| REGULATION &<br>CLASSIFICATION: | Accessory to: Class II § 872.4760 -- Bone plate and § 888.3030 -<br>Single/multiple component metallic bone fixation appliances and<br>accessories. |
| PREDICATE DEVICE: | Power Pen accessory: MacroPore MacroSorb OS Protective Sheet and<br>-<br>MacroPore DX screws and plates.<br>Synthes Resorbable Fixation System & Synthes Resorbable Meshes and<br>-<br>Sheets. |
| DEVICE DESCRIPTION: | The Synthes In-Situ Bender/ Cutter is a battery-powered disposable device<br>for use with Synthes resorbable fixation products. The device consists of a<br>pen-like welded body that will house the batteries, wiring, and switch. The<br>plastic housing will come with changeable tips for bending or cutting the<br>resorbable implants. The device will be packaged sterile and labeled for<br>single use only. |
| INTENDED USE: | The Synthes (USA) In-Situ Bender/ Cutter is intended for use with Synthes<br>resorbable fixation products in forming and/or cutting plates, meshes,<br>sheets, screws, and tacks in-situ before, during, and after implantation. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The Synthes In-Situ Bender/ Cutter has the same technological<br>characteristics as the MacroPore predicate device identified above. Both are<br>accessories for resorbable plating systems. The bodies of both devices are<br>plastic with interchangeable cutting and bending tips. Both devices are<br>battery powered and disposable, labeled for single-use only. |

Confidential

Page Number

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2002

Mr. Matthew M. Hull. RAC Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsvlvania 19301

Re: K021458 Trade/Device Name: Synthes (USA) In-Situ Bender/Cutter Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II

Product Code: HRS Dated: May 6, 2002 Received: May 7, 2002

Dear Mr. Hull:

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 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.

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Page 2 - Mr. Matthew M. Hull, RAC

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

l Mark A. Milburn

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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## 8.0 Indications for Use Statement

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Device Name: Synthes (USA) In-Situ Bender/ Cutter

Indications:

The Synthes (USA) In-Situ Bender/ Cutter is intended for use with Synthes resorbable fixation products in forming and/or cutting plates, meshes, screws, and tacks in-situ before, during, and after initial implantation.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Mark A. Melhurn

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

K021458
510(k) Number

Prescription Use ડી (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Synthes (USA) In-Situ Bender/Cutter 510(k) Confidential

Page Number

00011