ADJUSTABLE LARGE FIXATOR SYSTEM

K010344 · Synthes (Usa) · KTT · May 3, 2001 · Orthopedic

Device Facts

• Record ID: K010344
• Device Name: ADJUSTABLE LARGE FIXATOR SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: May 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures, osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.

Device Story

Adjustable Large Fixator System is a pre-assembled, mechanically adjustable, unilateral external fixator. Device construct consists of radiolucent PEEK plastic, aluminum, stainless steel, and titanium alloy. Vise clamps accept 4.0-6.0 mm Schanz Screws for bone attachment. Includes Hybrid Adaptor accessory for connection to Synthes Hybrid Ring. Used by surgeons in clinical settings for stabilization of long bone fractures and osteotomies. Device provides mechanical support to bone segments; allows for manual adjustment of fixation construct. Benefits include radiolucency for improved imaging and mechanical adjustability for fracture management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: PEEK resin, aluminum, stainless steel, titanium alloy. Form factor: Pre-assembled, unilateral, mechanically adjustable fixator. Components: Vise clamps for 4.0-6.0 mm Schanz Screws; Hybrid Adaptor accessory. Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for treatment of long bone conditions including fractures, osteotomies, and other bone conditions amenable to unilateral external fixation.

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 Large External Fixator (pre-amendment device)
• EBI DynaFix™ System

Submission Summary (Full Text)

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K010344

## MAY - 3 2001

## 3.0 510(k) Summary

Sponsor:

Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone]

Contact: Bonnie Smith

Device Name: Synthes Adjustable Large Fixator System

Classification: The classification of the Synthes Adjustable Large Fixator System is Class II, as per Title 21 of the Code of Federal Regulations, Sections 888.3030: "Single/multiple component bone fixation appliances and accessories" and 888.3040: "Smooth or threaded metallic bone fixation fastener". The instruments used with this system are considered Class I Exempt, as per 21 CFR 888.4540: Orthopedic manual surgical instruments.

Predicate Device: The predicate device for the Synthes Adjustable Large Fixator System is the Synthes Large External Fixator, (a pre-amendment device). The Adjustable Large Fixator System is similar in design and function to other large fixators that have received 510(k) clearance, including the EBI DynaFix™ System.

The Adjustable Large Fixator System consists of a pre-assembled, Device Description: mechanically adjustable, unilateral fixator and an accessory, the Hybrid Adaptor. The fixator is a one-piece construct comprised of radiolucent plastic and metallic components. The vise clamps of the fixator accept 4.0-6.0 mm Schanz Screws. The Hybrid Adaptor is an accessory to the Adjustable Large Fixator that forms the connection between the fixator and the Synthes Hybrid Ring.

Intended Use: The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures. osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.

Material: The Adjustable Large Fixator is comprised of PEEK resin (radiolucent material), aluminum, stainless steel and titanium alloy. The Hybrid Adaptor is comprised of titanium alloy and stainless steel.

Premarket Notification 510(k): Synthes (USA) Adjustable Large Fixator System CONFIDENTIAL

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Public Health Service

**MAY - 3 2001**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K010344

Trade Name: Adjustable Large Fixator System Regulation Number: 888.4540 Regulatory Class: Class II Product Code: KTT Dated: February 2, 2001 Received: February 5, 2001

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 stated in the enorouse) to ical Device Amendments, or to devices that have been reclassified in encediance 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, condons provisions or active, 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 (Fremaries I Ippevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good 0991 i Pactice 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 mopellish the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

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.

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## Page 2 - Ms. Bonnie J. Smith

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific active rolly of the ostic devices), please contact the Office of Compliance at additionally 607.10 for m This anaglestions on the promotion and advertising of your device, [phone]. Traditionally, 18. quice at [phone]. Also, please note the regulation in prease contact the Ornece or Compilance empremarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and more [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden

Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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## 2.0 Indications for Use Statement

Page _ 1 of _ of _ 1 _ _ 1

510(k) Number (if known):

KOID 344

Device Name:

INDICATIONS:

The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures, osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.

NRO for cmw
(Division Sign-Off)

Synthes (USA) Adjustable Large Fixator System

Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

(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

Premarket Notification 510(k): Synthes (USA) Adjustable Large Fixator System CONFIDENTIAL

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