J-FX CERCLAGE SYSTEM

K971682 · Johnson & Johnson Professionals, Inc. · LRN · Jun 27, 1997 · Orthopedic

Device Facts

• Record ID: K971682
• Device Name: J-FX CERCLAGE SYSTEM
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: LRN · Orthopedic
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.

Device Story

J-Fx Cerclage System comprises stainless steel or cobalt-chromium alloy cables and sleeves; used for bone fixation and reinforcement. System includes manual instrumentation: cable passer, tensioner, sleeve crimper, and cable cutter. Operated by surgeons in clinical/OR settings. Implants provide mechanical stabilization of bone fragments or sternum; secured via crimped sleeve mechanism. Benefits include structural support for fractures and surgical closures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Implants: Stainless steel or cobalt-chromium alloy cables (1.6mm or 2.0mm diameter) and sleeves. Fixation: Crimped sleeve mechanism. Instrumentation: Manual cable passer, tensioner, crimper, and cutter. Non-sterile or sterile (implied by surgical use).

Indications for Use

Indicated for general orthopaedic repairs, including bone reinforcement, greater trochanter reattachment, long bone fracture fixation with grafting, patellar fracture fixation, and sternal closure post-open heart surgery.

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

• OSTEO-CLAGE™ Cable system (K921480)
• DALL-MILES Trochanter Cable Grip System (K934058)
• FX-CABLELOK™ System (K935646)

Submission Summary (Full Text)

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JUN 2
K971682
Johnson-Johnson
PROFESSIONAL, INC.

510(k) Summary

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person: John D. Ferros Phone:[phone] Fax: [phone]

# Name of Device

Classification Name: Bone Fixation Cerclage has been placed in Class II by the FDA under 21 CFR 888.3010. This falls under the Orthopaedics panel/87. Common Name: Cerclage Fixation Device.

Trade Name/Proprietary Name: J-Fx Cerclage System Performance Standards: No performance standards have been developed for this device.

# Predicate Device

- OSTEO-CLAGE™ Cable system by Acumed, Inc. (K921480) ●
- DALL-MILES Trochanter Cable Grip System by Howmedica. (K934058)
- FX-CABLELOK" System by Biodynamic Technologies, Inc. (K935646) .

# Description of Device

The J-Fx Cerclage System consists of implants and instruments. The implants are cables and sleeves in both stainless steel and cobalt chromium alloy. The cables are available in two diameters, 1.6 mm and 2.0 mm. Instrumentation is also part of the system to assist in the placement of the implants.

### Intended Use

The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.

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# Technological Characteristics Compared to Predicate Device

| | J-Fx | OSTEO-<br>CLAGE | DALL-MILES | FX-<br>CABLELOK |
|-----------------------------------|-------------------|-------------------|-------------------|-------------------|
| Design | | | | |
| Flexible Cable<br>Fixation Method | Yes | Yes | Yes | Yes |
| | Crimped<br>Sleeve | Crimped<br>Sleeve | Crimped<br>Sleeve | Crimped<br>Sleeve |
| Chamfered<br>Sleeve Hole<br>Edges | Yes | Yes | ? | ? |
| Cable Thickness | 2mm or<br>1.6mm | 2mm or<br>1.6mm | 2mm or<br>1.6mm | 2mm |
| Uses: | | | | |
| Cable Passer | Yes | Yes | Yes | Yes |
| Cable<br>Tensioner | Yes | Yes | Yes | Yes |
| Sleeve<br>Crimper | Yes | Yes | Yes | Yes |
| Cable Cutter | Yes | Yes | Yes | Yes |
| Materials | | | | |
| Cable | Co-Cr or SS | Co-Cr or SS | Vitallium® | Co-Cr |
| Sleeve | Co-Cr or SS | Co-Cr or SS | Vitallium® | Co-Cr |

Similarities and Differences Matrix

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 1997

Mr. John D. Ferros ·Senior Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re : K971682 J-Fx Cerclage System Requlatory Class: II Product Code: LRN Dated: May 5, 1997 Received: May 6, 1997

Dear Mr. Ferros:

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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Fractice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 - Mr. John D. Ferros

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,

Marin Schroeder, MS, PT
Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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K971682 510(k) Number (if known):

Device Name: J-Fx Cerclage System . . . . . . . .

Indications for Use:

The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maie H. Schroeder msPTfa cmu

(Division Sign-Off) Division of General Restorative Devices 510(k) Number Y

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use OR

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