← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K070617

# CANNULATED SCREW (K070617)

_Fournitures Hospitalieres Industrie · HWC · Jun 14, 2007 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K070617

## Device Facts

- **Applicant:** Fournitures Hospitalieres Industrie
- **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md)
- **Decision Date:** Jun 14, 2007
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3040
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The screws are used to fix bone fragments of the foot together for osteosynthesis.

## Device Story

Cannulated screws (self-compression and arthrodesis models) designed for foot bone fragment fixation; manufactured from titanium alloy. Device features hexagonal head; requires specific guide pin for surgical placement. Used by surgeons in clinical/OR settings for osteosynthesis. Provides mechanical stabilization of bone fragments to facilitate healing. Bench testing confirms resistance to torsion per NF F 90-414 standard.

## Clinical Evidence

Bench testing only. Rupture torque testing performed and compared against French Standard NF F 90-414 requirements; device found to be in compliance. No clinical data provided.

## Technological Characteristics

Titanium alloy (ISO 5832/3, ASTM F 136); cannulated design with hexagonal head; available in various lengths (10-40mm). Mechanical fixation device; non-powered. Sterilization method not specified.

## Regulatory Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Predicate Devices

- Snap-off screws ([K041456](/device/K041456.md))
- BOLD® screw ([K990622](/device/K990622.md) and [K011262](/device/K011262.md))
- Scarf Thread-Head screw ([K971070](/device/K971070.md) and [K962236](/device/K962236.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

CANNULATED SCREWS 510(k) Premarket Notification

K070617

## 510 (K) SUMMARY CANNULATED SCREWS

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92

## SUBMITTER :

Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER - FRANCE Tel: (33) 2.98.55.68.95 Fax: (33) 2.98.53.42.13

# COMPANY CONTACT :

Franck HUNT General Manager Phone number : 33.2.98.55.68.95 Fax number : 33.2.98.53.42.13

Date prepared : January 31th 2007

#### DEVICE NAME :

Trade name : CANNULATED SCREWS Common name : Cannulated screw Classification name : Smooth or threaded metallic bone fixation fastener 21 CFR 888,3040

## PREDICATE DEVICES :

Manufacturer : Fournitures Hospitalieres Industrie Device Trade Name : Snap-off screws 510 (K) : K041456 August 25" 2004 Date claered :

Manufacturer : NewDeal SA Device Trade Name : BOLD® screw 510 (K) : K990622 and K011262 June 1516 2001 and April 29th 1999 Date clacred :

Manufacturer : MEDINOV-AMP Device Trade Name : Scarf Thread-Head screw 510 (K) : K971070 and K962236 July 9th 1997 and September 20th 1996 Date claered :

{1}------------------------------------------------

## DEVICE DESCRIPTION:

This range of screws for foot includes several types of cannulated screws made of titanium alloy (according to ISO 5832/3 and ASTM F 136) with an hexagonal head.

- The cannulated self-compression screw, and

- The cannulated arthrodesis screw.
A specifical guide pin is used for implant placement. The following table shows our range of cannulated screws:

| Products                              | Lengths                                                 |
|---------------------------------------|---------------------------------------------------------|
| Cannulated self-<br>compression screw | 10, 12, 14, 16, 18, 20, 22, 24,<br>26, 28, 30, 32, 34mm |
| Cannulated<br>arthrodesis screw       | 28, 30, 32, 34, 36, 38, 40mm                            |

### INDICATIONS FOR USE:

The screws are used to fix bone fragments of the foot together for osteosynthesis.

## PREDICATE DEVICES:

Numerous cannulated screws for foot have been cleared for commercial distribution by the Food and Drug Administration (FDA). We have selected two predicate devices based upon interded uses, material used in device manufacturing and design features.

These predicate devices are:

- Snap-off screws (K041456) manufctured by FH Industrie -
n BOLD Cannulated Compression screw (K990622 and K011262), manufactured by Newdeal.

Scarf Thread-Head screw (K971070 and K962236) manufactured by Medinov-AMP

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The cannulated screws have the same intended use and substantial similar indications for use as the predicate devices. They are all made of the same material (titanium alloy), are aveilable in similar diameters and lengths, with similar designs.

### PERFORMANCES:

-

Rupture torque was performed on our cannulated screws and was compared with the requirements of the French Standard NF F 90-414 and found to have a resistance to torsion in compliance with the selected standard.

Risk to health have been addressed through the specified materials, Processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practises Regulations, questions, qu

## CONCLUSION;

All these elements show the safety and effectiveness of our product. The cannulated screws are substantially equivalents to the selected predicate devices in terms of intended use, safety, and effectiveness.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fournitures Hospitalieres Industrie c/o Ms. Patricia Donnard Regulatory Affairs Manager 6 Rue Nobel Z.I. de Kernevez 29000 Quimper, France

JUN 1 4 2007

Re: K070617

Trade/Device Name: Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 7, 2007 Received: May 16, 2007

Dear Ms. Donnard:

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.

{3}------------------------------------------------

Page 2 -- Ms. Patricia Donnard

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 (240) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or on the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Jubane breln

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

CANNULATED SCREWS 510(k) Premarket Notification

# Indications for Use

510(k) Number (if known):

K070617

Device Name:

CANNULATED SCREWS The complete range of screws indicated for the foot includes the two following models :

the cannulated arthrodesis screw ; and រ

the cannulated self-compression screw. -

Indications for Use:

The screws are used to fix bone fragments of the foot together for osteosynthesis.

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 OF NEEDED) ﮯ

|                                                  | .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | .#����������������������������������������������������������������������������������������������������������������������������������������������������������������������������<br><br> |  |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| and and the cases of the county of the county of |                                                                                                                                                                                     |                                                                                                                                                                                        |  |

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative,

and Neurological Devices

Page _________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number k070617

21/35

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K070617](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K070617)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com