BOLD SCREW

• K Number: K990622
• Device Name: BOLD SCREW
• Manufacturer: NEWDEAL S.A.
• Date Cleared: 1999-04-29 ( 63 days)
• Product Code: HWC , 87H
• Regulation Number: 888.3040
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K931155 , K792022
• Predicate For: K070617

Intended Use

The BOLD ® SCREW is indicated for fixing the elective osteotomics of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include:

• · Mono or Bi-cortical osteotomies in the forefoot
• · Distal or proximal metatarsal osteotomics
• · Weil osteotomy
• · Fusion of the first metatarsophalangeal joint and interphalangeal joint.
• · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, ... etc.)
• · Akin type ostcotomy
• · Arthrodesis base first metatarsal cunciform joint to reposition and stabilize metatarsus varus primus

Device Description

The BOLD® SCREW is a cannulated screw made of a Titanium alloy. Its design includes a non-threaded shaft and a screw tip. Screws come in lengths of 10-34 mm.

AI/ML Overview

The document provided is a 510(k) summary for a medical device (BOLD® SCREW) seeking substantial equivalence to predicate devices, not a study report detailing acceptance criteria and performance data for an AI/ML device. Therefore, it does not contain the information requested in points 1 through 9, which are typically found in studies for AI/ML device evaluations.

The document primarily focuses on:

• Sponsor and contact information
• Device identification (name, classification, codes)
• Description of device components and material
• Intended use and indications for use
• Predicate devices for comparison
• Comparison of technological characteristics to predicate devices
• A brief mention of a mechanical study (rupture torque)
• FDA's substantial equivalence determination letter

Regarding the mechanical study mentioned:

A study on the rupture torque of the BOLD® SCREW was performed.

• Acceptance Criteria: The device needed to comply with the French Standard Nº NF-F-90-414 for resistance to torsion.
• Reported Device Performance: The BOLD® SCREW was "found to have a resistance to torsion in compliance with the selected Standard."

However, this is a mechanical performance study of a bone screw, not a study of an AI/ML device, and thus doesn't include the detailed "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, AUC, etc., or details about ground truth, expert consensus, sample sizes for training/test sets, or MRMC studies).

Summary

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Image /page/0/Picture/0 description: The image shows a company logo and contact information. The logo says "newdeal" in a stylized font. Below the logo is the company name "NEWDEAL SA" and address "31 RUE DE LA CONVENTION, PARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE". The phone number is TEL: [phone] and the fax number is FAX: [phone].

INTERNET EMAIL : [e-mail]

K990622

SUMMARY OF SAFETY AND EFFECTIVENESS 3.

SPONSOR IDENTIFICATION: A.

NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE

Tél. : [phone] Fax : [phone]

B. ESTABLISHMENT REGISTRATION NUMBER: Pending

OFFICIAL CONTACT PERSON C.

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

Tel. : [phone] Fax : [phone]

DATE OF PREPARATION

OF THIS SUMMARY :

February 17, 1999

BOLD® SCREW D. PROPRIETARY (TRADE) NAME:

• E. COMMON NAME: Bone fixation screw . Cannulated compression screw
• CLASSIFICATION NAME AND REFERENCE F. Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040)

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include:

• PROPOSED REGULATORY CLASS: D.
  • DEVICE PRODUCT CODE: 87HWC
• E. PANEL CODE: 870R r.

DESCRIPTION OF DEVICE:

The BOLD® SCREW is a cannulated screw made of a Titanium alloy. Its design includes a non-threaded shaft I italidin andy. In screw tip. Screws come in lengths of 10-34 mm.

Class II

The BOLD® SCREW is intended to be implanted for fixation of bone fractures or for bone reconstructions.

The BOLD® SCREW is indicated for fixing the

interphalangeal joint.

· Weil osteotomy

· Akin type osteotomy

elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples

· Mono or Bi-cortical ostcotomies in the forefoot · Distal or proximal metatarsal osteotomies

· Fusion of the first metatarsophalangeal joint and

· Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, ... etc.)

· Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus

INDICATIONS FOR USE:

INTENDED USE:

PREDICATE DEVICE:

The BOLD® SCREW is substantially equivalent to the Scarf Thread-head Screw (DePuy) (K931155) and the Herbert-Whipple Bone Screw (Zimmer) (K792022)

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

SUMMARY OF STUDIES:

Both the BOLD® SCREW, the Scarf Thread-head Screw and the Herbert-Whipple Bone Screw have the same intended use and all are indicated for fixing small fractures or osteotomies. All are made from Titanium alloys. The BOLD® SCREW, the Herbert-Whipple and the Scarf Thread-head Screw have a non-threaded segment. The thread pitch of the Scarf screw differs slightly while the BOLD® SCREW has a double pitch at the tip of the screw compared to the head. Both have a thread head and a hexagonal socket. The Scarf Threadhead Screw, the BOLD® SCREW and the Herbert-Whipple screw are all cannulated and are topped with a hexagonal socket.

Rupture torque of the BOLD® SCREW was compared with requirements of the French Standard Nº NF-F-90-414 and found to have a resistance to torsion in compliance with the selected Standard.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 199

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

K990622 Re: Bold® Screw Trade Name: Regulatory Class: II Product Code: HWC Dated: February 17, 1999 February 25, 1999 Received:

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. ದ 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 regulation (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

K990622 510(k) Number (if known):

BOLD® SCREW Device Name:

Indications for Use:

The BOLD ® SCREW is indicated for fixing the elective osteotomics of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include:

• · Mono or Bi-cortical osteotomies in the forefoot
• · Distal or proximal metatarsal osteotomics
• · Weil osteotomy
• · Fusion of the first metatarsophalangeal joint and interphalangeal joint.
• · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, ... etc.)
• · Akin type ostcotomy
• · Arthrodesis base first metatarsal cunciform joint to reposition and stabilize metatarsus varus primus

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

× Prescription Use Use (Per 21 CFR 801.109)

OR

Over-the Counter

Format 1-2-96)

P. Coello

(Optional

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number R990622

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.