Ø 1.5 and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX are used for plate fixation fasteners in trauma and constructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; orbital floor fractures; trauma of the midface or craniofacial skeleton and reconstructive procedures of the midface or craniofacial skeleton.

Ø 2.0 mm screw models of BioSorb™ FX can be used for plate fixation fasteners with BioSorb™ 2.0/2.4 O/M plates in trauma and reconstructive procedures in the midface, maxilla and mandible. Especially in mandible BioSorb™ FX 2.0/2.4 O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).

Device Description

Ø 1.5mm and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families. Originally the screw head design of Ø 1.5 and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families was designed as a crosshead screw. Further development of head design for easier insertion of 0 1.5mm and 2.0mm screw models continued and finally new head design with outer attachment of screw driver was finalized. The main purposes were improvement of installation properties without sacrificing torsion properties of the screw model. The revision of head design has no effect on intended use, principles of operation, production methods, raw material or sterilization. The screw drivers are revised accordingly, but other parts of instrumentation are remaining unchanged.

AI/ML Overview

This 510(k) summary describes a modification to an existing medical device, specifically screw head redesigns for bioabsorbable fixation fasteners. As such, the submission focuses on demonstrating substantial equivalence to the predicate devices rather than proving a new device meets specific acceptance criteria through a clinical study. The provided text does not include the information requested regarding conventional acceptance criteria and a study proving those criteria are met, as this type of submission is for device modification and substantial equivalence.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document focuses on explaining that the new screw head design has no effect on intended use, operating principles, production methods, raw materials, or sterilization, and thus is substantially equivalent to the previously cleared devices. It lists contraindications and indications for use, but these are for the device family as a whole and not specific to demonstrating performance of the new head design against defined acceptance criteria.

Summary

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

K042517

510(k) Summary Linvatec Biomaterials Ø 1.5mm and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families

Submitter's Name, Address, Telephone Number, and Contact Person

Linvatec Biomaterials Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: Facsimile: 358-3-316 5629

Date prepared: August 6th, 2004

Name of the device:

A.	Trade or Proprietary Name:	BioSorb™ FX and BioSorb™ PDX1.5 and 2.0 Screws
B.	Common Name:	Bioabsorbable fixation fasteners, used with plates
C.	Classification Name:	Biodegradable fixation fastener, used with plates (Product code JEY)

Predicate Devices:

The predicate devices are the previously cleared Linvatec Biomaterials (the previous Bionx Implants) diameter 1.5mm and 2.0mm screw type fasteners, which are used with bioabsorbable plates of the same products families BioSorb™ FX 1.5/2.0 (K982139), BioSorb™ FX 2.0/2.4 O/M (K982721, K011569) and BioSorb™ PDX (K000836).

Originally the screw head design of Ø 1.5 and 2.0mm screw models of BioSorb™ FX and BioSorb™ PDX product families was designed as a crosshead screw. Further development of head design for easier insertion of 0 1.5mm and 2.0mm screw models continued and finally new head design with outer attachment of screw driver was finalized. The main purposes were improvement of installation properties without sacrificing torsion properties of the screw model.

The revision of head design has no effect on intended use, principles of operation, production methods, raw material or sterilization. The screw drivers are revised accordingly, but other parts of instrumentation are remaining unchanged.

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

K-120517

Substantial Equivalence:

The new Ø 1.5 and 2.0mm screw model has the following similarities to the cleared models of BioSorb™ FX 1.5/2.0 (K982139), BioSorb™ FX 2.0/2.4 O/M (K982721, K011569) and BioSorb™ PDX (K000836):

has the same indicated use -
uses the same operating principle -
incorporates the same basic design of thread -
utilizes the same basic dimensions -
is manufactured by machining -
is packaged and sterilized using the same materials and processes -
has the same shelf life

In summary, the new head design described in this notification is, in our opinion, substantially equivalent to the predicate device.

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

Contraindications are as follows for Ø 1.5 and 2.0mm screw models of BioSorb™ FX 1.5/2.0 and BioSorb™ PDX product lines:

The mandible or continuity defects in load bearing areas 1.
Situations where internal fixation is otherwise contraindicated, e.g. active or 2. potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g. alcoholism).
Patients with suspected or known allergy to implant materials. 3.

Contraindications for BioSorb™ FX 2.0/2.4 O/M System product lines are as follows:

Mandibular tumor resection 1 .
Situations where internal fixation is otherwise contraindicated, e.g. active or 2. potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g. alcoholism).
Significant comminuted fractures including significant bone loss of the 3. mandible.
Intermaxillary fixation without an appropriate external fixation by other 4. means.
1. Patients with suspected or known allergy to implant materials.

(Please do not write below this line - continue on another page is needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-off

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number_ K142517

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

2/2

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle with three stripes extending from its wing, symbolizing growth and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 - 2004

Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials, Limited P.O. Box 3 Fin-33721 Tampere, FINLAND

Re: K042517

R042517
Trade/Device Name: Ø 1.5mm and 2.0mm BioSorb™ FX and BioSorb™ PDX Screws Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 4, 2004 Received: September 15, 2004

Dear Ms. Annala:

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.

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

Page 2 - Ms. Annala

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. or the For of ally I 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 ting instills (2 = = set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), n free contact the Office of Compliance at (240) 276-0115. 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE

510(K) Number (if known): _KO4 2517

Device Name:

Ø 1.5mm and 2.0mm BioSorb™ FX and BioSorb™ PDX Screws

Indications for Use:

(Please do not write below this line - continue on another page is needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-off

Division of Dental, Infection Control, and General Hospital Devices KA 25 17 510(k) Number

Prescription Use ----------X

Over-The-Counter Use OR

(Per 21 CFR 801.109)

Susan Runner

on of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

1/2

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.