The Osteo 5.0mm Cannulated Screw System is indicated for ligament fixation and long and small bone fracture fixation, which may include the following:

Fixation of intermediate-sized fragments in fractures such as: .
- proximal and distal humerus fractures
- fractures of the olecranon process
- femoral fractures
- tibial plateau and metaphyseal fractures of the proximal and distal tibia
- medial and lateral malleolar and pilon fractures
- os calcis, talar, and patellar fractures -
. Ligament fixation of the proximal humerus
. Fractures of the pelvis and acetabulum
. Arthrodesis of the tarsals

Device Description

The Osteo 5.0mm Cannulated Screw System consists of 5.0mm thread diameter self-tapping cannulated screws of varying lengths and one washer, the use of which is optional. The 5.0mm screw has a thread diameter of 5.0mm, a shaft diameter of 3.2mm, a head diameter of 6.0mm, and a cannulation diameter of 2.0mm. The washer for the 5.0 screws has an outer diameter of 8.0mm, an inner diameter of 4.5mm, and a thickness of 1.0mm. The surfaces of the screws and washers are anodized with a Type II coating. The screws and washers are provided both sterile and non-sterile.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Osteo 5.0mm Cannulated Screw System), not a study analyzing its performance against acceptance criteria. The document establishes substantial equivalence to predicate devices, which is the basis for FDA clearance in this pathway. Therefore, the requested information regarding acceptance criteria, device performance, study design, and specifics about ground truth and expert involvement is not available within this document.

The provided text describes the device, its intended use, and states its substantial equivalence to existing predicate devices (Synthes Titanium 4.5mm Cannulated Screw and ACE Medical Titanium Cannulated Screw and Reconstruction Plate System). The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed.

In a 510(k) submission seeking clearance based on substantial equivalence, detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies are typically not required in the same way they would be for a Premarket Approval (PMA) application or a clinical trial for a novel device. The FDA essentially determined that because this device is substantially equivalent to legally marketed devices, it can be presumed to be as safe and effective as those predicate devices.

Summary

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NOV 2 3 1998

510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo 5.0mm Cannulated Screw System

K983006

Submission Information

Name and Address of the Sponsor of the 510(k) Submission:	Osteonics Corporation59 Route 17Allendale, NJ 07401-1677201-825-4900
Contact Person:	Kate SuttonRegulatory Affairs Specialist
Date Summary Prepared:	August 26, 1998
Device Identification
Proprietary Name:	Osteo 5.0mm CannulatedScrew System
Common Name:	Cannulated Screw
Classification Name and Reference:	Smooth or Threaded Metallic Bone FixationFastener21 CFR §888.3040

Predicate Device Identification

The subject components of the Osteo 5.0mm Cannulated Screw System are substantially equivalent to the components of the Synthes Titanium 4.5mm Cannulated Screw and the 4.5mm & 5.0mm cannulated screws in the ACE Medical Titanium Cannulated Screw and Reconstruction Plate System.

Device Description

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Intended Use

The Osteo 5.0mm Cannulated Screw System is indicated for ligament fixation and long and small bone fracture fixation, which may include the following:

Fixation of intermediate-sized fragments in fractures such as: .
- proximal and distal humerus fractures
- fractures of the olecranon process
- femoral fractures
- tibial plateau and metaphyseal fractures of the proximal and distal tibia
- medial and lateral malleolar and pilon fractures
- os calcis, talar, and patellar fractures -
. Ligament fixation of the proximal humerus
. Fractures of the pelvis and acetabulum
. Arthrodesis of the tarsals

Statement of Technological Comparison

The subject components of the Osteo 5.0mm Cannulated Screw Systems are substantially equivalent in design and intended use to the predicate devices offered by Synthes and ACE Medical.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird. The text is in all capital letters and is evenly spaced around the circle.

NOV 23 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K983006 Re: Osteonics 5.0mm Cannulated Screw System Trade Name: Requlatory Class: II Product Code: HWC Dated: August 26, 1998 August 28, 1998 Received:

Dear Ms. Staub:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. A 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. Please note: concerning your device in the Federal Register. 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 - Ms. Elizabeth A. Staub

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one Begandling Storen" (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 (800) 638-2041 or (301) 443-6597 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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510(k) Number (if known): K96 3006

Device Name: Osteo 5.0mm Cannulated Screw Systems

Indications For Use:

The Osteo 5.0mm Cannulated Screw Systems are indicated for ligament fixation and long and small bone fracture fixation, which may include the following:

For @5.0mm Cannulated Screws:

. Fixation of intermediate-sized fragments in fractures such as:
- proximal and distal humerus fractures -
- fractures of the olecranon process -
- femoral fractures -
- tibial plateau and metaphyseal fractures of the proximal and distal tibia a
- medial and lateral malleolar and pilon fractures -
- os calcis, talar, and patellar fractures -
Ligament fixation of the proximal humerus .
. Fractures of the pelvis and acetabulum
. Arthrodesis of the tarsals

. — — — — — —

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K983006

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.