The Smith & Nephew Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional bone fixation.

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are for single use only.

Device Description

The subject devices are line additions to the Smith & Nephew Bone Plate System. These line additions are comprised of 6.5mm and 8.0mm diameter Cannulated Screws, which are self-tapping and self-drilling screws with a cancellous thread that can be guided into position through use of a guide-wire. These devices are available partially or fully threaded. Partially threaded Cannulated Screws are available in overall lengths ranging from 30mm - 180mm and with thread lengths of 16mm, 40mm and 47mm. Fully threaded Cannulated Screws are available in overall lengths ranging from 30mm - 180mm. Three washer configurations will also be made available as accessory items. Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are manufactured from stainless steel and titanium materials.

AI/ML Overview

This submission is for a traditional 510(k) for medical devices, specifically bone screws, not for an AI/ML powered device. Therefore, the detailed information requested about acceptance criteria, study methodologies for AI/ML performance, sample sizes, expert ground truth establishment, adjudication methods, and MRMC studies is not applicable.

The submission focuses on demonstrating "substantial equivalence" to predicate devices already on the market, based on similarities in indications for use, design features, operational principles, and material composition.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like these bone screws, "acceptance criteria" are generally related to their mechanical properties and biological compatibility, ensuring they can withstand normal physiological loads and are safe for implantation. Performance is demonstrated through similarity to existing devices and, implicitly, through mechanical testing.

Acceptance Criteria Category	Reported Device Performance (as implied by Substantial Equivalence)
Indications for Use	Identical to predicate devices (pelvic, small and long bone fracture fixation for adult and pediatric patients including specific bone fractures, hip arthrodesis, provisional bone fixation).
Design Features	6.5mm and 8.0mm diameter Cannulated Screws, self-tapping, self-drilling, cancellous thread, guided by guide-wire, available partially or fully threaded (30-180mm lengths), various thread lengths (16mm, 40mm, 47mm), three washer configurations. These are similar to predicate devices.
Operational Principles	Identical to predicate devices.
Material Composition	Manufactured from stainless steel and titanium materials, similar to predicate devices.
Mechanical Strength/Integrity	"A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure." (Specific numerical acceptance criteria for mechanical tests are not detailed in this summary document but would be part of the full submission.)
Biological Compatibility	Implied equivalent to predicate devices, which are already accepted for implantation in human body.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for a 510(k) submission showing substantial equivalence for mechanical devices. The "test set" would refer to mechanical testing of the screws themselves, not a dataset of patient information. The document states "test data" was reviewed, implying mechanical/bench testing, not clinical trials or data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth for mechanical device performance is established through engineering specifications, biomechanical principles, and standardized testing methods, not expert consensus on patient data.

4. Adjudication Method

Not applicable for this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is for AI/ML-powered diagnostic or assistive devices, not bone screws.

6. Standalone Performance Study

Not applicable. This concept pertains to AI/ML software.

7. Type of Ground Truth Used

For this device, the "ground truth" for demonstrating safety and effectiveness relies on:

Engineering Specifications and Bench Testing: Mechanical properties (e.g., torsion, bending, pull-out strength, fatigue life) are tested against established engineering standards and compared to the performance of predicate devices.
Material Standards: Conformance to industry standards for medical-grade stainless steel and titanium.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness profile of the already cleared predicate devices (K993106, K903810, K000080, and K051296).

8. Sample Size for the Training Set

Not applicable. There is no AI/ML training set for this device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI/ML training set.

Summary

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K060736

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116	Date: March 17, 2006
Contact Person:	David Henley, Senior Regulatory Affairs Specialist
Proprietary Name:	Smith & Nephew 6.5mm and 8.0mm Cannulated Screws
Common Name:	Bone Screw
Classification Name and Reference:	21 CFR 888.3040 – Smooth or threaded metallic bone fixationfastener, Class II
Device Product Code and Panel Code:	HWC / Orthopaedics / 87

Device Description:

Indications for Use:

Smith & Nephew Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation. Indications for use include fractures of the tibia, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional bone fixation.

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are for single use only.

Technological Characteristics:

The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information:

Substantial equivalence for Smith & Nephew 6.5mm and 8.0mm Cannulated Screws is based on its similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions:

K993106, Smith & Nephew Bone Plate System; K903810, Ace Medical Cannulated Screw; K000080, Howmedica Osteonics ASNIS III Cannulated Screw System; and K051296, DePuy Spine Inc. SIJF Cannulated Screw System.

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Image /page/1/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The graphic consists of three curved lines that appear to represent human profiles or faces in a row, with the lines becoming more wavy towards the bottom, possibly symbolizing movement or flow. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 8 2006

Smith & Nephew. Inc. Orthopacdic Division c/o Mr. David Henley Senior Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116

Re: K060736

Trade/Device Name: Smith & Nephew 6.5mm and 8.0mm Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 17, 2006 Received: March 20, 2006

Dear Mr. Henley:

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

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Page 2 - Mr. David Henley

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. 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 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.

Herbert Kramer

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

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): 1000736

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws Device Name:

Indications for Use:

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are for single use only.

Prescription Use X ============================================================================================================================================================================ and/or (Per 21 CFR 801, 109)

Over-the-Counter Use (Optional Format 1-2-96)

(Please DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hadi Lesner

Division of General, Restorative, and Neurological Devices

510(k) Number K060736

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.