Bone plates and screws from the Smith and Nephew Bone Plate System are 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, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

Device Description

The subject of this Traditional 510(k) premarket notification is to expand the indications of the already existing, cleared Smith & Nephew Cannulated Screws and Washers by adding osteotomies and arthrodesis. The subject devices are part of the Smith and Nephew Bone Plate System cleared under 510(k) number K993106 and K060736 with the same original indications but the subject 4.0mm, 5.5mm, 6.5mm, 7.0mm and 8.0mm cannulated screws and associated washers have additional indications independent of the Bone Plate System.

The screws vary in diameter, length and thread length; have fluted screw tips for self-tapping and self-drilling and have a hexagonal screw heads. The screws may be used with bone washers to extend the surface area of the head if needed. These screws are cannulated to allow the screws to be accurately positioned with the use of a guidewire instrument. The device offering consist of diameters of 4.0mm, 5.5mm, 7.0mm and 8.0mm in titlanium allov and stainless steel.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Smith & Nephew Cannulated Screws and Washers), not an AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable to this document.

However, I can extract information related to the device's functional performance and how its safety and effectiveness were demonstrated through bench testing and comparison to predicate devices.

Here's a summary of the information relevant to the device's acceptance criteria and the study that demonstrates it meets those criteria, rephrased to align with the spirit of your request where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric/Criteria	Acceptance Criteria	Reported Device Performance
Mechanical Performance: Three-point bend fatigue	"Capable of withstanding expected in vivo loading without failure" (relative to predicates)	4.0mm Screws (Ti and SS): Performed "equal or better" than the S&N 3.0mm SS screw (predicate).5.5mm Screws (Ti and SS): Performed "equal or better" than the Synthes titanium 4.5mm screw (predicate).
Mechanical Performance: Static torsional	"Capable of withstanding expected in vivo loading without failure" (relative to predicates)	4.0mm Screws (Ti and SS): Performed "equal or better" than the S&N 3.0mm SS screw (predicate).5.5mm Screws (Ti and SS): Performed "equal or better" than the Synthes titanium 4.5mm screw (predicate).
Mechanical Performance: Axial pullout bend test	"Capable of withstanding expected in vivo loading without failure" (relative to predicates)	4.0mm Screws (Ti and SS): Performed "equal or better" than the S&N 3.0mm SS screw (predicate).5.5mm Screws (Ti and SS): Performed "equal or better" than the Synthes titanium 4.5mm screw (predicate).
Biocompatibility/Material Safety (Chemical Composition):	Mechanical properties of Ti 6 Aluminum-7 Niobium should be similar to Ti 6 Aluminum-4 Vanadium (if substituting)	Bench testing showed the subject screws (possibly using Ti 6 Aluminum-7 Niobium, if this was the material in question as compared to the predicate's Ti 6 Aluminum-4 Vanadium) performed "equal or better" than the predicate screw made with the original material. The manufacturer of the raw material stated the mechanical properties are "almost identical" and it's a "common alloy used in orthopedic implants." This demonstrates the difference does not affect safety and effectiveness.
Substantial Equivalence: Indications for Use	Similar to predicate devices.	The subject device shares "very similar indications for use and intended use" with predicate devices. The expanded indications (osteotomies and arthrodesis) are consistent with existing predicate devices.
Substantial Equivalence: Design features	Similar to predicate devices.	"Similar in dimensions (screw diameter, screw length)," cannulated, varying thread lengths, offered with accessory bone screw washers. (Minor differences in screw head dimensions and thread length were deemed not to affect safety/effectiveness).
Substantial Equivalence: Operational principles	Similar to predicate devices.	Implied similarity is based on the devices being "cannulated screws and washers" for bone fixation.
Substantial Equivalence: Material composition	Similar to predicate devices.	Both offered in Stainless Steel (SS) and Titanium (Ti) Alloy. (Minor difference in specific Ti alloy composition for one predicate was addressed).

Study Details:

Since this is a submission for a traditional medical device (cannulated screws and washers), the "study" demonstrating performance is primarily bench testing and comparison to predicate devices to establish substantial equivalence.

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

Test Set Sample Size: Not explicitly stated as a numerical sample size in terms of "cases" or "patients" as would be for an AI/ML study. Instead, the "test set" consists of physical samples of the Smith & Nephew Cannulated Screws (4.0mm and 5.5mm in both Ti and SS) used for mechanical bench testing.
Data Provenance: The mechanical testing was conducted by Smith & Nephew, Inc. at their facilities, using their manufactured devices and predicate devices. No patient or human data is involved in this type of testing for substantial equivalence.

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

Not Applicable. For a traditional mechanical device, the "ground truth" for performance is established through objective physical measurements and engineering standards in bench testing. There are no "experts" establishing ground truth in the context of interpreting medical images or diagnoses. The interpretation of test results would be done by qualified engineers.

4. Adjudication Method for the Test Set

Not Applicable. Mechanical bench testing results are quantitative and objective. There is no subjective interpretation requiring adjudication among multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device, so an MRMC study is not relevant or performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Bench Test Results / Engineering Standards: The "ground truth" for showing the device meets its performance criteria is based on direct measurements of mechanical properties (fatigue, torsion, pullout strength) against established engineering standards and comparisons to the performance of legally marketed predicate devices. The goal is to demonstrate that the new device performs "equal or better" than existing similar devices, suggesting it is safe and effective for its intended use.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device; there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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K111994 # '1/4

OCT

1572

510(k) Summary of Safety and Effectiveness Smith & Nephew Cannulated Screws and Washers

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 6, 2011
Contact Person:	Maureen Whitson, Senior Regulatory Affairs SpecialistTel: 901-399-6845, Fax 901-566-7568
Proprietary Name:	Smith & Nephew Cannulated Screws and Washers
Common Name:	Cannulated Screws and Washers
Device Classification Name andReference:	21 CFR 888.3040 Smooth or threaded metallic bonefixation fastenerand21 CFR 888.3030 Single/multiple componentmetallic bone fixation appliances and accessories
Device Class:	Class II
Panel Code:	Orthopedics/ 87 - HWC and NDG

Device Description

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KI111994 # 2/4

Diameter	Length Range	Thread Length Range	Material
4mm	20mm - 70mm	8mm - 15mm	Ti
4mm	10mm - 70mm	5mm - 15mm and fully threaded	SS
5.5mm	20mm - 120mm	8mm - 32mm and fully threaded	Ti
5.5mm	20mm - 120mm	5mm - 15mm and fully threaded	SS
6.5mm	30mm - 180mm	22mm - 46mm and fully threaded	Ti
6.5mm	30mm - 150mm	22mm - 46mm and fully threaded	SS
7mm	30mm - 150mm	16mm - 32mm and fully threaded	Ti
7mm	30mm - 150mm	16mm - 32mm and fully threaded	SS
8mm	40mm - 180mm	22mm - 46mm and fully threaded	Ti
8mm	40mm - 180mm	22mm - 180mm and fully threaded	SS

Smith & Nephew Cannulated Screw Size Ranges

Summary of Cannulated Screw Accessory Washers

AccessoryDevice	Type	Size Range	Material
Washers	Round	4.0mm to 8.0mm Internal Diameter	Ti and SS
Washer	Butterfly	8.0mm Internal Diameter and OverallLength 21.7mm	Ti and SS

Intended Use

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K111994 #3/4

Technological Characteristics

The Smith & Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021932, K052483, and K003496. When compared to the predicates, the devices share very similar indications for use and intended use, are manufactured from similar materials and incorporate similar technical design characteristics.

A review of the mechanical data indicates that the Smith & Nephew Cannulated Screws are capable of withstanding expected in vivo loading without failure. The performance bench testing consisted of a three point bend fatigue, static torsional and axial pullout bend test, comparing the S&N 4.0mm screws (Ti and SS) to the S&N 3.0mm SS screw and the results show the subject screw would perform equal or better that the predicate screws. The performance bench testing also consisted of a four point bend fatigue, static torsional and axial pullout bend test, comparing the S&N 5.5mm screws (Ti and SS) to the Synthes titanium 4.5mm screw and the results show the subject screws would perform equal or better than the predicate screws.

Substantial Equivalence Information:

The substantial equivalence of the Smith & Nephew Cannulated Screws and Washers is based on its similarities in indications for use, design features, operational principles, and material composition to the devices listed below.

Manufacturer	Description	SubmissionNumber
Smith & Nephew	Smith & Nephew 3.0 Cannulated Screw, SS	K090675
Synthes	4.5 Headless Compression Screw (cannulated), Ti	K080943
Osteomed	Osteomed Headless Cannulated Screw System	K063298
Pioneer	Pioneer Cannulated Screw System	K102903
Synthes	Synthes 6.5 mm Cannulated Screw	K021932
Synthes	Synthes Spherical Washers	K052483
Pioneer	Cannulated Screw System, Washer	K003496

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K 11119944444

Similarities and Difference between the Subject Devices and predicate Devices

Similarities

	Similarities of Subjects to Predicates
Design	Similar in dimensions (screw diameter, screw length )
Features	Both predicate and subject are cannulated, both havevarying thread lengths, both are offered with accessory bonescrew washers
Material	Both are offered in SS and Ti Alloy
Indications for Use	Both are indicated for fractures, osteotomies and arthrodesisof various small bones and joints

Differences

	Differences of Subjects toPredicates	Rationale why this difference does not affectthe Safety and Effectiveness
Design	Screw head dimensions mayhave slight size differencesand some may be smoothand others may be threadedor "headless"	Headless screws are used for counter-sinking to prevent the implanted screw fromsitting too proud on the bone surface and arefor surgeon preference. The screw head sizedoes not affect the performance of theimplanted screw in regard to the mechanicalstresses on the shaft of the screws.
Design	Varying screw thread length	The thread lengths do not affect themechanical stresses of the implanted screws.Their application is chosen based on surgeonpreference and on what kind of fracture,osteotomy or arthrodesis in which the screwwill be used.
ChemicalComposition	The predicate Synthes4.5mm Ti alloy screw is madefrom Ti -6Aluminum -7Niobium instead of Ti 6Aluminum- 4Vanadium	The niobium was substituted for thevanadium as the beta stabilizing element inthis alloy. According to the manufacturer ofthe raw material, the mechanical propertiesare almost identical and it is a common alloyused in orthopedic implants. Our benchtesting shows the subject screws performedequal or better than the predicate screwmade with this material

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Ms. Maureen Whitson Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova. Tennessee 38106

OCT 1 1 2011

Re: K111994

Trade/Device Name: Cannulated Screws and Washers Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. NDG Dated: July 12, 2011 Received: July 13, 2011

Dear Ms. Whitson:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Ms. Maureen Whitson

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Pon Nth

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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): ____________________________________________________________________________________________________________________________________________________

Device Name:

Cannulated Screws and Washers

Indications for Use:

Bone plates and screws from the Smith and Nephew Bone Plate System are 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, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones, treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

AND/OR

Prescription Use

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

urrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number

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.