PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM

• K Number: K024086
• Device Name: PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
• Manufacturer: BIOMET ORTHOPEDICS, INC.
• Date Cleared: 2003-01-09 ( 29 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K013534
• Predicate For: K081813 , K082874

Intended Use

The Propeller Head Small Cannulated Screw System is indicated for the following conditions:

• Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna . as well as fractures in the patella.
• Fixation of the small bones such as those in the foot, ankle, wrist and elbow. ●
• . Ligament reconstruction
• Arthrodesis of the foot, ankle, wrist and elbow. .
• Small bone osteotomies .
• Osteochondritis dissecans

Device Description

The Propeller Head Small Cannulated Screw System is a titanium screw that has cutting flutes in the head, which allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a quide wire. The threads are selfdrilling and self-tapping.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Propeller Head Small Cannulated Screw System." It explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence."

Therefore, the device's acceptance criteria were not based on clinical performance studies, but rather on non-clinical mechanical testing and comparison to a legally marketed predicate device.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from text)	Reported Device Performance (from text)
Performance as well as or better than previously marketed devices.	"Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices."

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable, as no clinical test set was used. Mechanical testing typically involves a set number of screws, but this specific number is not provided in the document.
• Data provenance: Not applicable for clinical data. For mechanical testing, the data would originate from laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as no human-reviewed test set or clinical ground truth was established.

4. Adjudication method for the test set

• Not applicable, as no clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a bone screw, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical bone screw and does not involve any algorithms or AI for standalone performance.

7. The type of ground truth used

• The "ground truth" for the device's performance was established through mechanical testing comparing the device against the performance of predicate devices. There was no clinical ground truth (e.g., pathology, outcomes data) used for this submission.

8. The sample size for the training set

• Not applicable, as no training set was used for an AI or machine learning model.

9. How the ground truth for the training set was established

• Not applicable, as no training set was used.

Summary

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BIOMET

K024086

Page 1 of 1

JAN 0 9 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Biomet Orthopedics, Inc56 E. Bell DriveP.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Kacy Arnold, RN, MBATelephone: [phone]Fax: [phone]
Proprietary Name:	Propeller Head Small Cannulated Screw System
Common or Usual Name:	Bone Screw
Device Classification:	Screw, Fixation, Bone (888.3040)
Device Product Code:	87HWC
Legally Marketed DevicesTo Which SubstantialEquivalence Is Claimed:	Self-Countersinking Bone Screw (K013534)

Indications for Use: The Propeller Head Small Cannulated Screw System is indicated for the following conditions:

• Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna . as well as fractures in the patella.
• Fixation of the small bones such as those in the foot, ankle, wrist and elbow. ●
• . Ligament reconstruction
• Arthrodesis of the foot, ankle, wrist and elbow. .
• Small bone osteotomies .

Device Description: The Propeller Head Small Cannulated Screw System is a titanium screw that has cutting flutes in the head, which allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a quide wire. The threads are selfdrilling and self-tapping.

Non-Clinical Testing: Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

.

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

()FFICE 574.267.6639 FAX [phone]

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E-MAH. [e-mail]

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2003

Kacy Arnold, RN, MBA Regulatory Affairs Specialist Biomet. Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K024086

Trade/Device Name: Propeller Head Small Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 9, 2002 Received: December 11, 2002

Dear Ms. Arnold:

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 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.

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Page 2 - Kacy Arnold, RN, MBA

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 [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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html .

Sincerely vours,

R. Mark N. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510 (k) Number (if known) : _ KO 2 4 08 6

Device Name: Propeller Head Small Cannulated Screw System

Indications for Use: The Propeller Head Small Cannulated Screw System is indicated for the following conditions:

• Fixation of fractures in long bones. .
• Fixation of the small bones, including those in the foot, patella, ankle, wrist and . elbow.
• Ligament reconstruction ●
• Arthrodesis of the foot, ankle, wrist and elbow. .
• Small bone osteotomies ●
• Osteochondritis dissecans

for Mink A. Millerson

of General. Restorative and Notice rical Devices

510(k) Number K024086

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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.