SELF-COUNTERSINKING BONE SCREW by BIOMET ORTHOPEDICS, INC.

Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna as well as fractures in the patella
Fixation of 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 Self-Countersinking Bone Screw is a titanium screw that has cutting flutes in its head that allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a guide wire. The threads are self-drilling and self-tapping.

The screw will be available with diameters of 2.7mm and 4.3mm. The 2.7mm screws will have lengths from 8mm to 16mm (in 1mm increments) and 18mm to 36mm (in 2mm increments). All lengths of the 2.7mm screw are available fully threaded, with a short partial thread of 1/3 screw length and with a long partial thread of 1/2 screw length. The 2.7mm screw has a cannulation that will accept a 1.1mm guide wire.

The 4.3mm screw will have lengths from 10mm to 36mm (in 2mm increments) available fully threaded, with a short partial thread of 1/3 screw length and with a long partial thread of 1/2 screw length. The 4.3mm screw is also available in lengths of 38mm to 50mm (in 2mm increments) and 55mm to 65mm (in 5mm increments) and will be offered fully threaded, with a short partial 16mm thread and a long partial 32mm thread. The 4.3mm screw has a cannulation that will accept a 1.6mm guide wire.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Self-Countersinking Bone Screw." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials and specific performance metrics with acceptance criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving the device meets those criteria, or details about ground truth, expert adjudication, or MRMC studies.

Here's why and what information can be extracted:

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

Not Applicable. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Instead, mechanical testing was performed to establish substantial equivalence. No specific acceptance criteria or performance metrics in the way you've defined them (e.g., sensitivity, specificity, accuracy) are reported for the device as a standalone product.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. Since no clinical testing was performed for substantial equivalence, there is no test set or associated data provenance. Mechanical testing was performed, but details about sample sizes or specific data from these tests are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. No clinical test set or ground truth derived from experts was used for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. 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:

Not Applicable. This device is a bone screw, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

Not Applicable. This is a mechanical bone screw, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not Applicable. For mechanical testing, the "ground truth" would be engineering specifications and measurement results. However, details of these are not provided in this summary. For biological or clinical outcomes, no such data was used for this 510(k) summary.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of an AI/diagnostic device for this product.

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

Not Applicable. There is no "training set" or corresponding ground truth for this product.

Summary of what the document does state regarding demonstrating equivalence:

Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence to the predicate devices."
Clinical Testing: "Clinical testing was not used to establish substantial equivalence to predicate devices."
Summary of Technologies: "The Self-Countersinking Bone Screw's technological characteristics (materials, design, sizes, and indications) are similar to or identical to the predicate devices."

The entire submission is based on demonstrating that the Self-Countersinking Bone Screw is "substantially equivalent" to existing, legally marketed predicate devices (Synthes 3.0mm/3.5mm/4.0mm Cannulated Screws, DePuy-Ace 4.0mm Cannulated Cancellous Screw, Alphatec 2.7mm/3.5mm/4.0mm Cortical Lag Screws) in terms of its indications for use, technological characteristics (materials, design, sizes), and performance demonstrated through non-clinical (mechanical) testing. The FDA letter confirms that a substantial equivalence determination was made based on this information.

Summary

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DEC 1 7 2001

K013534
page 1 of 2

SUMMMARY OF SAFETY AND EFFECTIVENESS

ARTERS

Applicant or Sponsor:	Biomet Orthopedics, Inc.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Sara B. Shultz

CORPORAT

Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: (219) 267-6639 FAX: (219) 372-1683

Proprietary Name: Self-Countersinking Bone Screw

Common or Usual Name: bone screw

Screw, Fixation, Bone (888.3040) Classification Name:

Device Product Code: 87HWC

Substantially Equivalent Devices: Synthes 3.0mm Cannulated Screw and Threaded Washer. K962823, Synthes (USA), Synthes 3.5mm and 4.0mm Cannulated Screws, K963192, Synthes (USA), DePuy-Ace 4.0mm Cannulated Cancellous Screw, 510(k) unknown, Alphatec 2.7mm (K923256), 3.5mm (K922332), and 4.0mm (510(k) unknown) Cortical Lag Screw, Alphatec Mfg, Inc.

Indications for Use: The Self-Countersinking Bone Screw 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 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

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

월

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

000114

()FFICE 214).267.6639

I·AX 219.267.8137

E-MAH. biomet@biomet.com

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K013534
page 1 of 2

w is a titanium screw that has Device Description: The Selfcutting flutes in its head that allows it to cut into the bone, thus countersinking itself. The screw is also cannulated to allow insertion over a guide wire. The threads are self-drilling and self-tapping.

Summary of Technologies: The Self-Countersinking Bone Screw's technological characteristics (materials, design, sizes, and indications) are similar to or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.

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

000115

MAHING ADDRESS 120. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

()FFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@biome1.com

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Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2001

Ms. Sara B. Shultz Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K013534

Trade/Device Name: Self-Countersinking Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 22, 2001 Received: October 23, 2001

Dear Ms. Shultz:

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 (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.

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Page 2 - Ms. Sara B. Shultz

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manusing your manusan your device of your device to a legally premarket notincation. The PDF micing sification 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 and IT you desire spoolite ad roo for you in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 597-1007 Friends Compliance at (301) 594-4639. Also, please note the your deviced, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I cellulion circles, "Mioorening on your responsibilities under the Act may be obtained from the Oincl general mionnation on Jour sep-stional 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 yours,

Odie M. Witter, Ph.D., M.D.

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 of

K013534 510(k) NUMBER (IF KNOWN):

DEVICE NAME: Self-Countersinking Bone Screw

INDICATIONS FOR USE:

The Self-Countersinking Bone Screw is indicated for the fill of the filting the man

Fixation of fractures in long bones such as the fibula, tibia, humerus, 에 radius and ulna as well as fractures in the patella
Fixation of small bones such as those in the foot, ankle, wrist, and 1 elbow
Ligament reconstruction 트
Arthrodesis of the foot, ankle, wrist, and elbow 트
Small bone osteotomies 이
이 Osteochondritis dissecans

Signature of Offeror

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K013534 510(k) Number _

(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)

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

000003

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.