K Number

Validate with FDA (Live)

Device Name

Biomet Variable Pitch Compression Screw System

Manufacturer

Biomet Inc

Date Cleared

2016-03-09

(57 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K092670

Predicate For

N/A

Intended Use

The Variable Pitch Compression Screw System is indicated for alignment and stabilization of small bone fractures. Specifically:

· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand fractures, non-unions, or mal-unions

Ligament reconstruction
· Osteochondritis dissecans
· Arthrodesis of the foot, ankle, wrist, elbow and hand

· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies,

and carpal/metacarpal osteotomies.

These procedures may be indicated as part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Device Description

The Biomet Variable Pitch Compression Screw System offers headless, cannulated compression screws in three different diameters in various lengths. The screws are manufactured from Titanium Alloy (ASTM F136) and are either color anodized or passivated for ease of size identification. The system will also include instrumentation to aid the user in alignment and stabilization of fractures to the skeletal system.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Biomet Variable Pitch Compression Screw System. This specific document describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.

Crucially, this document does not outline acceptance criteria for the device's performance in a diagnostic or analytical context, nor does it describe a study to prove the device meets such criteria in terms of accuracy, sensitivity, or specificity. This is because the device is a bone fixation fastener, not a diagnostic tool or an AI/ML-driven medical device. The "performance" being assessed here is primarily mechanical and material, establishing its safety and effectiveness for its intended surgical purpose.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points based on the information provided in the document.

Acceptance Criteria and Study Details (Based on Provided Document)

Since this is a 510(k) for a physical medical implant (a screw system), the "acceptance criteria" and "study" are focused on demonstrating mechanical and material equivalence to a legally marketed predicate device, rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML devices (e.g., specific thresholds for accuracy, sensitivity). Instead, the acceptance is based on demonstrating that the subject device's mechanical properties are comparable to or better than those of the predicate device, showing it is "substantially equivalent" and "will perform within the intended uses."

Characteristic/Test	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Tests	Sustain loads and forces comparable to predicate device per ASTM F543.	"Results indicate that the subject system is substantially equivalent to legally marketed devices." (Implies meeting or exceeding predicate performance in mechanical tests).
Intended Use	Same as predicate device (K092670).	"The Intended Use of the Biomet Variable Pitch Compression Screw System is the same as the intended uses cleared in the predicate BioDrive Micro Screws, K092670."
Indications for Use	Same as predicate device.	"The Indications for Use of the Biomet Variable Pitch Compression Screw System are the same as the predicate device."
Materials	Biocompatible, specific material (Titanium Alloy ASTM F136).	"Manufactured from Titanium Alloy (Ti-6Al-4V ELI ASTM F136)"; similar to predicate device's Titanium alloy.
Design Features	Similar to predicate, no safety/effectiveness impact from differences.	"Similar to currently marketed devices cleared in K092760 including the size (diameter), length, cannulation, and pitch." "Design differences have not identified any issues that would impact the safety and effectiveness."
Sterilization	Terminal sterilization methods (Gamma Irradiation for sterile, Steam for non-sterile) applicable and effective as predicate.	"Same as the predicate devices currently marketed and cleared via K092670."

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

Sample Size for Test Set: Not specified in terms of number of screws or test runs for the mechanical testing. "Non-clinical performance testing included mechanical testing to ASTM F543." This standard specifies how to perform the tests, but the specific number of units tested is not detailed in this summary.
Data Provenance: The mechanical testing was likely conducted in a laboratory setting by the manufacturer or a contracted testing facility. No country of origin for specific test data is provided, but the manufacturer is Biomet Inc. based in Warsaw, Indiana, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

Not applicable. For a mechanical device, ground truth is established by objective physical measurements and adherence to engineering standards (e.g., ASTM F543), not by expert consensus on, for example, image interpretation.

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

Not applicable. Adjudication methods are typically for subjective assessments, like medical image interpretation. Mechanical testing results are objective measurements.

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 surgical implant, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and "human readers improving with AI" are irrelevant.

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

Not applicable. This device is a physical product, not an algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" for mechanical testing is defined by established engineering principles and the specified test methods within ASTM F543, aiming to objectively demonstrate material strength, fatigue resistance, and overall structural integrity under simulated physiological conditions.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of mechanical device.

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary of 510(k) Conclusion:

The FDA's review and the manufacturer's submission for the Biomet Variable Pitch Compression Screw System focused on demonstrating substantial equivalence to an already legally marketed predicate device (EBI, LLC BioDrive Micro - K092670). This was achieved by showing that the new device has:

The same intended use and indications for use.
Similar technological characteristics (materials, design features, sterilization methods).
Non-clinical performance data (mechanical testing to ASTM F543) indicating that any differences in design or materials do not raise new questions of safety or effectiveness and that the device performs equivalently for its intended purpose.

No clinical studies were required or provided for this 510(k) given the established predicate and the nature of the device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.

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

March 9, 2016

Biomet Incorporated Ms. Julie Largent Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46582

Re: K160058

Trade/Device Name: Biomet Variable Pitch Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 11, 2016 Received: January 12, 2016

Dear Ms. Largent:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160058

Device Name

Variable Pitch Compression Screw System

Indications for Use (Describe)

The Variable Pitch Compression Screw System is indicated for alignment and stabilization of small bone fractures. Specifically:

· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand fractures, non-unions, or mal-unions

Ligament reconstruction
· Osteochondritis dissecans
· Arthrodesis of the foot, ankle, wrist, elbow and hand

· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies,

and carpal/metacarpal osteotomies.

These procedures may be indicated as part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Variable Pitch Compression Screw System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Julie LargentRegulatory Affairs Specialist305-269-6391
Date:	March 3, 2016
Subject Device:	Trade Name: Biomet Variable Pitch Compression Screw SystemCommon Name: Screw, Fixation, BoneClassification Name:

HWC Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)

Legally marketed devices to which substantial equivalence is claimed:

EBI, LLC+ BioDrive Micro - K092670

Device Description

Intended Use and Indications for Use

The Variable Pitch Compression Screw System is indicated for alignment and stabilization of small bone fractures.

Specifically:

. Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions
Ligament reconstruction
Osteochondritis dissecans
Arthrodesis of the foot, ankle, wrist, elbow and hand

- K092670 is officially registered under EBI, LLC D/B/A Biomet Trauma

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Image /page/4/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The word is presented in a straightforward, unadorned manner, with no additional design elements or background distractions.

. Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies.
These procedures may be indicated as part of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

. Intended Use: The Intended Use of the Biomet Variable Pitch Compression Screw System is the same as the intended uses cleared in the predicate BioDrive Micro Screws, K092670.
Indications for Use: The Indications for Use of the Biomet Variable Pitch Compression Screw System are the same as the predicate device.
. Materials: The Biomet Variable Pitch Compression Screw System screws are manufactured from Titanium Alloy (Ti-6Al-4V ELI ASTM F136) and the predicate screws are similarly manufactured from a Titanium alloy. The screws are either passivated or color anodized for ease of identification.
Design Features: The design features for the Biomet Variable Pitch Compression Screw System are similar to currently marketed devices cleared in K092760 including the size (diameter), length, cannulation, and pitch. The design differences have not identified any issues that would impact the safety and effectiveness of the devices.
. Sterilization: The implants are offered to the user either in the sterile or non-sterile configuration. The non-sterile devices will be required to be steam sterilized by the user prior to use while the sterile implants will be terminally sterilized by gamma irradiation. These sterilization configurations are the same as the predicate devices currently marketed and cleared via K092670.

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests
- Non-clinical performance testing included mechanical testing to ASTM F543 to o determine substantial equivalence of the Biomet Variable Pitch Compression Screw System. Results indicate that the subject system is substantially equivalent to legally marketed devices.
Clinical Tests
- No clinical tests are provided for basis of substantial equivalence. o

Substantial Equivalence Conclusion

The Biomet Variable Pitch Compression Screw System has shown to be substantially equivalent to the predicate device. Results of non-clinical tests and the similarities with legally marketed predicate devices indicate the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.

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.