The Titanium Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion). The process of tibiotalocalcaneal arthrodesis using an intramedullary nail usually involves an ankle arthrotomy, preparation of the joint surfaces, and then placement of the nail through a plantar incision. Screws are placed proximally into the tibia in a standard fashion and, after compression, the nail can be locked distally with screws into the calcaneus and the talus.

The indications for tibiotalocalcaneal arthrodesis include:

Avascular necrosis of the talus
Failed total ankle arthroplasty
Trauma (malunited tibial pilon fracture)
Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
Revision ankle arthrodesis
Neuroarthropathy
Rheumatoid arthritis
Osteoarthritis
Pseudoarthrosis

Device Description

Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These ankle arthrodesis nails have the same general intended use (arthrodesis, internal fixation of bone), warnings and precautions as those nails previously cleared in K982953. The standard arthrodesis nails are10, 11, and 12 mm in diameter in 15 mm and 18 cm lengths. Longer lengths will be made upon request (up to 46 cm length). The longer nails will be used to treat patients who may require revision of a previously implanted arthrodesis nail due to tibial fracture. Substantially similar titanium femoral and tibial nails in 8, 9, 10, 11, 12, 13 and 14 mm diameters up to 46 cm in length were previously cleared in K982953.

This device utilizes standard technology that is commonly known by physicians. This technology has been used in commercially available metallic internal fixation devices prior to May 28, 1976. This particular device is a tubular metal rod that is inserted through the talus and into the medullary canal of the tibia to stabilize bone fragments until healing has occurred.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Titanium Ankle Arthrodesis Nail). It establishes substantial equivalence to a predicate device and outlines the intended use and indications for use. However, it does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.

Medical devices like this intramedullary nail typically demonstrate "acceptance criteria" through various engineering and biocompatibility tests, and often through clinical literature references rather than a single, specific study detailed in a 510(k) summary. The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested fields cannot be directly answered from the provided document.

Here's an attempt to answer based on the available information and general knowledge of 510(k) submissions for similar devices, noting where information is explicitly not present:

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

Acceptance Criteria	Reported Device Performance
Not specified in this document. For this type of device (intramedullary nail), acceptance criteria would typically include: - Mechanical Properties: Tensile strength, yield strength, fatigue life, torsional strength (meeting ISO standards or equivalent for implantable metals). - Biocompatibility: Absence of cytotoxicity, sensitization, irritation, genotoxicity, etc., as per ISO 10993 standards. - Sterility: Demonstrated sterility assurance level (SAL). - Corrosion Resistance: Meeting standards for implantable titanium alloy. - Dimensional Accuracy: Conformance to design specifications.	The document states that the device is "substantially equivalent" to predicate devices (Biomet Titanium Intramedullary Nails previously cleared in K982953) and uses "standard technology that is commonly known by physicians." This implies that the device meets the performance and safety profiles of these predicate devices based on the inherent properties of titanium alloy and the established design of intramedullary nails. Specific quantitative performance data is not provided in this summary.

Acceptance Criteria

Reported Device Performance

Not specified in this document. For this type of device (intramedullary nail), acceptance criteria would typically include: - Mechanical Properties: Tensile strength, yield strength, fatigue life, torsional strength (meeting ISO standards or equivalent for implantable metals). - Biocompatibility: Absence of cytotoxicity, sensitization, irritation, genotoxicity, etc., as per ISO 10993 standards. - Sterility: Demonstrated sterility assurance level (SAL). - Corrosion Resistance: Meeting standards for implantable titanium alloy. - Dimensional Accuracy: Conformance to design specifications.

The document states that the device is "substantially equivalent" to predicate devices (Biomet Titanium Intramedullary Nails previously cleared in K982953) and uses "standard technology that is commonly known by physicians." This implies that the device meets the performance and safety profiles of these predicate devices based on the inherent properties of titanium alloy and the established design of intramedullary nails. Specific quantitative performance data is not provided in this summary.

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

Sample Size: Not applicable/not provided. This document does not describe a clinical performance study with a distinct "test set" of patients. The substantial equivalence relies on comparison to a predicate device and the known properties of the materials and design.
Data Provenance: Not applicable/not provided.

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

Not applicable/not provided. No clinical "test set" requiring ground truth establishment is described.

4. Adjudication method for the test set

Not applicable/not provided.

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 (orthopedic nail), not an AI-powered diagnostic or assistive tool. MRMC studies are for evaluating diagnostic image interpretation by human readers, often with and without AI assistance.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "truth" here is established primarily through engineering testing against recognized standards for medical implants and clinical history of similar predicate devices. Outcomes data for a general class of devices (intramedullary nails) in orthopedic surgery would support their effectiveness, but a specific "ground truth" for this device in a study is not mentioned.

8. The sample size for the training set

Not applicable/not provided. A "training set" is relevant for machine learning algorithms, which this device is not.

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

Not applicable/not provided.

Summary

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AUG 26 2002

K021786 p1/2

Summary of Safety and Effectiveness Titanium Ankle Arthrodesis Nail

Applicant/Sponsor: Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person: Lonnie Witham Telephone: (574) 267-6639 Fax: (574) 372-1683
Proprietary Name: Titanium Ankle Arthrodesis Nail

Common Name: Titanium Intramedullary Nail (Rod)

Classification Name: Intramedullary Rods (21 CFR 888.3020)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed: These devices are substantially equivalent to Biomet Titanium Intramedullary Nails previously cleared in K982953.

Device Description: Intramedullary rods made of titanium alloy are used for the same indications as stainless steel intramedullary rods that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Transverse screws can be used to further stabilize bone fragments distally and proximally, as needed. A wide variety of titanium intramedullary nails indicated for used in long bones (femur, tibia, fibula, humerus, radius, and ulna were cleared for commercial distribution in Biomet 510(k) premarket notification (K982953).
These ankle arthrodesis nails have the same general intended use (arthrodesis, internal fixation of bone), warnings and precautions as those nails previously cleared in K982953. The standard arthrodesis nails are10, 11, and 12 mm in diameter in 15 mm and 18 cm lengths. Longer lengths will be made upon request (up to 46 cm length). The longer nails will be used to treat patients who may require revision of a previously implanted arthrodesis nail due to tibial fracture. Substantially similar titanium femoral and tibial nails in 8, 9, 10, 11, 12, 13 and 14 mm diameters up to 46 cm in length were previously cleared in K982953.

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Intended Use: The Titanium Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion). The process of tibiotalocalcaneal arthrodesis using an intramedullary nail usually involves an ankle arthrotomy, preparation of the joint surfaces, and then placement of the nail through a plantar incision. Screws are placed proximally into the tibia in a standard fashion and, after compression, the nail can be locked distally with screws into the calcaneus and the talus.

Indications for Use

The indications for tibiotalocalcaneal arthrodesis include:

1. Avascular necrosis of the talus
1. Failed total ankle arthroplasty
1. Trauma (malunited tibial pilon fracture)
1. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
1. Revision ankle arthrodesis
1. Neuroarthropathy
1. Rheumatoid arthritis
1. Osteoarthritis
1. Pseudoarthrosis

Summary of Technology: This device utilizes standard technology that is commonly known by physicians. This technology has been used in commercially available metallic internal fixation devices prior to May 28, 1976. This particular device is a tubular metal rod that is inserted through the talus and into the medullary canal of the tibia to stabilize bone fragments until healing has occurred.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

AUG 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lonnie Witham Biomet, Inc. P. O. Box 587 Warsaw. Indiana 46581- 0587

Re: K021786

Trade/Device Name: Titanium Ankle Arthrodesis Nail Regulatory Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: May 10, 2002 Received: May 30, 2002

Dear Mr. Witham:

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 - Mr. Lonnie Witham

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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AUG 2 6 2002

STATEMENT OF INDICATIONS FOR USE

510(k) Number_ (()L (78 (78 (1) ==============================================================================================================================================

Device Name: Titanium Ankle Arthrodesis Nail

Indications for Use

The indications for tibiotalocalcaneal arthrodesis include:

1. Avascular necrosis of the talus
1. Failed total ankle arthroplasty
1. Trauma (malunited tibial pilon fracture)
1. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
1. Revision ankle arthrodesis
1. Neuroarthropathy
1. Rheumatoid arthritis
1. Osteoarthritis
1. Pseudoarthrosis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR
(Per 21 CFR 801.109)

Signature

(Division Sign-Off)	00000
Division of General, Restorative

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

Neurological Devices
510(k) Number K021

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.