The Subtalar Implant is indicated for use in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, and medial displacement of the talus, thereby limiting the excessive eversion of the hindfoot. Examples include, but are not limited to:

Symptomatic acquired flat foot treatment in children and adolescents .
Symptomatic congenital flexible flat foot .
Tarsal coalitions when associated with the flatfoot deformity .
Posterior tibial tendon dysfunction with supple feet .
Paralytic flat foot .
Subtalar Instability .
Severely pronated foot .

Device Description

The Subtalar Implant is a one-piece device comprised of titanium alloy or PEEK-OPTIMA® intended to be implanted into the sinus tarsi of the implant is available in eight sizes to accommodate a wide range of patient sizes. The device is used to stabilize the subtalar joint by restoring the arch of the foot and block anterior movement of the talus.

AI/ML Overview

This 510(k) summary for the Biomet Subtalar Implant (K071498) primarily relies on non-clinical testing for substantial equivalence and does not include any clinical study data or acceptance criteria related to device performance in terms of diagnostic accuracy or clinical outcomes.

Here's an analysis based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated)	Reported Device Performance
Mechanical Needs of Subtalar Joint Function within Intended Use	Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use.

Explanation: The document explicitly states "Non-Clinical Testing: Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use." This is the only "acceptance criteria" and "performance" described. There are no detailed quantitative metrics provided for these mechanical tests (e.g., specific load endurance, fatigue limits, etc.) within this summary, suggesting these details were likely provided in a separate, more comprehensive test report that was part of the 510(k) submission but not included in this publicly available summary.

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

Sample Size: Not applicable/Not mentioned for any human diagnostic or clinical performance study. The "test set" refers to the mechanical tests conducted. The number of physical implants or test specimens used for mechanical testing is not specified in this summary.
Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated in a laboratory setting. No country of origin is specified for the mechanical testing.

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

Not applicable. There was no human "test set" requiring expert ground truth establishment for diagnostic or clinical performance. The "ground truth" for mechanical testing would be defined by engineering standards and specifications.

4. Adjudication Method for the Test Set

Not applicable. No human interpretation or adjudication was involved in the mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study was conducted or provided for human reader improvement with AI assistance.

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

No. This device is a physical implant, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the mechanical testing: Engineering specifications and standards. The "ground truth" for mechanical performance is determined by whether the device's physical properties withstand specified forces, fatigue cycles, etc., as per relevant industry or regulatory standards for bone fixation devices.
For clinical efficacy/safety: Not applicable. No clinical ground truth was established or provided in this submission for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, no training set was used.

Summary of the K071498 Submission's Approach:

The K071498 submission for the Biomet Subtalar Implant relied on demonstrating substantial equivalence to previously legally marketed predicate devices through:

Comparison of technological characteristics: Materials (titanium alloy or PEEK-OPTIMA®), design, sizing, and indications were stated to be similar or identical to predicates.
Non-clinical mechanical testing: To ensure the device's physical integrity and functionality.
Absence of clinical data: The submission did not provide clinical testing data, meaning substantial equivalence was established without a direct clinical comparison of outcomes. This is common for many Class II devices and 510(k) submissions where predicates exist and the technological changes are considered minor or well-understood in terms of clinical impact.

Summary

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K071498

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JUL 3 1 2007

Image /page/0/Picture/3 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in a bold, sans-serif font, with the letters connected. Below the word "BIOMET" is the text "ORTHOPEDICS, INC." in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

510(k) Summary Subtalar Implant

May 30, 2007 Preparation Date: Applicant / Sponsor: Biomet Sports Medicine Elizabeth Wray Contact Person: Proprietary Name: Subtalar Implant Bone fixation device Common Name: Classification Name: Class II

HWC- Smooth or threaded metallic bone fixation fastener (888.3040) .

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Subtalar MBA® Implant System- K960692, 07/23/1996, Kinetikos Medical Incorporated (KMI) Subtalar Arthrorisis Implant (Conical Subtalar Implant or CST) K032902, 12/15/2003, Nexa Orthopedics- Previously Futura Biomedical Kalix Implant- K001231, 07/11/2000, New Deal- An Integra LifeSciences Company

Device Description:

Indications for Use/Intended Use:

Examples include, but are not limited to:

Symptomatic acquired flat foot treatment in children and adolescents .
. Symptomatic congenital flexible flat foot
Tarsal coalitions when associated with the flatfoot deformity .
. Posterior tibial tendon dysfunction with supple feet
Paralytic flat foot .
Subtalar Instability .
Severely pronated foot .

Summary of Technologies:

The technological characteristics (materials, design, sizing, and indications) of the Subtalar Implant are similar or identical to the predicate device or other previously cleared devices.

Non-Clinical Testing: Mechanical testing confirmed that the Subtalar Implant meets the mechanical needs of the subtalar joint and will function within its intended use.

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Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc, except Subtalar MBA®, PEEK-OPTIMA®, and Kalix(B).

Mailing Address: Shipping Address: P.O. Box 587 56 East Bell Drive Warsaw IN 46581-0587 Warsaw, IN 46582 Toll Free: 800 348 9500 Office: 574.267 6639 Main Fax: 574.267.8137 www.biomet.com

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or waves, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Sports Medicine, Inc. % Ms. Elizabeth Wray Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

JUL 3 1 2007

Re: K071498

Trade/Device Name: Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 30, 2007 Received: May 31, 2007

Dear Ms. Wray:

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. Elizabeth Wray

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Muchin
tor

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K071498

Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Symptomatic acquired flat foot treatment in children and adolescents .
Symptomatic congenital flexible flat foot .
Tarsal coalitions when associated with the flatfoot deformity .
Posterior tibial tendon dysfunction with supple feet .
Paralytic flat foot .
Subtalar Instability .
Severely pronated foot .

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buckner
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number K071498

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.