The BioSymMetRic Proximal Interphalangeal Joint Fixator is an external fixator to assist in the healing of fractures or other bone cutting procedures of the fingers. The device is an external frame to provide stability and distraction for pins inserted through the skin into the bone.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the BioSymMetRic™ Proximal Interphalangeal Joint Fixator. It details the device's classification, intended use, risks, and substantial equivalence to a predicate device.

However, the document does not contain the information requested regarding:

Acceptance criteria and reported device performance: There is no table or discussion of specific performance metrics or thresholds the device must meet, nor any data demonstrating it has met them. The document is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.
Study design details: There is no mention of a formal study, test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set details. This type of information would typically be found in a clinical trial report or a detailed validation study, which is not present in this 510(k) summary.

Therefore, I cannot provide the requested table and study details. The document's purpose is to establish substantial equivalence to a previously cleared device, not to present a de novo performance study.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font.

APR 1 4 1998

980390

Summary of Safety and Effectiveness

Proprietary Name: BioSymMetRic™ Proximal Interphalangeal Joint Fixator

Classification Name and Product Code: Similar devices are classified in many The following classifications have been used for different categories. similar products:

Smooth or threaded metallic bone fixation fastener (888.3040), 87JDW or 87HTY
Appliance, fixationnail/blade/plate combination, multiple component (888.3030), 87KTT

Device Classification: Class II

Intended Use:

1. Complex fracture-dislocations of the proximal Interphalangeal joint.
1. Unstable PIP dislocations
1. Post-traumatic contracture of the PIP joint

Device Description: The BioSymMetRic Proximal Interphalangeal Joint Fixator is an external fixator to assist in the healing of fractures or other bone cutting procedures of the fingers. The device is an external frame to provide stability and distraction for pins inserted through the skin into the bone.

Potential Risks: The potential risks associated with this device include but are not limited to:

Infection Hematoma Pin loosening Nerve Damage Blood vessel damage Deformity of the joint Fracture of device Metal sensitivity

Bone Fracture Soft tissue imbalance Excessive Wear Disassociation of the components

Substantial Equivalent Device: Compass® Proximal Interphalangeal (PIP) Hinge from Smith & Nephew Richards cleared through 510(k) K970713.

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

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

OFFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

APR 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres ·Director, Requlatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

K980370 Re: BioSymMetRic™ Proximal Interphalangeal Joint Fixator Regulatory Class: II Product Code: KTT January 27, 1998 Dated: January 30, 1998 Received:

Dear Ms. Beres:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in your cial equivalence of your device to a legally rinaing or eabsours device results in a classification for your markets produced or mits 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Stephen Rhodes

elia 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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510(k) Number (if known):

Device Name: BioSymMetRic™ Proximal Interphalangeal Joint Fixator

Indications For Use:

1. Complex fracture-dislocations of the proximal Interphalangeal joint.
1. Unstable PIP dislocations
1. Post-traumatic contracture of the PIP joint

(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) X

Over-The-Counter Use_

Stathm Plurdes

(Optional Format 1-2-96)

(Division Sign Division of General Restorativ 510(k) Number

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.