SMALL HAMMER TOE PIN

• K Number: K021828
• Device Name: SMALL HAMMER TOE PIN
• Manufacturer: BIOMET, INC.
• Date Cleared: 2002-07-01 ( 27 days)
• Product Code: HWC , 87H
• Regulation Number: 888.3040
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K011137
• Predicate For: K100414

Intended Use

The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.

Device Description

The Small Hammer Toe Pin is made out of the oriented Lactosorb® material and is indicated for proximal interphalangeal joint (PIP) joint arthrodesis. LactoSorb® is a polyester derivative of L-Lactic and glycolic acids. Poly Llactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into Llactic and glycolic acids, which are then metabolized by the body. The device has threads on one end and barbs on the other.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for a medical device (Small Hammer Toe Pin). It does not contain any information about acceptance criteria, device performance metrics, or the details of a study that would prove the device meets such criteria.

Instead, the document focuses on:

• Device identification: Proprietary name, common name, classification, product code, and predicate device.
• Intended Use: Proximal interphalangeal (PIP) joint arthrodesis.
• Device Description: Material (Lactosorb® - a resorbable polymer), and physical features (threads on one end, barbs on the other).
• Non-Clinical Testing: Mentions that non-clinical testing "demonstrated statistical equivalence between this device and the predicate." However, it does not provide any specific acceptance criteria or results of this testing.
• Clinical Testing: Explicitly states, "Clinical testing was not used to establish substantial equivalence." This means there's no clinical study described in this document to evaluate the device's performance against acceptance criteria.
• FDA determination: A letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device. This is a regulatory finding for market clearance, not an evaluation of performance against specific acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and study details because it is not present in the provided text.

Summary

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JUL 1 2002

K021828P

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QUARTERS CORPORATE

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:

Contact Person:

Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Sara B. Shultz Biomet Manufacturing, Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46582 Phone: [phone] FAX: [phone]

Proprietary Name:

Common Name:

Classification Name:

Small Hammer Toe Pin

Arthrodesis pin

Screw, Fixation, Bone, Non-spinal, nonmetallic (888.3040).

Device Product Code:

87HWC

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Resorbable Hammer Toe Pin, Biomet, Inc. (K011137).

Intended Use: The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.

Device Description: The Small Hammer Toe Pin is made out of the oriented Lactosorb® material and is indicated for proximal interphalangeal joint (PIP) joint arthrodesis. LactoSorb® is a polyester derivative of L-Lactic and glycolic acids. Poly Llactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis into Llactic and glycolic acids, which are then metabolized by the body. The device has threads on one end and barbs on the other.

Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate.

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

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

बाह्य कड़ा बाद में बाद में बाद में बाद में कि में बाद में कि कि

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2002

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

Re: K021828

Trade/Device Name: Small Hammer Toe Pin Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 3, 2002 Received: June 4, 2002

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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ッ 無くてもたまあると、いつでもなくなるのです。 このアイティングのシートレール、アイティーの一般になるので、 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Stupt Rhodes

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 1 of 1 _ .

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510 (k) Number (if known) : K021828

Device Name: Small Hammer Toe Pin

. ·

Indications For Use:

· The Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)
	OR
Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K021828
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00007

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.