Partial or complete dislocation of the lesser metatarsophalangeal joint
Pain Associated with rheumatoid or osteoarthritis
Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint .
Stiffness at the lesser metatarsophalangeal joint associated with joint disease
Kohler's disease
Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state

Device Description

The Lesser Metatarsal Phalangeal Joint Implant is a double-stemmed silicone prosthesis, intended to supplement lesser metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the metatarsal and base of the proximal phalanx.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Lesser Metatarsal Phalangeal Joint Implant." It's a submission to the FDA (Food and Drug Administration) to demonstrate that this new device is substantially equivalent to a legally marketed predicate device, the "Sutter Lesser Metatarsal Phalangeal Joint Prosthesis."

The regulatory path for this device is based on substantial equivalence, not on meeting specific acceptance criteria derived from a performance study against a predefined standard. Therefore, many of the requested items, such as a table of acceptance criteria with reported device performance, sample sizes for test/training sets, expert qualifications, and study designs (MRMC, standalone), are typically associated with performance-based regulatory clearances or approvals (like de novo classification or PMA applications) rather than 510(k) submissions demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. This submission is for a medical device seeking 510(k) clearance based on substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria from a clinical or analytical study. The "acceptance criteria" here implicitly refer to demonstrating equivalence in design, materials, indications for use, and technological characteristics to the predicate device.

The comparison provided is qualitative, highlighting similarities between the proposed device and the predicate:

Item	Proposed (LMP) product configuration	Similarity to Predicate (Sutter Biomedical LMP)
Product Name	Lesser Metatarsal Phalangeal Joint Prosthesis	Similar (minor variation)
Use	Single use	Identical
Fixation	Stem in intramedullary canal	Identical
Constraint	Constrained	Identical
Material	Silicone	Identical
Sizes	4 sizes (20, 30, 40, 50)	Different (predicate has 8 sizes)
Indications for use	Partial or complete dislocation of the lesser metatarsophalangeal joint; Pain Associated with rheumatoid or osteoarthritis; Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint; Stiffness at the lesser metatarsophalangeal joint associated with joint disease; Kohler's disease; Hammer toe deformity	Identical

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

Not Applicable. No "test set" in the context of a clinical performance study is described. The submission focuses on comparing the proposed device's characteristics to a predicate device.

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

Not Applicable. No expert-adjudicated test set is described. The "ground truth" for this 510(k) is the demonstrated similarity to the predicate device's design and intended use, as reviewed by the FDA.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or associated adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

Not Applicable. This is a device for surgical implantation, not an imaging diagnostic device that would typically undergo an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This is a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used:

For this 510(k) submission, the "ground truth" for the substantial equivalence determination is the characteristics and performance of the legally marketed predicate device (Sutter Lesser Metatarsal Phalangeal Joint Prosthesis) combined with the design specifications and intended use of the proposed device. The evaluation relies on demonstrating that the new device does not raise different questions of safety and effectiveness compared to the predicate.

8. The Sample Size for the Training Set:

Not Applicable. No "training set" in the context of an AI/ML algorithm is described.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. No training set is described.

Summary

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510 (k) Summary

023531
page 1 of 3

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

JAN 1 7 2003

Prepared:	October 18, 2002
Applicant:	Futura Biomedical990 Park Center Drive Su

990 Park Center Drive, Suite H Vista, CA 92083

Telephone:	760-599-1670
Fax:	760-599-1675
Contact:	Louise M. Focht

Device Name:
Device Trade Name:
Device Classification:
Reviewing Panel:
Regulation Number
Product Code:
Original Predicate Device:

Registration Number: Owner Operator Number: Prosthesis, Toe, Constrained, Polymer Lesser Metatarsal Phalangeal Joint Implant Class II Orthopedic 888.3720 87 KWH Sutter Lesser Metatarsal Phalangeal Joint Prosthesis K 820813, Currently sold by Futura Biomedical 2030833 9028319

、

Device Description:

Indications for Use:

Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for:

Partial or complete dislocation of the lesser metatarsophalangeal joint
Pain Associated with rheumatoid or osteoarthritis ●

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023531
page 20f3

Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint .
Stiffness at the lesser metatarsophalangeal joint associated with joint disease ●
Kohler's disease ●
Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal ● in a fixed contracture state

Comparison to the Original Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Sutter Lesser Metatarsal Phalangeal Joint Prosthesis.

Regulatory Class:	II
Product Code:	87 KWH

Table Comparison of original Sutter Biomedical Lesser Metatarsal Phalangeal Joint Prosthesis to the new configuration Lesser Metatarsal Phalangeal Joint.

Item	Sutter Biomedical (LMP)	Proposed (LMP) productconfiguration
Product Name	Sutter Lesser MetatarsalPhalangeal Joint Prosthesis	Lesser Metatarsal Phalangeal JointProsthesis
Use	Single use	Single use
Fixation	stem in intramedulary canal	stem in intramedulary canal
Constraint	Constrained	Constrained
Material	Silicone	Silicone
Sizes	8 sizes, S5, S7, M5, M7, M10, L5,L7, L10	4 sizes 20, 30, 40, 50
Indications for use	Partial or complete dislocation ofthe lesser metatarsophalangealjoint	Partial or complete dislocation ofthe lesser metatarsophalangealjoint
	Pain Associated with rheumatoidor osteo-arthritis	Pain Associated with rheumatoidor osteo-arthritis
	Repair of unsuccessfularthroplasties of the lessermetatarsophalangeal joint	Repair of unsuccessfularthroplasties of the lessermetatarsophalangeal joint
	Stiffness at the lessermetatarsophalangeal jointassociated with joint disease	Stiffness at the lessermetatarsophalangeal jointassociated with joint disease
	Kohler's disease	Kohler's disease
	Hammer toe deformity where theproximal phalanx is dorsallylocated on the metatarsal in a fixedcontracture state	Hammer toe deformity where theproximal phalanx is dorsallylocated on the metatarsal in a fixedcontracture state

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Similarities of the Sutter Lesser Metatarsal Phalangeal Joint Prosthesis and the Futura Biomedical Lesser Metatarsal Phalangeal Joint Prosthesis include;

Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the lesser metatarsal and phalangeal bones; Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, composed of three curved lines. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92083

Re: K023531

Trade Name: Lesser Metatarsal Phalangeal Joint Implant Regulation Number: 21 CFR 888.3720 Regulation Name: Toe ioint polymer constrained prosthesis Regulatory Class: II Product Code: KWH Dated: October 18, 2002 Received: October 21, 2002

Dear Ms. Focht:

We have reviewed your Section 510(k) premarket 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) 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. Louise M. Focht

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 Office of Compliance at (301) 594-4659. 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,
Mark A. Millerson

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 of

510 (k) Number (If Known):_K O035 31 Device Name: Lesser Metatarsal Phalangeal Joint Implant

Indications for Use:

Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is indicated for:

. Partial or complete dislocation of the lesser metatarsophalangeal joint
Pain Associated with rheumatoid or osteo-arthritis ●
Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint .
Stiffness at the lesser metatarsophalangeal joint associated with joint disease ●
Kohler's disease .
. Hammer toe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state

(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)	OROver-the-Counter-Use(Optional Format 1-2-96)
--------------------------------------------	--------------------------------------------------------

for Mark N. Melkers

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K023531
---------------	---------

Regulation Number and Section

§ 888.3720 Toe joint polymer constrained prosthesis.

(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.