Predicate Devices

K 820813

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is an implant designed to treat conditions like dislocation, pain, stiffness, and deformities associated with joint diseases, directly addressing medical issues to restore function or alleviate symptoms.

Diagnostic

No

Explanation: The device is an implantable prosthesis designed to supplement arthroplasty and act as a spacer, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "double-stemmed silicone prosthesis," which is a physical implant, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
Device Description: The Futura Biomedical Lesser Metatarsal Phalangeal Joint Implant is a prosthesis designed to be implanted into the body to replace or supplement a joint. It is a surgical device used within the body.
Intended Use: The intended uses listed are all related to treating conditions affecting the lesser metatarsophalangeal joint through surgical intervention and implantation.

Therefore, based on the description and intended use, this device is a surgical implant, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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
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

Product codes (comma separated list FDA assigned to the subject device)

KWH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lesser metatarsophalangeal joint

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K 820813

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 Biomedical
990 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:

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.

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 ●

1

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) product
configuration |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Product Name | Sutter Lesser Metatarsal
Phalangeal Joint Prosthesis | Lesser Metatarsal Phalangeal Joint
Prosthesis |
| 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 of
the lesser metatarsophalangeal
joint | Partial or complete dislocation of
the lesser metatarsophalangeal
joint |
| | Pain Associated with rheumatoid
or osteo-arthritis | Pain Associated with rheumatoid
or osteo-arthritis |
| | Repair of unsuccessful
arthroplasties of the lesser
metatarsophalangeal joint | Repair of unsuccessful
arthroplasties of the lesser
metatarsophalangeal joint |
| | Stiffness at the lesser
metatarsophalangeal joint
associated with joint disease | Stiffness at the lesser
metatarsophalangeal joint
associated with joint disease |
| | Kohler's disease | Kohler's disease |
| | Hammer toe deformity where the
proximal phalanx is dorsally
located on the metatarsal in a fixed
contracture state | Hammer toe deformity where the
proximal phalanx is dorsally
located on the metatarsal in a fixed
contracture state |

2

Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text "ko2 3531" is on the first line. The second line says "page 3 of 3".

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.

3

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.

4

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

5

Page of

4

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) | OR
Over-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
---------------	---------