Product Code: LZJ FDA unclassified

Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

Unknown

The Semi-Constrained Metal/Polymer Metatarsophalangeal Toe Joint Prosthesis (product code LZJ) is a surgically implanted orthopedic device used to replace the metatarsophalangeal joint of the toe in patients with severe arthritis or joint deformity, using a metal and polymer composite design. It is currently unclassified (Class U) with no assigned regulation number, and is reviewed under the Orthopedic (OR) panel. The device is flagged as an implant. As an unclassified device, its regulatory pathway has not been fully determined.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LZJ
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132496	ARTHROSURFACE TOEMOTION	Feb 26, 2014	Substantially Equivalent	Arthrosurface, Inc.
K102549	THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY	Dec 21, 2010	Substantially Equivalent	Ascension Orthopedics, Inc.
K072251	MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM	May 08, 2008	Substantially Equivalent	Merete Medical GmbH
K950864	GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)	Jul 31, 1995	Substantially Equivalent	Acu Med, Inc.
K941650	TOTAL TOE SYSTEM II	Dec 19, 1994	Substantially Equivalent	Biomet, Inc.
K924724	KINETIK GREAT TOE SYSTEM	Jan 05, 1994	Substantially Equivalent	Kinetikos Medical, Inc.
K922211	OSTEOMED GREAT TOE SYSTEM	Nov 09, 1993	Substantially Equivalent for Some Indications	Osteomed Corp.
K920446	TOTAL TOE SYSTEM	Mar 22, 1993	Substantially Equivalent	Biomet, Inc.
K920667	GREAT TOE IMPLANT	Jun 19, 1992	Substantially Equivalent	Acu Med, Inc.
K911552	ANATOMIC TOE SYSTEM	Jun 28, 1991	Substantially Equivalent	Orthopaedic Biosystems
K884561	KOENIG TOTAL TOE IMPLANT	Jan 24, 1989	Substantially Equivalent for Some Indications	Dow Corning Wright