Product Code: KWD FDA class 2 21 CFR 888.3730

Prosthesis, Toe, Hemi-, Phalangeal

Orthopedic

The Phalangeal Hemi Toe Prosthesis is an orthopedic implant designed to replace one articular surface of a toe joint, used to treat conditions such as arthritis or deformity of the toes while preserving some natural joint structure. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWD, regulated under 21 CFR 888.3730, in the Orthopedic medical specialty. This device is an implant.

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Basic Information

Product Code: KWD
Device Class: FDA class 2
Regulation Number: 888.3730
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250074	HYALEX® MTP Hemiarthroplasty Implant	Apr 03, 2026	Substantially Equivalent	Hyalex Orthopaedics, Inc.
K240268	Accu-Joint Hemi Implant	Feb 29, 2024	Substantially Equivalent	Accufix Surgical, Inc.
K221220	Montross Extremity Medical Hemi Implant System	Apr 19, 2023	Substantially Equivalent	Montross Extremity Medical
K222964	BioPoly Lesser Toe Hemiarthroplasty Implant	Nov 22, 2022	Substantially Equivalent	BioPoly, LLC
K201393	restor3d MTP Implant	May 25, 2022	Substantially Equivalent	Restor3D, Inc.
K203634	BioPoly Great Toe Hemiarthroplasty Implant	Feb 02, 2021	Substantially Equivalent	BioPoly, LLC
K200951	Accu-Joint Hemi Implant	Dec 08, 2020	Substantially Equivalent	Accufix Surgical, Inc.
K190261	BOSS Toe Fixation System	Aug 14, 2019	Substantially Equivalent	Arthrosurface, Inc.
K190543	Cannulated Hemi Implant	May 31, 2019	Substantially Equivalent	Vilex IN Tennessee, Inc.
K161279	Life Spine Metatarsal Hemi Implant	Feb 01, 2017	Substantially Equivalent	Life Spine, Inc.
K152454	HemiCAP MTP Resurfacing Hemi-Arthroplasty System	Apr 11, 2016	Substantially Equivalent	Arthrosurface, Inc.
K131377	HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT	Nov 19, 2013	Substantially Equivalent	Arthrosurface, Inc.
K131187	LESSER METATARSAL HEAD IMPLANT SYSTEM	Oct 22, 2013	Substantially Equivalent	Solana Surgical, LLC
K121973	BIOPRO HEMI-EDGE TOE SYSTEM	Oct 30, 2012	Substantially Equivalent	Biopro, Inc.
K120029	HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET	Feb 06, 2012	Substantially Equivalent	Solana Surgical, LLC
K113752	METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET	Feb 06, 2012	Substantially Equivalent	Solana Surgical, LLC
K102401	HEMI IMPLANT; MINI HEMI IMPLANT	Jul 20, 2011	Substantially Equivalent	Vilex, Inc.
K092047	ASCENSION METAL GREAT TOE SYSTEM	Jan 14, 2010	Substantially Equivalent	Ascension Orthopedics, Inc.
K090127	METATARSAL DECOMPRESSION IMPLANT, MODEL 100	May 01, 2009	Substantially Equivalent	Solana Surgical, LLC
K083469	METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000	Feb 13, 2009	Substantially Equivalent	Metasurg
K081876	OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING	Aug 01, 2008	Substantially Equivalent	Osteomed LP
K073635	SBI SR MTP TOE IMPLANT	Mar 19, 2008	Substantially Equivalent	Small Bone Innovations, Inc.
K073065	OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM	Feb 21, 2008	Substantially Equivalent	Osteomed LP
K072922	3S HEMI TOE	Nov 28, 2007	Substantially Equivalent	Trilliant Surgical, Ltd.
K071243	METAL HEMI IMPLANT	May 23, 2007	Substantially Equivalent	Orthopro, LLC
K070052	MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION	Mar 28, 2007	Substantially Equivalent	Vilex, Inc.
K063370	CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY	Jan 12, 2007	Substantially Equivalent	Arthrosurface, Inc.
K063058	ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS	Jan 03, 2007	Substantially Equivalent	Arthrex, Inc.
K062908	ORTHROPRO HEMI TOE	Nov 13, 2006	Substantially Equivalent	Orthopro, LLC
K062040	SBI TRIHEDRON MTP HEMI GT	Oct 03, 2006	Substantially Equivalent	Small Bone Innovations, Inc.
K060536	OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM	Jun 02, 2006	Substantially Equivalent	Osteomed LP
K060560	ASCENSION PYROSPHERE CMC/TMT	May 05, 2006	Substantially Equivalent	Ascension Orthopedics, Inc.
K041595	TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870	Nov 12, 2004	Substantially Equivalent	Biopro, Inc.
K023684	CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365	Mar 01, 2004	Substantially Equivalent	Vilex, Inc.
K031859	CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT	Feb 18, 2004	Substantially Equivalent	Arthrosurface, Inc.
K030319	ORTHOSPHERE CERAMIC SPHERICAL IMPLANT	Nov 26, 2003	Substantially Equivalent	Wrightmedicaltechnologyinc
K023770	K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)	Dec 12, 2002	Substantially Equivalent	Kinetikos Medical, Inc.
K021063	GREAT TOE IMPLANT	Jul 01, 2002	Substantially Equivalent	Signal Medical Corp.
K014164	GREAT TOE IMPLANT SYSTEM	Mar 12, 2002	Substantially Equivalent	Harmos Orthopaedics, Inc.
K003629	MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03	Feb 22, 2001	Substantially Equivalent	Terray Corp.
K971047	FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT	Jun 20, 1997	Substantially Equivalent	Nexa Orthopedics, Inc.
K911378	TOWNLEY GREAT TOE JOINT	Nov 22, 1991	Substantially Equivalent	Biopro, Inc.
K875249	SUTTER PHALANGEAL CAP	Feb 03, 1988	Substantially Equivalent	Sutter Biomedical, Inc.
K864492	SWANSON TITANIUM GREAT TOE IMPLANT	Apr 15, 1987	Substantially Equivalent	Dow Corning Wright
K861983	SUTTER LESSER METATARSAL CAP	Sep 08, 1986	Substantially Equivalent	Sutter Biomedical, Inc.
K781870	IMPLANT, H.P. CONDYLAR	Feb 09, 1979	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials