Product Code: KWH FDA class 2 21 CFR 888.3720

Prosthesis, Toe, Constrained, Polymer

Orthopedic

The Constrained Polymer Toe Prosthesis is an orthopedic implant made from polymer that replaces toe joints with a constrained articulation, used in the surgical management of severe toe joint disease, arthritis, or deformity. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before commercial distribution. The product code is KWH, regulated under 21 CFR 888.3720, in the Orthopedic medical specialty. This device is an implant.

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Basic Information

Product Code: KWH
Device Class: FDA class 2
Regulation Number: 888.3720
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K191966	NewPrim System	Feb 13, 2020	Substantially Equivalent	Brm Extremities
K190136	Fusion Silastic System	Oct 21, 2019	Substantially Equivalent	Fusion Orthopedics, LLC
K173491	RTS Lesser MTP Implant System	Feb 23, 2018	Substantially Equivalent	In2bones USA, LLC
K153609	RTS Flexible 1 MPJ Implant w/Grommets	Sep 08, 2016	Substantially Equivalent	In2bones USA, LLC
K102601	ORTHOFLEX ROD	Jan 14, 2011	Substantially Equivalent	Ortho-Pro, LLC
K023531	LESSER METATARSAL PHALANGEAL JOINT IMPLANT	Jan 17, 2003	Substantially Equivalent	Nexa Orthopedics, Inc.
K022887	INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM	Nov 26, 2002	Substantially Equivalent	Osteomed Corp.
K022886	METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM	Nov 25, 2002	Substantially Equivalent	Osteomed Corp.
K023562	MODIFICATION TO CLASSIC GREAT TOE IMPLANT	Nov 13, 2002	Substantially Equivalent	Nexa Orthopedics, Inc.
K023086	CLASSIC GREAT TOE IMPLANT	Oct 04, 2002	Substantially Equivalent	Nexa Orthopedics, Inc.
K994326	ASCENT KNEE SYSTEM	Jan 07, 2000	Substantially Equivalent	Biomet Manufacturing, Inc.
K981194	FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT	Jun 30, 1998	Substantially Equivalent	Nexa Orthopedics, Inc.
K946236	PROFIX CONFORMING PLUS TIBIAL INSERT	Jul 06, 1995	Substantially Equivalent	Smith & Nephew Richards, Inc.
K943354	SUTTER HAMMERTOE JOINT PROSTHESIS	Jun 12, 1995	Substantially Equivalent	Sutter Corp.
K905795	SGARLATO FLEXIBLE HINGE TOE IMPLANT	May 29, 1991	Substantially Equivalent	Sgarlato Laboratories, Inc.
K884739	SGARLATO LESSER TOE IMPLANT	May 18, 1989	Substantially Equivalent	Sgarlato Laboratories, Inc.
K823405	ZIMMER GREAT TOE	Jan 24, 1983	Substantially Equivalent	Zimmer, Inc.
K820813	LESSER METATARSAL PHALANG. JOINT PROSTH	May 21, 1982	Substantially Equivalent	Sutter Biomedical, Inc.
K801345	KAMPNER HINGED TOE PROSTHESIS	Jul 08, 1980	Substantially Equivalent	Biomedics
K801094	SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL	Jun 09, 1980	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K780132	IMPLANT, HINGE TOE, FLEX.	Feb 06, 1978	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials