Product Code: KWM FDA class 2 21 CFR 888.3800

Prosthesis, Wrist, Semi-Constrained

Orthopedic

The Semi-Constrained Wrist Prosthesis is an orthopedic implant that replaces the wrist joint with a design allowing some degree of constraint to motion while maintaining partial reliance on surrounding soft tissues for stability, used in patients with severe wrist joint degeneration or rheumatoid arthritis. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWM, regulated under 21 CFR 888.3800, in the Orthopedic medical specialty. This device is an implant.

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510(k)s

FEI Numbers

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Basic Information

Product Code: KWM
Device Class: FDA class 2
Regulation Number: 888.3800
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 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K880156	VOLZ TOTAL WRIST PROSTHESIS	Feb 17, 1988	Substantially Equivalent	Biomet, Inc.
K872502	M.W.P. WRIST PROSTHESIS	Jul 23, 1987	Substantially Equivalent	Protek, Inc.
K803031	LAURE WRIST IMPLANT	Jun 29, 1982	Substantially Equivalent	Laure Prosthetics, Inc.
K800602	TALEISNIK TOTAL WRIST PROSTHESIS	Aug 27, 1980	Substantially Equivalent	Dow Corning Wright
K801157	WEBER-MAYO WRIST	Aug 04, 1980	Substantially Equivalent	Depuy, Inc.
K790774	LODA WRIST PROSTHESIS	Aug 03, 1979	Substantially Equivalent	Depuy, Inc.