Product Code: MBV FDA class 2 21 CFR 888.3560

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Orthopedic

The semi-constrained cemented UHMWPE pegged polymer/metal/polymer patello/femorotibial knee prosthesis is an orthopedic implant used to resurface the knee joint in patients with degenerative joint disease, utilizing ultra-high molecular weight polyethylene bearing surfaces and bone cement for fixation. It is classified as FDA Class II under 21 CFR 888.3560 within the Orthopedic specialty, requiring 510(k) premarket clearance. The product code is MBV and it carries an implant flag. Full GMP quality system requirements apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: MBV
Device Class: FDA class 2
Regulation Number: 888.3560
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 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K010212	OFFSET TIBIAL TRAY	Feb 14, 2001	Substantially Equivalent	Biomet, Inc.
K884824	TRICON-M TOTAL KNEE SYSTEM	Nov 21, 1989	Substantially Equivalent for Some Indications	Richards Medical Co., Inc.
K873429	FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE	Oct 28, 1987	Substantially Equivalent	Protek, Inc.
K853730	FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP	Feb 18, 1986	Substantially Equivalent	Protek, Inc.
K833200	TRICON M TOTAL KNEE SYSTEM	Nov 29, 1983	Substantially Equivalent	Richards Medical Co., Inc.
K831441	POROCOAT FREEMAN/SAMUELSON TOTAL KNEE	Sep 01, 1983	Substantially Equivalent	Depuy, Inc.
K832302	MARK I TOTAL KNEE SYS. ARTHROPLASTY	Aug 16, 1983	Substantially Equivalent	Advanced Biosearch Assn.
K830726	MARK I & II TOTAL KNEE REPLACE. SYS	Jun 22, 1983	Substantially Equivalent	Advanced Biosearch Assn.
K823837	RMC TOTAL KNEE SYSTEM	Mar 29, 1983	Substantially Equivalent	Richard'S Medical Equip., Inc.
K830408	FREEMAN/SAMUELSON TOTAL KNEE	Feb 24, 1983	Substantially Equivalent	Depuy, Inc.
K822583	TOTAL KNEE SYSTEM	Oct 04, 1982	Substantially Equivalent	Richard'S Medical Equip., Inc.
K802921	ICLH TIBIAL PLATEAU	Jan 08, 1981	Substantially Equivalent	Depuy, Inc.
K780904	KNEE, TOTAL, FEMORAL & TIBIAL	Jun 22, 1978	Substantially Equivalent	Depuy, Inc.
K780284	TIBIAL PLATEU	Mar 15, 1978	Substantially Equivalent	Depuy, Inc.