Who else makes this device?

Name: Maxim® Knee System
Brand: Maxim® Knee System

Orthopedic › ProstheticProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Maxim® Knee System

Catalogue number 140075, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26

10manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRY
Manufacturer	City	Province	Registered as	Device types
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34
Suzhou Microport Orthorecon Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	31

Record

Regulatory record for Maxim® Knee System
Listed by	Biomet Orthopedics, United States
FDA product code	HRY
Device type	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class	Class 2
Regulation	21 CFR 888.3530
510(k)	K033489
Record published	2020-05-18
Record revised	2025-05-30 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Maxim® Knee System
Catalogue number	Size	Status
140075	80MM	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Legion	Smith & Nephew, Inc.	1,682
Genesis II	Smith & Nephew, Inc.	615
Journey II	Smith & Nephew, Inc.	581
Evolution	Microport Orthopedics Inc.	311
Profix	Smith & Nephew, Inc.	293
Journey	Smith & Nephew, Inc.	215
LinkSymphoKnee	Waldemar Link GmbH & Co. KG	201
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Smith & Nephew, Inc.	160
JII	Smith & Nephew, Inc.	141
Physica KR	Limacorporate	128
Physica LMC	Limacorporate	120
Implant Partners	Microport Orthopedics Inc.	119

Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K020264	2002-02-08

Recalls Naming This Product

9 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Maxim® Knee System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2018-12-21	Class II	Under Investigation by firm	Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.	90 units	2020-05-13
Biomet, Inc.	510(k) number	2018-05-24	Class II	Under Investigation by firm	Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.	48	2020-04-07
Biomet, Inc.	510(k) number	2018-05-18	Class II	Under Investigation by firm	One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.	16	2020-03-31
Biomet, Inc.	510(k) number	2018-05-11	Class II	Under Investigation by firm	The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.	169	2019-11-21
Biomet, Inc.	510(k) number	2015-04-16	Class III	Labeling mix-ups	Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.	1315	2016-05-16
Biomet, Inc.	510(k) number	2011-03-03	Not classified	Packaging process control	The firm is recalling the product due to the product’s packaging being labeled “I-Beam 75mm. Tibial Plate”, but the package actually contains the “Interlok 67mm. CR Tibial Plate”.	8	2011-07-27
Biomet, Inc.	510(k) number	2007-12-12	Not classified	Packaging process control	Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.	8	2008-06-11
Biomet, Inc.	510(k) number	2007-12-12	Not classified	Packaging process control	Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.	8	2008-06-11
Biomet, Inc.	510(k) number	2007-09-18	Not classified	Labeling mix-ups	Mislabeled as to size: the package actaully contained a 71 mm tray.	7	2008-06-04

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P840049	1988-09-30	P.C.A.(TM) TOTAL KNEE SYSTEM	Howmedica Corp.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.