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

AGC Knee System

163 catalogue numbers from 12-153380, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.

Registry build 21.09.26
21manufacturers in China registered for this device type
163catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JWH
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
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
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
b-ONE Medical (Beijing) Co., Ltd. Beijing Beijing Contract manufacturer 7
Changzhou Wastonortho Medical Appliance Co., Ltd. Changzhou Jiangsu Contract manufacturer 5

Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Record

Regulatory record for AGC Knee System
Listed by Biomet Orthopedics, United States
FDA product code JWH
Device type Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class Class 2
Regulation 21 CFR 888.3560
510(k) K912245
Record published 2015-10-24
Record revised 2025-05-30 (version 7)

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 AGC Knee System
Catalogue number Size Status
12-153380 10 MM 85 MM In distribution
12-153372 20 MM 80 MM In distribution
155188 18 MM 85 MM In distribution
12-155716 16 MM 83 MM In distribution
155186 16 MM 85 MM In distribution
155118 20 MM 65 MM In distribution
155738 18 MM 87 MM In distribution
12-155718 18 MM 83 MM In distribution
155754 14 MM 91 MM In distribution
159201 10 MM 65 MM In distribution
155308 10 MM 65 MM In distribution
155758 18 MM 91 MM In distribution
12-155636 16 MM 67 MM In distribution
159241 12 MM 65 MM In distribution
155314 16 MM 65 MM In distribution
155126 10 MM 70 MM In distribution
152955 67.5 MM In distribution
159223 12 MM 80 MM In distribution
159231 14 MM 85 MM In distribution
155136 20 MM 70 MM In distribution
159200 8 MM 65 MM In distribution
159204 16 MM 65 MM In distribution
159258 10 MM 80 MM In distribution
155508 8 MM 59 MM In distribution
152997 67.5 MM In distribution
12-155712 12 MM 83 MM In distribution
152989 67.5 MM In distribution
159203 14 MM 65 MM In distribution
155354 20 MM 75 MM In distribution
12-153318 20 MM 65 MM In distribution
155588 91 MM In distribution
155352 18 MM 75 MM In distribution
12-153334 18 MM 70 MM In distribution
155750 10 MM 91 MM In distribution
159230 12 MM 85 MM In distribution
155390 20 MM 85 MM In distribution
12-153384 14 MM 85 MM In distribution
12-155632 12 MM 67 MM In distribution
159259 12 MM 80 MM In distribution
159216 12 MM 75 MM In distribution
155332 16 MM 70 MM In distribution
155628 8 MM 67 MM In distribution
159217 14 MM 75 MM In distribution
155670 10 MM 75 MM In distribution
12-155630 10 MM 67 MM In distribution
12-153328 12 MM 70 MM In distribution
12-153364 12 MM 80 MM In distribution
155130 14 MM 70 MM In distribution
155310 12 MM 65 MM In distribution
152967 62.5 MM In distribution
159209 12 MM 70 MM In distribution
12-153352 18 MM 75 MM In distribution
12-153312 14 MM 65 MM In distribution
159208 10 MM 70 MM In distribution
12-155614 14 MM 63 MM In distribution
155132 16 MM 70 MM In distribution
12-155698 18 MM 79 MM In distribution
12-155676 16 MM 75 MM In distribution
12-153336 20 MM 70 MM In distribution
12-155610 10 MM 63 MM In distribution
155388 18 MM 85 MM In distribution
12-155700 20 MM 79 MM In distribution
12-155654 14 MM 71 MM In distribution
152987 67.5 MM In distribution
12-153382 12 MM 85 MM In distribution
152988 62.5 MM In distribution
155510 10 MM 59 MM In distribution
12-155694 14 MM 79 MM In distribution
155348 14 MM 75 MM In distribution
159211 16 MM 70 MM In distribution
155318 20 MM 65 MM In distribution
159212 18 MM 70 MM In distribution
159210 14 MM 70 MM In distribution
152965 67.5 MM In distribution
12-155638 18 MM 67 MM In distribution
12-153344 10 MM 75 MM In distribution
159202 12 MM 65 MM In distribution
12-155650 10 MM 71 MM In distribution
155166 14 MM 80 MM In distribution
155380 10 MM 85 MM In distribution
12-153308 10 MM 65 MM In distribution
12-155658 18 MM 71 MM In distribution
159246 10 MM 70 MM In distribution
155752 12 MM 91 MM In distribution
12-155714 14 MM 83 MM In distribution
159222 10 MM 80 MM In distribution
12-155690 10 MM 79 MM In distribution
152978 62.5 MM In distribution
152933 62.5 MM In distribution
159247 12 MM 70 MM In distribution
155330 14 MM 70 MM In distribution
159253 12 MM 75 MM In distribution
155178 8 MM 85 MM In distribution
155172 20 MM 80 MM In distribution
159218 16 MM 75 MM In distribution
159228 8 MM 85 MM In distribution
159240 10 MM 65 MM In distribution
12-153310 12 MM 65 MM In distribution
155162 10 MM 80 MM In distribution
159215 10 MM 75 MM In distribution
12-153390 20 MM 85 MM In distribution
12-153348 14 MM 75 MM In distribution
12-153314 16 MM 65 MM In distribution
155134 18 MM 70 MM In distribution
12-153354 20 MM 75 MM In distribution
155518 18 MM 59 MM In distribution
155734 14 MM 87 MM In distribution
12-153350 16 MM 75 MM In distribution
155324 8 MM 70 MM In distribution
12-153346 12 MM 75 MM In distribution
155583 71 MM In distribution
159225 16 MM 80 MM In distribution
159229 10 MM 85 MM In distribution
152953 62.5 MM In distribution
12-153330 14 MM 70 MM In distribution
12-155634 14 MM 67 MM In distribution
155584 75 MM In distribution
159213 20 MM 70 MM In distribution
12-155672 12 MM 75 MM In distribution
152963 62.5 MM In distribution
155580 59 MM In distribution
12-153362 10 MM 80 MM In distribution
12-155674 14 MM 75 MM In distribution
155378 8 MM 85 MM In distribution
155386 16 MM 85 MM In distribution
155344 10 MM 75 MM In distribution
155372 20 MM 80 MM In distribution
12-155670 10 MM 75 MM In distribution
155514 14 MM 59 MM In distribution
159224 14 MM 80 MM In distribution
159226 18 MM 80 MM In distribution
159219 18 MM 75 MM In distribution
12-155616 16 MM 63 MM In distribution
12-155618 18 MM 63 MM In distribution
12-153368 16 MM 80 MM In distribution
12-153366 14 MM 80 MM In distribution
155146 12 MM 75 MM In distribution
12-153332 16 MM 70 MM In distribution
12-155710 10 MM 83 MM In distribution
12-155656 16 MM 71 MM In distribution
12-153326 10 MM 70 MM In distribution
155732 12 MM 87 MM In distribution
12-153386 16 MM 85 MM In distribution
12-155678 18 MM 75 MM In distribution
155170 18 MM 80 MM In distribution
12-155696 16 MM 79 MM In distribution
12-155612 12 MM 63 MM In distribution
155368 16 MM 80 MM In distribution
159205 18 MM 65 MM In distribution
155364 12 MM 80 MM In distribution
155152 18 MM 75 MM In distribution
12-153316 18 MM 65 MM In distribution
12-155692 12 MM 79 MM In distribution
12-155652 12 MM 71 MM In distribution
155154 20 MM 75 MM In distribution
155148 14 MM 75 MM In distribution
155730 10 MM 87 MM In distribution
159252 10 MM 75 MM In distribution
155106 8 MM 65 MM In distribution
155180 10 MM 85 MM In distribution
155728 8 MM 87 MM In distribution
155607 In distribution
152977 62.5 MM In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Prophecy® Microport Orthopedics Inc. 4,423
Exult Knee Replacement System Corentec Co., Ltd. 1,770
Freedom Maxx Orthopedics Inc. 1,693
Legion Smith & Nephew, Inc. 1,534
MyKnee Medacta International SA 1,466
Journey Smith & Nephew, Inc. 1,339
Persona® Zimmer, Inc. 1,254
DJO Surgical Encore Medical, L.P. 1,131
U2 Total Knee System United Orthopedic Corp. 1,078
CKS Plus Shalby Advanced Technologies, Inc. 1,024
Lospa Modular Knee System Corentec Co., Ltd. 1,020
Natural-Knee® Zimmer, Inc. 980

Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K080528 2008-06-17
K022586 2002-08-15

Recalls Naming This Product

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

Recalls naming the identifiers of AGC Knee System
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Biomet, Inc. 510(k) number 2020-04-17 Class II Process control Potential presence of elevated endotoxin levels that exceed the specification limit 54 units 2021-06-25
Biomet, Inc. 510(k) number 2019-03-01 Class II Packaging process control Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. 809 total 2020-05-27
Biomet, Inc. 510(k) number 2019-03-01 Class II Packaging process control Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. 809 units total 2020-05-27
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 2017-08-25 Class II Process change control The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. 28 devices 2018-08-09
Biomet, Inc. 510(k) number 2017-08-25 Class II Process change control The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension. 11 devices 2018-08-09
Biomet, Inc. 510(k) number 2007-07-24 Not classified Labeling mix-ups Incorrect Product — Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm. 4 2008-07-24
Biomet, Inc. 510(k) number 2007-07-24 Not classified Labeling mix-ups Incorrect Product — Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm. 1 2008-07-24

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer