Compress® OSS™

Catalogue number 110018816, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (3), 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 KRO
Manufacturer City Province Registered as Device types
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
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54

Record

Regulatory record for Compress® OSS™
Listed by Biomet Orthopedics, United States
FDA product code KRO
Device type Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class Class 2
Regulation 21 CFR 888.3510
510(k) K141331
Record published 2021-04-30
Record revised 2025-05-30 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Compress® OSS™
Catalogue number Size Status
110018816 5 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Link Endo-Model EVO Knee System Waldemar Link GmbH & Co. KG 324
Endo-Model Modular Knee Prosthesis System Waldemar Link GmbH & Co. KG 291
LinkSymphoKnee Waldemar Link GmbH & Co. KG 263
Evolution Microport Orthopedics Inc. 223
Legion Smith & Nephew, Inc. 222
OSS™ Orthopedic Salvage System Biomet Orthopedics 211
Ustar II Knee System United Orthopedic Corp. 185
“united” Ustar II Knee System United Orthopedic Corp. 162
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Zimmer, Inc. 157
Finn Knee System Biomet Orthopedics 138
NexGen Zimmer, Inc. 119
Triathlon Howmedica Osteonics Corp 106

Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K131393 2013-10-24
K020381 2002-05-06

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