Orthopedic › SurgicalReamer

InSitu Hip System

Acetabular Reamer, Full Hemisphere, Bridgeback, Ruijin, Size 67

Registry build 21.09.26
23manufacturers in China registered for this device type
181catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTO
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Changzhou Master Precision Tool Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38

Showing 12 of 23. All 23 manufacturers in China registered for Reamer

Record

Regulatory record for InSitu Hip System
Listed by Nextstep Arthropedix, United States
FDA product code HTO
Device type Reamer
Device class Class 1
Regulation 21 CFR 888.4540
Record published 2026-06-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number
Distribution end date 2023-08-30
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for InSitu Hip System
Catalogue number Size Status
10-83-0460 In distribution
10-83-0567 In distribution
10-83-0542 In distribution
10-83-0140 In distribution
10-83-0040 In distribution
10-83-0469 In distribution
10-83-0042 In distribution
10-83-0060 In distribution
10-83-0152 In distribution
10-83-0051 In distribution
10-83-0049 In distribution
10-83-0059 In distribution
10-83-0461 In distribution
10-83-0061 In distribution
10-83-0250 In distribution
10-83-0541 In distribution
10-83-0468 In distribution
10-83-0148 In distribution
10-83-0244 In distribution
10-83-0070 In distribution
10-83-0566 In distribution
10-83-0344 In distribution
10-83-0462 In distribution
10-83-0353 In distribution
10-83-0240 In distribution
10-83-0564 In distribution
10-83-0043 In distribution
10-83-0046 In distribution
10-83-0458 In distribution
10-83-0369 In distribution
10-83-0138 In distribution
10-83-0259 In distribution
10-83-0064 In distribution
10-83-0058 In distribution
10-83-0262 In distribution
10-83-0559 In distribution
10-83-0451 In distribution
10-83-0366 In distribution
10-83-0054 In distribution
10-83-0057 In distribution
10-83-0556 In distribution
10-83-0258 In distribution
10-83-0356 In distribution
10-83-0041 In distribution
10-83-0544 In distribution
10-83-0456 In distribution
10-83-0453 In distribution
10-83-0442 In distribution
10-83-0067 In distribution
10-83-0561 In distribution
10-83-0547 In distribution
10-83-0251 In distribution
10-83-0448 In distribution
10-83-0554 In distribution
10-83-0545 In distribution
10-83-0346 In distribution
10-83-0365 In distribution
10-83-0558 In distribution
10-83-0269 In distribution
10-83-0166 In distribution
10-83-0360 In distribution
10-83-0452 In distribution
10-83-0443 In distribution
10-83-0351 In distribution
10-83-0267 In distribution
10-83-0264 In distribution
10-83-0457 In distribution
10-83-0459 In distribution
10-83-0270 In distribution
10-83-0045 In distribution
10-83-0354 In distribution
10-83-0158 In distribution
10-83-0069 In distribution
10-80-0313 In distribution
10-83-0261 In distribution
10-83-0368 In distribution
10-83-0263 In distribution
10-83-0565 In distribution
10-83-0367 In distribution
10-83-0549 In distribution
10-83-0053 In distribution
10-83-0445 In distribution
10-83-0268 In distribution
10-83-0256 In distribution
10-83-0048 In distribution
10-83-0546 In distribution
00816127026133 In distribution
10-83-0265 In distribution
10-83-0146 In distribution
10-83-0563 In distribution
10-83-0142 In distribution
10-83-0470 In distribution
10-83-0239 In distribution
10-83-0568 In distribution
10-83-0438 In distribution
10-83-0038 In distribution
10-83-0241 In distribution
10-83-0569 In distribution
10-83-0243 In distribution
10-83-0050 In distribution
10-83-0361 In distribution
10-83-0246 In distribution
10-83-0068 In distribution
10-83-0363 In distribution
10-83-0539 In distribution
10-83-0348 In distribution
10-83-0570 In distribution
10-83-0150 In distribution
10-83-0355 In distribution
10-83-0144 In distribution
10-83-0257 In distribution
10-83-0466 In distribution
10-83-0441 In distribution
10-83-0450 In distribution
10-83-0249 In distribution
10-83-0357 In distribution
10-83-0455 In distribution
10-83-0338 In distribution
10-83-0253 In distribution
10-83-0557 In distribution
10-83-0538 In distribution
10-83-0055 In distribution
10-83-0349 In distribution
10-83-0266 In distribution
10-83-0047 In distribution
10-83-0359 In distribution
10-83-0063 In distribution
10-83-0467 In distribution
10-83-0052 In distribution
10-83-0162 In distribution
10-83-0347 In distribution
10-83-0245 In distribution
10-83-0463 In distribution
10-83-0044 In distribution
10-83-0439 In distribution
10-83-0550 In distribution
10-83-0343 In distribution
10-83-0170 In distribution
10-83-0444 In distribution
10-83-0255 In distribution
10-83-0454 In distribution
10-83-0358 In distribution
10-83-0039 In distribution
10-83-0252 In distribution
10-83-0350 In distribution
10-83-0342 In distribution
10-83-0555 In distribution
10-83-0341 In distribution
10-83-0560 In distribution
10-83-0548 In distribution
10-83-0260 In distribution
10-83-0154 In distribution
10-83-0164 In distribution
10-83-0362 In distribution
10-83-0447 In distribution
10-83-0156 In distribution
10-83-0242 In distribution
10-83-0247 In distribution
10-83-0248 In distribution
10-83-0446 In distribution
10-83-0056 In distribution
10-83-0066 In distribution
10-83-0540 In distribution
10-83-0553 In distribution
10-83-0464 In distribution
10-83-0370 In distribution
10-83-0551 In distribution
10-83-0562 In distribution
10-83-0340 In distribution
10-83-0552 In distribution
10-83-0449 In distribution
10-83-0168 In distribution
10-83-0065 In distribution
10-83-0238 In distribution
10-83-0160 In distribution
10-83-0465 In distribution
10-83-0364 In distribution
10-83-0352 In distribution
10-83-0543 In distribution
10-83-0254 In distribution
10-83-0062 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Trigen Smith & Nephew, Inc. 1,029
Viant Medical, LLC Viant Medical, LLC 825
R3 Smith & Nephew, Inc. 287
Reamer Ortho Development Corp. 259
Apex Knee System Omni Life Science, Inc. 162
Reamer Synthes Gmbh 152
Reclaim Depuy (Ireland) 138
Reamer Zimmer, Inc. 135
Endo-Model Knee System – Instruments Waldemar Link GmbH & Co. KG 109
DJO Surgical Encore Medical, L.P. 108
Arthrex® Arthrex, Inc. 105
Arthrex Provision 98

Showing 12 of 1,224. All products under Reamer

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