Argo Knotless

Argo Knotless Anchor reattaches soft tissue to bone in arthroscopic or open orthopedic procedures. Its threaded anchor and suture eyelet are made from PEEK and are supplied sterile on a…

Registry build 21.09.26

Argo Knotless Anchor reattaches soft tissue to bone in arthroscopic or open orthopedic procedures. Its threaded anchor and suture eyelet are made from PEEK and are supplied sterile on a single-use driver.

A UHMWPE retention suture holds the eyelet on the driver and may be incorporated into the repair. Repair sutures pass through the eyelet and may be tensioned and held on the driver cleat before fixation in a prepared bone hole.

Listed Item

4.75 mm Argo Knotless Anchor

Repair Support

The nonabsorbable anchor secures ligaments, tendons or joint capsules to bone. Appropriate postoperative immobilization supports the damaged tissue during healing. The implant is ethylene-oxide sterilized for single use.

7manufacturers in China registered for this device type
2catalogue numbers in this listing
16510(k) clearances naming this product code
1recall

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MBI
Manufacturer City Province Registered as Device types
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Renolit Hansen Packaging Tech. (BJ) Ltd. Beijing Beijing Contract manufacturer 1
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Suzhou Endophix Co., Ltd. Suzhou Jiangsu Manufacturer 17
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Argo Knotless
Listed by ConMed Corporation, United States
FDA product code MBI
Device type Fastener, Fixation, Nondegradable, Soft Tissue
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K251530
Record published 2021-09-25
Record revised 2025-12-23 (version 4)

Specifications

Specifications
MRI safety MR Safe
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Special storage condition: KEEP DRY

Catalogue Numbers

Catalogue numbers for Argo Knotless
Catalogue number Size Status
K55 5.5 MM In distribution
K475 4.75 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arthrex® Arthrex, Inc. 362
HNM Sports Medicine HNM Stainless, LLC. 150
Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors GM DOS Reis Industria E Comercio Ltda 78
Juggerknot® Biomet Orthopedics 77
Fastener, Fixation, Nondegradable, Soft Tissue Parcus Medical, LLC 74
endophix Suzhou Endophix Co., Ltd. 71
Titan Medline Industries, Inc. 68
TopLock Fusion Orthopedics, LLC 67
HNM Medical HNM Stainless, LLC. 59
Orthobutton CL Riverpoint Medical LLC 55
Apollo Medline Industries, Inc. 53
JuggerKnot Soft Anchor Riverpoint Medical LLC 46

Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K261363 2026-05-13
K253763 2026-01-29
K251530 2025-06-18
K244025 2025-01-28
K220757 2022-05-13
K193606 2020-01-22
K191204 2019-07-03
K190333 2019-03-18
K182439 2019-01-08
K182621 2019-01-04
K181120 2018-12-21
K182446 2018-12-19
K171725 2017-09-08
K163258 2017-01-25
K151037 2015-07-09
K133224 2014-01-03

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2017-04-17 Class II Mixed-up of materials/components Manufactured with the incorrect anchor outer body 56 units 2021-08-31

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