Y-Knot, OneStep
Y-Knot OneStep is a nonabsorbable suture-anchor system for reattaching soft tissue to bone. The anchor is made from high-strength flat braided suture and comes preloaded on a disposable…
Y-Knot OneStep is a nonabsorbable suture-anchor system for reattaching soft tissue to bone. The anchor is made from high-strength flat braided suture and comes preloaded on a disposable inserter.
Configurations carry one or two number 2 Hi-Fi suture strands or suture ribbon. Once anchored in bone, the suture connects tissue such as a ligament, tendon or joint capsule to the fixation point. The filed single-suture black Hi-Fi anchor is one configuration.
Listed Item
Y-Knot® OneStep™ Anchor, One #2 Hi-Fi (Black)
Anchor and Inserter Design
The anchor uses a press-fit, expandable design with a flexible inserter that also provides the pilot-hole drilling function. It is intended for arthroscopic or open procedures. The anchor, sutures and disposable inserter are ethylene oxide sterilized for single use.
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.
| 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
| 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) | K193606 |
| Record published | 2020-04-15 |
| Record revised | 2023-07-19 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: KEEP DRY |
| Distribution end date | 2023-07-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Y1S1K | Withdrawn | |
| Y1S2 | Withdrawn | |
| Y1S1RB | Withdrawn | |
| Y1S1B | Withdrawn | |
| Y1S2 | Withdrawn | |
| Y1S2R | Withdrawn | |
| Y1S1B | Withdrawn | |
| Y1S1K | Withdrawn | |
| Y1S1RK | Withdrawn |
Same 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
| 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.
| 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.