Draw Tight
Draw Tight anchors attach soft tissue to bone using a suture-based fixation mechanism. Once inserted into a prepared bone socket, the anchor is deployed through the included suture to form…
Draw Tight anchors attach soft tissue to bone using a suture-based fixation mechanism. Once inserted into a prepared bone socket, the anchor is deployed through the included suture to form a suture ball that holds the construct in place.
The anchors use ultra-high-molecular-weight polyethylene and PEEK. They accommodate both sliding and fixed sutures for soft tissue fixation and are supplied sterile.
Listed Item
3.2mm Draw Tight Suture Anchor with One Suture and One Suture Tape
Repair Applications
Applications include rotator cuff and labral repairs, shoulder stabilization, biceps tenodesis, collateral ligament repairs and tendon avulsion repairs. The family also has indications for selected foot, ankle, elbow, hand and wrist procedures, including Achilles tendon repair and scapholunate ligament reconstruction.
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 | Parcus Medical, LLC, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K122805 |
| Record published | 2015-10-22 |
| Record revised | 2019-03-21 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10566 | 6 | In distribution | |
| 11151 | In distribution | ||
| 10820 | 6 | In distribution | |
| 11034 | In distribution | ||
| 10565 | 6 | In distribution | |
| 10820 | In distribution | ||
| 10588 | In distribution | ||
| 11288 | In distribution | ||
| 10588 | 6 | In distribution | |
| 11150 | In distribution | ||
| 10565 | In distribution | ||
| 11289 | In distribution | ||
| 11297 | In distribution | ||
| 11148 | In distribution |
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 |
|---|---|
| K221502 | 2022-07-26 |
| K221135 | 2022-05-19 |
| K212739 | 2021-10-06 |
| K202662 | 2021-02-22 |
| K202259 | 2020-10-28 |
| K201083 | 2020-07-23 |
| K193295 | 2020-01-23 |
| K192750 | 2020-01-16 |
| K192964 | 2019-11-22 |
| K191783 | 2019-10-09 |
| K190375 | 2019-04-24 |
| K183331 | 2019-02-07 |
| K170877 | 2017-06-02 |
| K170327 | 2017-03-30 |
| K162198 | 2016-11-18 |
| K152711 | 2015-11-20 |
| K133757 | 2014-02-04 |
| K122805 | 2013-02-05 |
| K120942 | 2012-04-20 |
| K113730 | 2012-01-17 |
| K091094 | 2009-09-30 |
| K090923 | 2009-06-30 |
| K090075 | 2009-03-06 |
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.