Surestitch™ Uhmwpe Suture PEEK Button Meniscus Repair Implant-UP
SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device. Two nonabsorbable PEEK polymer implants are connected by a preloaded UHMWPE suture to…
SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device. Two nonabsorbable PEEK polymer implants are connected by a preloaded UHMWPE suture to retain the suture during soft tissue repair.
The implants are delivered through a needle. An adjustable depth-control knob sets the exposed needle length before implant deployment, and different needle curvatures accommodate the approach to the repair site.
Implant and Suture Options
The standard implant uses USP #3-0 UHMWPE suture; the XL version uses USP #2-0 suture and larger-diameter PEEK implants. The listed UP configuration belongs to a family that also offers LEFT, RIGHT and DOWN delivery needles. The devices are supplied after ethylene oxide sterilization.
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 | Healthium Medtech Limited, India |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K230891 |
| Record published | 2024-07-30 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S29-1800-TQ | In distribution | |
| S29-1802-TQ | In distribution | |
| S29-1801-TQ | In distribution | |
| S29-1803-TQ | 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 |
|---|---|
| K231033 | 2024-01-04 |
| K230891 | 2023-12-28 |
| K232886 | 2023-11-08 |
| K231404 | 2023-08-04 |
| K223889 | 2023-03-22 |
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.