Grappler Suture Anchor System
Grappler Suture Anchor System attaches soft tissue to bone using anchors, sutures and placement instruments. Anchor options include PEEK, titanium and suture-based designs in different…
Grappler Suture Anchor System attaches soft tissue to bone using anchors, sutures and placement instruments. Anchor options include PEEK, titanium and suture-based designs in different sizes and lengths.
Round sutures or suture tapes connect the repair tissue to the anchor. The family includes anchor-and-driver kits, with the selected configuration determining which sutures and other components are supplied.
Listed Item
Grappler Knotless Anchor, PEEK, ø5.5 x 15mm, Anchor/Driver only, Sterile Kit
Repair Configurations
The listed family includes a sterile 5.5 mm PEEK knotless anchor-and-driver kit. Applications span tendon and ligament repairs at the shoulder, elbow, knee, hip, hand, wrist, foot and ankle. Anchors designed to interact with plates are limited to the specified hand, wrist, foot and ankle applications.
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 | Paragon 28, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K231867 |
| Record published | 2023-02-09 |
| Record revised | 2025-04-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P82-240-4820-SK | In distribution | |
| P44-121-5515-SK | In distribution | |
| P44-310-0004-S | In distribution | |
| P44-130-4515-SK | In distribution | |
| P44-121-4515-SK | In distribution | |
| P44-120-5515-SK | In distribution | |
| P44-111-3012-SK | In distribution | |
| P82-211-0028-SK | In distribution | |
| P44-300-0004-S | In distribution | |
| P44-130-5515-SK | In distribution | |
| P44-120-4515-SK | In distribution | |
| P82-220-4212-SK | In distribution | |
| P44-310-4515-SK | In distribution | |
| P44-110-4515-SK | In distribution | |
| P44-132-4515-SK | In distribution | |
| P44-131-5515-SK | In distribution | |
| P82-230-3500-SK | In distribution | |
| P44-131-4515-SK | In distribution | |
| P44-300-4515-SK | In distribution | |
| P44-110-3010-SK | In distribution | |
| P82-111-4515-SK | 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 |
|---|---|
| K262047 | 2026-08-03 |
| K253886 | 2026-03-17 |
| K241864 | 2024-07-25 |
| K240594 | 2024-03-26 |
| K231867 | 2023-08-21 |
| K223589 | 2023-03-03 |
| K222091 | 2022-09-14 |
| K211322 | 2021-08-30 |
| K211002 | 2021-07-07 |
| K203385 | 2021-02-11 |
| K191227 | 2020-01-24 |
| K183690 | 2019-03-01 |
| K182898 | 2019-01-14 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Paragon 28 | 510(k) number | 2022-07-13 | Class II | Device Design | Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery. | 145 |
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.