Exoshape
EXOSHAPE SOFT TISSUE FASTENER TIBIAL, 10 MM x 30 MM
7manufacturers in China registered for this device type
8catalogue 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.
| 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) | K101808 |
| Record published | 2020-11-30 |
| Record revised | 2025-04-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
| Sizes | Outer diameter 8 to 11 mm |
| Distribution end date | 2025-04-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1101-00-0730 | In distribution | |
| 1101-00-0930 | In distribution | |
| 1101-00-0830 | In distribution | |
| 1600-00-011 | Outer Diameter 11 mm | Withdrawn |
| 1600-00-009 | Outer Diameter 9 mm | Withdrawn |
| 1600-00-010 | Outer Diameter 10 mm | Withdrawn |
| 1101-00-1030 | Withdrawn | |
| 1600-00-008 | Outer Diameter 8 mm | Withdrawn |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 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 | Closed |
|---|---|---|---|---|---|---|---|
| Medshape, Inc. | 510(k) number | 2013-04-04 | Class II | Error in labeling | Expiration date on the patient label and date on the product carton were not the same. | 26 | 2013-08-07 |
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.