Inbone
Tibial Tray
1manufacturer
236catalogue numbers in this listing
9recalls on this code
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | HSN |
| Device type | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3110 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K051023 |
| Record published | 2016-09-17 |
| Record revised | 2023-01-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 6 to 20 mm; outer diameter 4.8 to 18 mm; length 10 to 14 mm |
| Distribution end date | 2016-03-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IB222208 | Size 2 | In distribution |
| IB223312 | Size 3 | In distribution |
| 220222208E | Size: 2 | In distribution |
| 200221960E | Height 9 mm | In distribution |
| IB206611 | Height 11 mm | In distribution |
| IB226609 | Height 9 mm | In distribution |
| 220252903 | Size: 3 Long | In distribution |
| 200223213E | Height 13 mm | In distribution |
| IB220904 | Size: 4 | In distribution |
| 200420002 | Large | In distribution |
| 200550004 | Size: 4 | In distribution |
| 200223211E | Height 11 mm | In distribution |
| 220225416E | Height 16 mm | In distribution |
| IB282903 | Size: 3 | In distribution |
| 220226613E | Height 13 mm | In distribution |
| IB224413 | Size 4 | In distribution |
| 220225420E | Size: 4+ | In distribution |
| 200222903 | Size: 3 | In distribution |
| IB224312 | Height 12 mm | In distribution |
| 220225511E | Height 11 mm | In distribution |
| 200224316E | Size: 3+ | In distribution |
| 220223210E | Height 10 mm | In distribution |
| IB206615 | Height 15 mm | In distribution |
| IB224409 | Size 4 | In distribution |
| 220252904 | Size: 4 Long | In distribution |
| 220224316E | Height 16 mm | In distribution |
| 200252903 | Left | In distribution |
| 200226516E | Size: 5+ | In distribution |
| 200010904 | Outer Diameter 12 mm | In distribution |
| 200226512E | Size: 5+ | In distribution |
| IB205410 | Height 10 mm | In distribution |
| 220223312E | Size: 3 | In distribution |
| 200225414E | Size: 4+ | In distribution |
| IB282906 | Size: 6 | In distribution |
| 220225418E | Height 18 mm | In distribution |
| 200009901 | Outer Diameter 16 mm | In distribution |
| 200225412E | Height 12 mm | In distribution |
| IB223314 | Height 14 mm | In distribution |
| 200221936E | Height 14 mm | In distribution |
| 220225519E | Size: 5 | In distribution |
| 200221920E | Size: 2 | In distribution |
| 220225410E | Size: 4+ | In distribution |
| IB220906 | Size: 6 | In distribution |
| 200221946E | Height 15 mm | In distribution |
| 220225414E | Height 14 mm | In distribution |
| 200221944E | Size: 4 | In distribution |
| IB224314 | Size 3+ | In distribution |
| IB203308 | Size: 3 | In distribution |
| IB224415 | Size 4 | In distribution |
| 220224417E | Height 17 mm | In distribution |
| 220224415E | Size: 4 | In distribution |
| 220225515E | Height 15 mm | In distribution |
| 200014902 | Outer Diameter 16 mm | In distribution |
| IB205416 | Size: 4+ | In distribution |
| IB282904 | Size: 4 | In distribution |
| IB220902 | Size: 2 | In distribution |
| IB225509 | Size 5 | In distribution |
| 220224314E | Size: 3+ | In distribution |
| 200224314E | Height 14 mm | In distribution |
| IB220905 | Size: 5 | In distribution |
| 220223216E | Size: 2+ | In distribution |
| 200013901 | Outer Diameter 14 mm | In distribution |
| 220220903 | Size: 3 | In distribution |
| 220223208E | Size: 2+ | In distribution |
| 200221922E | Size: 2 | In distribution |
| IB204310 | Size: 3+ | In distribution |
| 220224413E | Height 13 mm | In distribution |
| IB225412 | Height 12 mm | In distribution |
| 220224411E | Size: 4 | In distribution |
| 200222906 | Right | In distribution |
| IB205513 | Size: 5 | In distribution |
| 220226514E | Height 14 mm | In distribution |
| 220222206E | Size: 2 | In distribution |
| 220223314E | Size: 3 | In distribution |
| 220222903 | Size: 3 Long | In distribution |
| 220224318E | Height 18 mm | In distribution |
| 220223318E | Height 18 mm | In distribution |
| 200221934E | Height 12 mm | In distribution |
| 200226510E | Height 10 mm | In distribution |
| IB203214 | Size: 2+ | In distribution |
| 200011902 | Outer Diameter 16 mm | In distribution |
| IB223210 | Height 10 mm | In distribution |
| 200013904 | Outer Diameter 12 mm | In distribution |
| 200013903 | Outer Diameter 18 mm | In distribution |
| 200226514E | Height 14 mm | In distribution |
| 200221924E | Height 11 mm | In distribution |
| 200347902 | Length 14 mm | In distribution |
| 200222902 | Right | In distribution |
| 200010901 | Outer Diameter 14 mm | In distribution |
| IB272902 | Size: 2 | In distribution |
| IB204314 | Height 14 mm | In distribution |
| 220226615E | Size: 6 | In distribution |
| 220224310E | Height 10 mm | In distribution |
| 220223214E | Height 14 mm | In distribution |
| 200009902 | Outer Diameter 18 mm | In distribution |
| IB204413 | Size: 4 | In distribution |
| 220224419E | Height 19 mm | In distribution |
| IB225416 | Size 4+ | In distribution |
| 200222904 | Size: 4 | In distribution |
| 220222212E | Size: 2 | In distribution |
| 200011901 | Outer Diameter 14 mm | In distribution |
| IB206609 | Height 9 mm | In distribution |
| IB224310 | Height 10 mm | In distribution |
| 200224310E | Size: 3+ | In distribution |
| 220222106E | Height 6 mm | In distribution |
| 200420001 | Small | In distribution |
| IB203210 | Size: 2+ | In distribution |
| 200347901 | Length 10 mm | In distribution |
| 220220906 | Size: 6 | In distribution |
| 200550005 | Size: 5 | In distribution |
| IB225511 | Size 5 | In distribution |
| 200221930E | Size: 3 | In distribution |
| 200221932E | Size: 3 | In distribution |
| IB224316 | Size 3+ | In distribution |
| IB224411 | Size 4 | In distribution |
| 220220905 | Size: 5 | In distribution |
| 200221956E | Size: 5 | In distribution |
| 200014903 | Outer Diameter 18 mm | In distribution |
| 220226520E | Size: 5+ | In distribution |
| 220225513E | Height 13 mm | In distribution |
| 200221964E | Size: 6 | In distribution |
| 200010902 | Outer Diameter 16 mm | In distribution |
| IB205511 | Size: 5 | In distribution |
| IB206516 | Size: 5+ | In distribution |
| IB206514 | Height 14 mm | In distribution |
| IB272903 | Size: 3 | In distribution |
| 200225410E | Height 10 mm | In distribution |
| 200014904 | Outer Diameter 4.8 mm | In distribution |
| 200012901 | Outer Diameter 14 mm | In distribution |
| 220226611E | Size: 6 | In distribution |
| 220224320E | Size: 3+ | In distribution |
| 220222210E | Size: 2 | In distribution |
| IB226516 | Height 16 mm | In distribution |
| 220222114E | Size: 1+ | In distribution |
| IB203312 | Height 12 mm | In distribution |
| 220252905 | Size: 5 Long | In distribution |
| 200221952E | Height 11 mm | In distribution |
| 220226512E | Height 12 mm | In distribution |
| 200221966E | Size: 6 | In distribution |
| IB206512 | Height 12 mm | In distribution |
| 220223218E | Height 18 mm | In distribution |
| IB272906 | Size: 6 | In distribution |
| 220222902 | 2 Long | In distribution |
| IB225515 | Height 15 mm | In distribution |
| IB223214 | Size 2+ | In distribution |
| 220220904 | Size: 4 | In distribution |
| IB226514 | Size 5+ | In distribution |
| 200252904 | Left | In distribution |
| IB223310 | Height 10 mm | In distribution |
| IB226512 | Height 12 mm | In distribution |
| 220226518E | Size: 5+ | In distribution |
| 200224312E | Height 12 mm | In distribution |
| IB282905 | Size: 5 | In distribution |
| 200221954E | Height 13 mm | In distribution |
| 200252906 | Left | In distribution |
| 200223215E | Height 15 mm | In distribution |
| IB205515 | Size: 5 | In distribution |
| 220225509E | Size: 5 | In distribution |
| 200221942E | Size: 4 | In distribution |
| IB222206 | Height 6 mm | In distribution |
| IB223308 | Height 8 mm | In distribution |
| 220222905 | Size: 5 Long | In distribution |
| 220222112E | Height 12 mm | In distribution |
| 220222904 | Size: 4 Long | In distribution |
| IB223208 | Height 8 mm | In distribution |
| IB226613 | Size 6 | In distribution |
| 220222214E | Height 14 mm | In distribution |
| 200221950E | Height 9 mm | In distribution |
| 200550003 | Size: 3 | In distribution |
| 220226510E | Size: 5+ | In distribution |
| IB225414 | Height 14 mm | In distribution |
| IB203314 | Size: 3 | In distribution |
| IB272905 | Size: 5 | In distribution |
| IB225513 | Size 5 | In distribution |
| 200221962E | Height 11 mm | In distribution |
| 220223308E | Size: 3 | In distribution |
| 220226609E | Size: 6 | In distribution |
| IB204312 | Height 12 mm | In distribution |
| IB204409 | Height 9 mm | In distribution |
| 200222905 | Right | In distribution |
| 200014901 | Outer Diameter 14 mm | In distribution |
| 220225412E | Size: 4+ | In distribution |
| IB206510 | Size: 5+ | In distribution |
| IB206613 | Height 13 mm | In distribution |
| IB203212 | Size: 2+ | In distribution |
| IB225410 | Size 4+ | In distribution |
| IB226611 | Size 6 | In distribution |
| 220225517E | Size: 5 | In distribution |
| 200252905 | Size: 5 | In distribution |
| 200012904 | Outer Diameter 12 mm | In distribution |
| 200225416E | Size: 4+ | In distribution |
| IB223212 | Size 2+ | In distribution |
| 220220901 | Size: 1 | In distribution |
| IB203208 | Size: 2+ | In distribution |
| 220224409E | Size: 4 | In distribution |
| IB203310 | Size: 3 | In distribution |
| 220226516E | Height 16 mm | In distribution |
| 220220902 | Size: 2 | In distribution |
| IB204316 | Height 16 mm | In distribution |
| IB282902 | Size: 2 | In distribution |
| 200012902 | Outer Diameter 16 mm | In distribution |
| 220222108E | Size: 1+ | In distribution |
| IB222212 | Height 12 mm | In distribution |
| 200223209E | Height 9 mm | In distribution |
| IB204411 | Height 11 mm | In distribution |
| 200011904 | Outer Diameter 12 mm | In distribution |
| 200010903 | Outer Diameter 18 mm | In distribution |
| IB220903 | Size: 3 | In distribution |
| 200252902 | Size: 2 | In distribution |
| 220223212E | Height 12 mm | In distribution |
| 200013902 | Outer Diameter 16 mm | In distribution |
| IB226510 | Height 10 mm | In distribution |
| 220224312E | Size: 3+ | In distribution |
| IB226615 | Height 15 mm | In distribution |
| 220222110E | Size: 1+ | In distribution |
| IB205509 | Size: 5 | In distribution |
| 220223316E | Height 16 mm | In distribution |
| 200221940E | Height 9 mm | In distribution |
| 220222116E | Size: 1+ | In distribution |
| 200550002 | Size: 2 | In distribution |
| IB222210 | Size 2 | In distribution |
| 220222216E | Height 16 mm | In distribution |
| 200221926E | Size: 2 | In distribution |
| IB272904 | Size: 4 | In distribution |
| IB204415 | Height 15 mm | In distribution |
| 220252902 | Size: 2 Long | In distribution |
| IB205412 | Size: 4+ | In distribution |
| IB205414 | Height 14 mm | In distribution |
| 220223310E | Height 10 mm | In distribution |
| 200220905 | Size: 5 | Withdrawn |
| 200220902 | Size: 2 | Withdrawn |
| 200220903 | Size: 3 | Withdrawn |
| 200220906 | Size: 6 | Withdrawn |
| 200220904 | Size: 4 | Withdrawn |
| 200347902 | Length 14 mm | Withdrawn |
| 200347901 | Length 10 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex 3D Total Ankle Replacement System | Paragon 28 | 658 |
| Vantage | Exactech, Inc. | 362 |
| Cadence™ | Ascension Orthopedics, Inc. | 248 |
| Cadence Total Ankle System | Smith & Nephew, Inc. | 246 |
| Hintermann Series H2 | DT Medtech LLC | 225 |
| Infinity | Wright Medical Technology, Inc. | 220 |
| Incompass Total Ankle System | Wright Medical Technology, Inc. | 213 |
| Invision | Wright Medical Technology, Inc. | 186 |
| Kinos Axiom Instrumentation | restor3d, inc. | 169 |
| Quantum | In2Bones SAS | 157 |
| Hintermann Series H2 | Vilex LLC | 153 |
| Trabecular Metal® | Zimmer, Inc. | 145 |
Showing 12 of 53. All products under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Wright Medical Technology, Inc. | 510(k) number | 2022-09-30 | Class II | Device Design | The tibial tray lock detail is oversized (larger than specification). | 1 unit | 2026-08-21 |
| Wright Medical Technology, Inc. | 510(k) number | 2022-09-30 | Class II | Device Design | The tibial tray lock detail is oversized (larger than specification). | 1 unit | 2026-08-21 |
| Wright Medical Technology, Inc. | UDI-DI | 2021-11-04 | Class II | Nonconforming Material/Component | The package contents and package labeling do not match. | 0 (2 Quarantined) | 2023-01-06 |
| Wright Medical Technology, Inc. | UDI-DI | 2021-11-04 | Class II | Nonconforming Material/Component | The package contents and package labeling do not match. | 2 units | 2023-01-06 |
| Wright Medical Technology, Inc. | 510(k) number | 2020-04-09 | Class II | Nonconforming Material/Component | One lot of INBONE Tibial Trays is missing the plasma coating. | 22 units | 2020-11-02 |
| Wright Medical Technology, Inc. | 510(k) number | 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 65 units | 2020-11-03 |
Recalls
3 of these are 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 |
|---|---|---|---|---|
| 2024-03-06 | Class II | Process change control | Stryker has identified an issue that impacts specific lots of Infinity” Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing | 47 units |
| 2023-06-13 | Class II | Process control | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. | 106 devices |
| 2022-06-02 | Class II | Nonconforming Material/Component | The instrument is incorrectly color coded. | 35 units |
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.