Home › Device types › JDR
Staple, Fixation, Bone
FDA product code JDR · Class 2 · Orthopedic
0
Registered devices
2,692
Adverse events
37
Recalls
233
510(k) clearances
Devices with this code
NeoSpan — In2Bones USA, LLCJUGGERLOC 5MM SLOTTED REAMER — Biomet Orthopedics, LLCLapiplasty SpeedPlate — Treace Medical Concepts, Inc.Compression Staple System — TORNIER, INC.Super Staple™ Classic — METRIC MEDICAL DEVICES, INC.Inion Hexalon instrument — Inion OySpeed Triad — Synthes GmbHDynaBridge — FUSION ORTHOPEDICS, LLCOSStaple — Biomedical Enterprises, Inc.Memory Staple — Wishbone Medical, Inc.Mainstay — STRYKER CORPORATIONEasyFuse™ — WRIGHT MEDICAL TECHNOLOGY, INC.SOLUSTAPLE — NEWDEALArthrex® — ARTHREX, INC.Lapiplasty SpeedPlate — Treace Medical Concepts, Inc.UNI-CLIP — NEWDEALArcus Staple System — Medartis Inc.EasyFuse™ — WRIGHT MEDICAL TECHNOLOGY, INC.TruTrack Memory Staple System — Intelivation, LLCElastic Staples — Trimed, INC.Stapix Superelastic Nitinol Staple System — Restore Surgical LLCDynaBridge — FUSION ORTHOPEDICS, LLCDynaBridge — FUSION ORTHOPEDICS, LLCZ-Staple — Z-Medical GmbH + Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-15 | F & A Foundation | Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. |
| 2026-05-11 | In2bones USA, LLC | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant |
| 2022-09-27 | Synthes (USA) Products LLC | The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant |
| 2022-08-30 | Synthes (USA) Products LLC | Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tis |
| 2022-03-10 | Wright Medical Technology, Inc. | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. |
| 2022-02-14 | Biomet, Inc. | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio |
| 2022-02-14 | Biomet, Inc. | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infectio |
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