FDA product code · Orthopedic
JDRStaple, Fixation, Bone
Product code JDR covers Staple, Fixation, Bone, a Class II device regulated under 21 CFR 888.3030. FDA has cleared 231 devices in this code. Median review time across the 231 most recent decisions is 90 days. openFDA lists 36 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3030
- Review panel
- Orthopedic
- Clearances
- 231
What is happening in JDR right now?
JDR (Staple, Fixation, Bone) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2355-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2355-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JDR?
FDA has cleared 231 devices under product code JDR since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250712 | Linkt Compression Staple System | Trax Surgical | |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | |
| K240212 | COGNiTiON Staple System | Ortho Solutions UK , Ltd. | |
| K232990 | ATOMIC Nitinol Fixation System | Rmr Ortho, LLC | |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. |
How long does FDA review take for JDR?
The median FDA review time for JDR is 90 days, measured across the 231 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JDR?
openFDA lists 36 recall records against product code JDR. A recall record covers one firm's corrective action and may span many device lots.
Z-2355-2026Open, ClassifiedIn2bones USA, LLC
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Z-0098-2023Open, ClassifiedSynthes (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 included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Z-0099-2023Open, ClassifiedSynthes (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 included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Z-0100-2023Open, ClassifiedSynthes (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 included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Z-0101-2023Open, ClassifiedSynthes (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 included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Showing the 5 most recently initiated of 36. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JDR?
MAUDE holds 704 adverse-event reports naming product code JDR, 240 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JDR unusual?
2 months sit above JDR's own expected range: 1 May 2025, 1 September 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 7 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 11 | 6–28 | Within expected (6–28) | |
| 8 | 4–23 | Within expected (4–23) | |
| 18 | 2–25 | Within expected (2–25) | |
| 22 | 3–27 | Within expected (3–27) | |
| 35 | 5–27 | Above expected (5–27) | |
| 12 | 6–39 | Within expected (6–39) | |
| 10 | 4–57 | Within expected (4–57) | |
| 11 | 0–39 | Within expected (0–39) | |
| 139 | 0–39 | Above expected (0–39) | |
| 11 | 0–125 | Within expected (0–125) | |
| 11 | 0–102 | Within expected (0–102) | |
| 25 | 0–104 | Within expected (0–104) | |
| 18 | 0–118 | Within expected (0–118) | |
| 14 | 0–95 | Within expected (0–95) | |
| 14 | 0–101 | Within expected (0–101) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in JDR.
What are the predicate devices in JDR?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JDR?
Across the 231 most recent decisions, these applicants filed most often in JDR.
| Applicant | Recent clearances |
|---|---|
| Mitek Surgical Products, Inc. | 16 |
| Acufex Microsurgical, Inc. | 9 |
| Depuy Mitek, A Johnson & Johnson Company | 7 |
| Biomedical Ent., Inc. | 6 |
| Arthrex, Inc. | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JDR
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.