FDA product code · Orthopedic
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Product code JDI covers Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II device regulated under 21 CFR 888.3350. FDA has cleared 564 devices in this code, 2 of them in the last 12 months. Median review time across the 564 most recent decisions is 87 days. openFDA lists 255 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3350
- Review panel
- Orthopedic
- Clearances
- 564
What is happening in JDI right now?
JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0153-2026, Z-2640-2025). The code is crowded, scoring 61 of 100 — 111 companies hold a clearance here and 2 arrived in the last 12 months (JDI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0153-2026, Z-2640-2025 |
| Crowding | Context | JDI:crowding |
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 JDI?
FDA has cleared 564 devices under product code JDI since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics |
How long does FDA review take for JDI?
The median FDA review time for JDI is 87 days, measured across the 564 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 JDI?
openFDA lists 255 recall records against product code JDI. A recall record covers one firm's corrective action and may span many device lots.
Z-0153-2026Open, ClassifiedBiopro, Inc.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Z-2640-2025Open, ClassifiedHowmedica Osteonics Corp.
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Z-2423-2025Open, ClassifiedOnkos Surgical, Inc.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Z-2424-2025Open, ClassifiedOnkos Surgical, Inc.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Z-2425-2025Open, ClassifiedOnkos Surgical, Inc.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Showing the 5 most recently initiated of 255. 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 JDI?
MAUDE holds 5,036 adverse-event reports naming product code JDI, 1,023 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 JDI unusual?
One month sits above JDI's own expected range: 1 February 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 111 | Insufficient history | No expected range — too little history | |
| 123 | Insufficient history | No expected range — too little history | |
| 129 | Insufficient history | No expected range — too little history | |
| 123 | Insufficient history | No expected range — too little history | |
| 131 | Insufficient history | No expected range — too little history | |
| 141 | Insufficient history | No expected range — too little history | |
| 140 | Insufficient history | No expected range — too little history | |
| 126 | Insufficient history | No expected range — too little history | |
| 92 | Insufficient history | No expected range — too little history | |
| 116 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 123 | Insufficient history | No expected range — too little history | |
| 156 | Insufficient history | No expected range — too little history | |
| 239 | Insufficient history | No expected range — too little history | |
| 166 | Insufficient history | No expected range — too little history | |
| 154 | Insufficient history | No expected range — too little history | |
| 162 | Insufficient history | No expected range — too little history | |
| 179 | Insufficient history | No expected range — too little history | |
| 148 | Insufficient history | No expected range — too little history | |
| 110 | Insufficient history | No expected range — too little history | |
| 148 | Insufficient history | No expected range — too little history | |
| 114 | 66–201 | Within expected (66–201) | |
| 177 | 53–169 | Above expected (53–169) | |
| 108 | 75–218 | Within expected (75–218) | |
| 119 | 64–216 | Within expected (64–216) | |
| 118 | 54–199 | Within expected (54–199) | |
| 146 | 69–186 | Within expected (69–186) | |
| 168 | 123–294 | Within expected (123–294) | |
| 88 | 81–216 | Within expected (81–216) | |
| 162 | 57–218 | Within expected (57–218) | |
| 129 | 68–218 | Within expected (68–218) | |
| 128 | 56–193 | Within expected (56–193) | |
| 139 | 66–214 | Within expected (66–214) | |
| 138 | 75–247 | Within expected (75–247) | |
| 126 | 57–206 | Within expected (57–206) | |
| 136 | 94–188 | Within expected (94–188) |
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 JDI.
What are the predicate devices in JDI?
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 JDI?
Across the 564 most recent decisions, these applicants filed most often in JDI.
| Applicant | Recent clearances |
|---|---|
| Biomet, Inc. | 51 |
| Depuy, Inc. | 45 |
| Howmedica Corp. | 35 |
| Osteonics Corp. | 29 |
| Zimmer, Inc. | 27 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JDI files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Howmedica Corp. | 43 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JDI
Get an email the morning anything changes in JDI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.