FDA product code · Orthopedic
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product code JWH covers Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II device regulated under 21 CFR 888.3560. FDA has cleared 913 devices in this code, 9 of them in the last 12 months. Median review time across the 913 most recent decisions is 90 days. openFDA lists 983 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3560
- Review panel
- Orthopedic
- Clearances
- 913
What is happening in JWH right now?
JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2883-2026, Z-2700-2026, Z-2701-2026, Z-1459-2026, Z-1233-2026). The code is crowded, scoring 72 of 100 — 133 companies hold a clearance here and 9 arrived in the last 12 months (JWH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2883-2026, Z-2700-2026, Z-2701-2026, Z-1459-2026, Z-1233-2026 |
| Crowding | Context | JWH: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 JWH?
FDA has cleared 913 devices under product code JWH since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | |
| K261032 | NovoKnee (SteriKnee) | NovoSource | |
| K253793 | Materialise TKA Guide System | Materialise NV | |
| K252974 | EMPOWR Knee | Encore Medical L.P. | |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Depuy Ireland UC | |
| K253314 | Freedom Infinia Total Knee System | Maxx Orthopedics, Inc. | |
| K253144 | Freedom® Total Knee System Titan PCK Components | Maxx Orthopedics, Inc. | |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | United Orthopedic Corporation | |
| K251554 | Materialise TKA Guide System | Materialise NV |
How long does FDA review take for JWH?
The median FDA review time for JWH is 90 days, measured across the 913 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 JWH?
openFDA lists 983 recall records against product code JWH. A recall record covers one firm's corrective action and may span many device lots.
Z-2883-2026Open, ClassifiedUnited Orthopedic Corporation
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Z-2700-2026Open, ClassifiedEncore Medical, Lp
Due to packaging discrepancy with incorrect product size mixed up.
Z-2701-2026Open, ClassifiedEncore Medical, Lp
Due to packaging discrepancy with incorrect product size mixed up.
Z-1459-2026Open, ClassifiedEncore Medical, Lp
Knee and Humeral socket implants contain incorrect labeling.
Z-1233-2026Open, ClassifiedEncore Medical, Lp
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Showing the 5 most recently initiated of 983. 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 JWH?
MAUDE holds 28,318 adverse-event reports naming product code JWH, 5,080 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 JWH unusual?
Every month with enough history behind it falls inside JWH's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 667 | Insufficient history | No expected range — too little history | |
| 714 | Insufficient history | No expected range — too little history | |
| 858 | Insufficient history | No expected range — too little history | |
| 755 | Insufficient history | No expected range — too little history | |
| 761 | Insufficient history | No expected range — too little history | |
| 788 | Insufficient history | No expected range — too little history | |
| 611 | Insufficient history | No expected range — too little history | |
| 686 | Insufficient history | No expected range — too little history | |
| 585 | Insufficient history | No expected range — too little history | |
| 648 | Insufficient history | No expected range — too little history | |
| 732 | Insufficient history | No expected range — too little history | |
| 808 | Insufficient history | No expected range — too little history | |
| 901 | Insufficient history | No expected range — too little history | |
| 1,059 | Insufficient history | No expected range — too little history | |
| 973 | Insufficient history | No expected range — too little history | |
| 885 | Insufficient history | No expected range — too little history | |
| 999 | Insufficient history | No expected range — too little history | |
| 928 | Insufficient history | No expected range — too little history | |
| 1,030 | Insufficient history | No expected range — too little history | |
| 811 | Insufficient history | No expected range — too little history | |
| 1,054 | Insufficient history | No expected range — too little history | |
| 846 | 634–1,101 | Within expected (634–1,101) | |
| 789 | 588–914 | Within expected (588–914) | |
| 671 | 696–1,013 | Below expected (696–1,013) | |
| 713 | 630–1,025 | Within expected (630–1,025) | |
| 799 | 542–948 | Within expected (542–948) | |
| 844 | 597–982 | Within expected (597–982) | |
| 854 | 1,013–1,510 | Below expected (1,013–1,510) | |
| 648 | 600–1,126 | Within expected (600–1,126) | |
| 684 | 517–1,162 | Within expected (517–1,162) | |
| 646 | 438–1,138 | Within expected (438–1,138) | |
| 805 | 338–1,002 | Within expected (338–1,002) | |
| 748 | 423–1,158 | Within expected (423–1,158) | |
| 558 | 508–1,283 | Within expected (508–1,283) | |
| 513 | 306–1,040 | Within expected (306–1,040) | |
| 685 | 298–1,065 | Within expected (298–1,065) |
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 JWH.
What are the predicate devices in JWH?
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 JWH?
Across the 913 most recent decisions, these applicants filed most often in JWH.
| Applicant | Recent clearances |
|---|---|
| Zimmer, Inc. | 51 |
| Smith & Nephew, Inc. | 49 |
| Howmedica Corp. | 47 |
| Biomet, Inc. | 40 |
| Conformis, Inc. | 40 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JWH
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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.