FDA product code · Orthopedic
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Product code KWS covers Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II device regulated under 21 CFR 888.3660. FDA has cleared 191 devices in this code, 4 of them in the last 12 months. Median review time across the 191 most recent decisions is 98 days. openFDA lists 152 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3660
- Review panel
- Orthopedic
- Clearances
- 191
What is happening in KWS right now?
KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented) has one finding. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1769-2026, Z-1458-2026, Z-1237-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1769-2026, Z-1458-2026, Z-1237-2026 |
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 KWS?
FDA has cleared 191 devices under product code KWS since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | |
| K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | |
| K252418 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | |
| K241292 | MyShoulder Planner (5.3SSWPL) | Medacta International S.A. | |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | |
| K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | |
| K230572 | AETOS Shoulder System | Smith & Nephew, Inc. |
How long does FDA review take for KWS?
The median FDA review time for KWS is 98 days, measured across the 191 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 KWS?
openFDA lists 152 recall records against product code KWS. A recall record covers one firm's corrective action and may span many device lots.
Z-1769-2026Open, ClassifiedTornier, Inc.
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
Z-1458-2026Open, ClassifiedEncore Medical, Lp
Knee and Humeral socket implants contain incorrect labeling.
Z-1237-2026Open, ClassifiedTornier, Inc.
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
Z-2546-2025Open, ClassifiedEncore Medical, Lp
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Z-2547-2025Open, ClassifiedEncore Medical, Lp
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Showing the 5 most recently initiated of 152. 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 KWS?
MAUDE holds 6,263 adverse-event reports naming product code KWS, 1,501 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 KWS unusual?
One month sits above KWS's own expected range: 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 94 | Insufficient history | No expected range — too little history | |
| 111 | Insufficient history | No expected range — too little history | |
| 114 | Insufficient history | No expected range — too little history | |
| 117 | Insufficient history | No expected range — too little history | |
| 179 | Insufficient history | No expected range — too little history | |
| 171 | Insufficient history | No expected range — too little history | |
| 124 | Insufficient history | No expected range — too little history | |
| 157 | Insufficient history | No expected range — too little history | |
| 127 | Insufficient history | No expected range — too little history | |
| 163 | Insufficient history | No expected range — too little history | |
| 170 | Insufficient history | No expected range — too little history | |
| 235 | Insufficient history | No expected range — too little history | |
| 208 | Insufficient history | No expected range — too little history | |
| 174 | Insufficient history | No expected range — too little history | |
| 201 | Insufficient history | No expected range — too little history | |
| 148 | Insufficient history | No expected range — too little history | |
| 200 | Insufficient history | No expected range — too little history | |
| 162 | Insufficient history | No expected range — too little history | |
| 141 | Insufficient history | No expected range — too little history | |
| 151 | Insufficient history | No expected range — too little history | |
| 169 | Insufficient history | No expected range — too little history | |
| 165 | 78–221 | Within expected (78–221) | |
| 172 | 73–197 | Within expected (73–197) | |
| 177 | 93–235 | Within expected (93–235) | |
| 195 | 112–234 | Within expected (112–234) | |
| 236 | 115–221 | Above expected (115–221) | |
| 175 | 123–269 | Within expected (123–269) | |
| 205 | 188–405 | Within expected (188–405) | |
| 176 | 123–285 | Within expected (123–285) | |
| 161 | 119–292 | Within expected (119–292) | |
| 201 | 102–279 | Within expected (102–279) | |
| 168 | 101–248 | Within expected (101–248) | |
| 193 | 112–271 | Within expected (112–271) | |
| 226 | 131–313 | Within expected (131–313) | |
| 223 | 112–266 | Within expected (112–266) | |
| 217 | 135–301 | Within expected (135–301) |
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 KWS.
What are the predicate devices in KWS?
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 KWS?
Across the 191 most recent decisions, these applicants filed most often in KWS.
| Applicant | Recent clearances |
|---|---|
| Arthrex, Inc. | 15 |
| Tornier | 12 |
| Tornier, Inc. | 12 |
| Smith & Nephew, Inc. | 11 |
| DePuy Orthopaedics, Inc. | 9 |
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 KWS 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 |
|---|---|---|
| Tornier, Inc. | 24 | 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 KWS
Get an email the morning anything changes in KWS — 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.