{ "code": "KWS", "deviceName": "Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented", "deviceClass": "II", "regulationNumber": "888.3660", "panel": "Orthopedic", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 191, "last12Months": 4 }, "adverseEvents": { "total": 6263, "last12Months": 1501 }, "reviewDays": { "median": 98, "sampleSize": 191 }, "recalls": { "total": 152, "recent": [ { "resNumber": "Z-1769-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Tornier, Inc.", "firmAsPublished": "Tornier, Inc", "reason": "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.", "initiated": "2026-03-05" }, { "resNumber": "Z-1458-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Encore Medical, Lp", "firmAsPublished": "Encore Medical, LP", "reason": "Knee and Humeral socket implants contain incorrect labeling.", "initiated": "2026-01-15" }, { "resNumber": "Z-1237-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Tornier, Inc.", "firmAsPublished": "Tornier, Inc", "reason": "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.", "initiated": "2025-12-19" }, { "resNumber": "Z-2546-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Encore Medical, Lp", "firmAsPublished": "Encore Medical, LP", "reason": "Their is a potential that the reamer may kick or bind up during or immediately prior to use.", "initiated": "2025-07-18" }, { "resNumber": "Z-2547-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Encore Medical, Lp", "firmAsPublished": "Encore Medical, LP", "reason": "Their is a potential that the reamer may kick or bind up during or immediately prior to use.", "initiated": "2025-07-18" } ] }, "recentClearances": [ { "kNumber": "K260721", "deviceName": "Tornier Perform Advanced Glenoid", "applicant": "Tornier, Inc.", "company": "Tornier, Inc.", "decisionDate": "2026-07-22", "dateReceived": "2026-03-05" }, { "kNumber": "K254084", "deviceName": "AETOS Shoulder System - CONCELOC Glenoids", "applicant": "Smith & Nephew, Inc.", "company": "Smith & Nephew, Inc.", "decisionDate": "2026-04-06", "dateReceived": "2025-12-18" }, { "kNumber": "K252418", "deviceName": "Catalyst F1x Shoulder System", "applicant": "Catalyst Orthoscience, Inc.", "company": "Catalyst Orthoscience, Inc.", "decisionDate": "2025-11-06", "dateReceived": "2025-08-01" }, { "kNumber": "K252416", "deviceName": "AETOS Shoulder System Meta Humeral Prosthesis Size 0", "applicant": "Smith & Nephew, Inc.", "company": "Smith & Nephew, Inc.", "decisionDate": "2025-10-29", "dateReceived": "2025-08-01" }, { "kNumber": "K241292", "deviceName": "MyShoulder Planner (5.3SSWPL)", "applicant": "Medacta International S.A.", "company": "Medacta International S.A.", "decisionDate": "2025-01-30", "dateReceived": "2024-05-08" }, { "kNumber": "K241878", "deviceName": "Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)", "applicant": "Stryker Corporation (Tornier, Inc.)", "company": "Stryker Corporation (Tornier, Inc.)", "decisionDate": "2024-12-06", "dateReceived": "2024-06-28" }, { "kNumber": "K241609", "deviceName": "Tornier Humeral Reconstruction System (Tornier HRS)", "applicant": "Stryker Corporation (Tornier, Inc.)", "company": "Stryker Corporation (Tornier, Inc.)", "decisionDate": "2024-09-10", "dateReceived": "2024-06-05" }, { "kNumber": "K230513", "deviceName": "Arthrex Univers Apex OptiFit Humeral Stem", "applicant": "Arthrex, Inc.", "company": "Arthrex, Inc.", "decisionDate": "2023-09-26", "dateReceived": "2023-02-24" }, { "kNumber": "K222592", "deviceName": "AltiVate® Anatomic Shoulder AG e+™ with Markers", "applicant": "Encore Medical L.P.", "company": "Encore Medical, L.P. Dba Djo Surgical", "decisionDate": "2023-06-23", "dateReceived": "2022-08-26" }, { "kNumber": "K230572", "deviceName": "AETOS Shoulder System", "applicant": "Smith & Nephew, Inc.", "company": "Smith & Nephew, Inc.", "decisionDate": "2023-06-07", "dateReceived": "2023-03-01" } ], "topApplicants": [ { "name": "Arthrex, Inc.", "count": 15 }, { "name": "Tornier", "count": 12 }, { "name": "Tornier, Inc.", "count": 12 }, { "name": "Smith & Nephew, Inc.", "count": 11 }, { "name": "DePuy Orthopaedics, Inc.", "count": 9 } ], "topCompanies": [ { "name": "Tornier, Inc.", "count": 24, "spellings": 2 }, { "name": "Arthrex, Inc.", "count": 15, "spellings": 1 }, { "name": "Smith & Nephew, Inc.", "count": 11, "spellings": 1 }, { "name": "DePuy Orthopaedics, Inc.", "count": 9, "spellings": 1 }, { "name": "Encore Medical, L.P. Dba Djo Surgical", "count": 9, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 94, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 111, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 114, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 117, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 179, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 171, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 124, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 157, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 127, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 163, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 170, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 235, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 208, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 174, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 201, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 148, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 200, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 162, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 141, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 151, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 169, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 165, "expectedLow": 78.41385249226713, "expectedHigh": 221.46483541425138, "isSufficient": true }, { "month": "2025-02-01", "observed": 172, "expectedLow": 72.5957492280707, "expectedHigh": 196.70396417214775, "isSufficient": true }, { "month": "2025-03-01", "observed": 177, "expectedLow": 92.92412411942693, "expectedHigh": 235.39441642959622, "isSufficient": true }, { "month": "2025-04-01", "observed": 195, "expectedLow": 112.31036288738622, "expectedHigh": 234.26268333185362, "isSufficient": true }, { "month": "2025-05-01", "observed": 236, "expectedLow": 114.91197873933858, "expectedHigh": 221.05899128704573, "isSufficient": true }, { "month": "2025-06-01", "observed": 175, "expectedLow": 123.14407941971436, "expectedHigh": 268.7805047278002, "isSufficient": true }, { "month": "2025-07-01", "observed": 205, "expectedLow": 188.22968976238164, "expectedHigh": 404.7518596335624, "isSufficient": true }, { "month": "2025-08-01", "observed": 176, "expectedLow": 123.03528320788311, "expectedHigh": 285.16195163231407, "isSufficient": true }, { "month": "2025-09-01", "observed": 161, "expectedLow": 119.38533884256644, "expectedHigh": 291.5072772997846, "isSufficient": true }, { "month": "2025-10-01", "observed": 201, "expectedLow": 101.80148514193513, "expectedHigh": 278.94209707320215, "isSufficient": true }, { "month": "2025-11-01", "observed": 168, "expectedLow": 101.03988007955327, "expectedHigh": 248.3885335241004, "isSufficient": true }, { "month": "2025-12-01", "observed": 193, "expectedLow": 112.08530498589128, "expectedHigh": 271.05414469847085, "isSufficient": true }, { "month": "2026-01-01", "observed": 226, "expectedLow": 131.08490833423008, "expectedHigh": 312.51606790291333, "isSufficient": true }, { "month": "2026-02-01", "observed": 223, "expectedLow": 112.27548835638497, "expectedHigh": 266.17449794189224, "isSufficient": true }, { "month": "2026-03-01", "observed": 217, "expectedLow": 135.42969704897632, "expectedHigh": 301.11198944701806, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "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).", "severity": 75, "factors": [ { "kind": "recall", "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-1769-2026", "Z-1458-2026", "Z-1237-2026" ], "severity": 75 } ], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3AKWS" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKWS" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKWS" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKWS" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKWS" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKWS" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKWS" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.736Z" }