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'POLARSTEM¿'

Model 75102242 · Smith & Nephew, Inc. · DI 00885556533697

KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390

LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222019-01: 0 reports for this device; peer average 2.17/device2019-02: 0 reports for this device; peer average 2.01/device2019-03: 0 reports for this device; peer average 2.2/device2019-04: 0 reports for this device; peer average 2.2/device2019-05: 0 reports for this device; peer average 1.81/device2019-06: 0 reports for this device; peer average 1.58/device2019-07: 0 reports for this device; peer average 1.56/device2019-08: 0 reports for this device; peer average 1.9/device2019-09: 0 reports for this device; peer average 1.8/device2019-10: 0 reports for this device; peer average 2.02/device2019-11: 0 reports for this device; peer average 1.82/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2.3/device2020-02: 0 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 2.47/device2020-04: 0 reports for this device; peer average 1.93/device2020-05: 0 reports for this device; peer average 1.8/device2020-06: 0 reports for this device; peer average 1.75/device2020-07: 0 reports for this device; peer average 2.16/device2020-08: 0 reports for this device; peer average 1.78/device2020-09: 0 reports for this device; peer average 2.13/device2020-10: 0 reports for this device; peer average 2.08/device2020-11: 0 reports for this device; peer average 1.92/device2020-12: 0 reports for this device; peer average 2.02/device2021-01: 0 reports for this device; peer average 2.06/device2021-02: 0 reports for this device; peer average 1.78/device2021-03: 0 reports for this device; peer average 1.79/device2021-04: 0 reports for this device; peer average 1.79/device2021-05: 0 reports for this device; peer average 1.75/device2021-06: 0 reports for this device; peer average 2.06/device2021-07: 0 reports for this device; peer average 2.05/device2021-08: 0 reports for this device; peer average 2.01/device2021-09: 0 reports for this device; peer average 2.21/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.79/device2021-12: 0 reports for this device; peer average 1.94/device2022-01: 0 reports for this device; peer average 1.81/device2022-02: 0 reports for this device; peer average 1.86/device2022-03: 0 reports for this device; peer average 1.89/device2022-04: 0 reports for this device; peer average 1.89/device2022-05: 0 reports for this device; peer average 2.01/device2022-06: 0 reports for this device; peer average 1.93/device2022-07: 0 reports for this device; peer average 1.89/device2022-08: 0 reports for this device; peer average 1.99/device2022-09: 0 reports for this device; peer average 2.05/device2022-10: 0 reports for this device; peer average 1.94/device2022-11: 0 reports for this device; peer average 2.03/device2022-12: 0 reports for this device; peer average 1.86/device2023-01: 0 reports for this device; peer average 2.22/device2023-02: 0 reports for this device; peer average 1.93/device2023-03: 0 reports for this device; peer average 1.99/device2023-04: 0 reports for this device; peer average 2.1/device2023-05: 0 reports for this device; peer average 1.98/device2023-06: 0 reports for this device; peer average 2.1/device2023-07: 0 reports for this device; peer average 2.07/device2023-08: 0 reports for this device; peer average 1.88/device2023-09: 0 reports for this device; peer average 1.93/device2023-10: 0 reports for this device; peer average 1.61/device2023-11: 0 reports for this device; peer average 1.57/device2023-12: 0 reports for this device; peer average 1.65/device2024-01: 0 reports for this device; peer average 1.68/device2024-02: 0 reports for this device; peer average 1.94/device2024-03: 0 reports for this device; peer average 1.96/device2024-04: 0 reports for this device; peer average 1.75/device2024-05: 0 reports for this device; peer average 2.16/device2024-06: 0 reports for this device; peer average 1.92/device2024-07: 0 reports for this device; peer average 1.66/device2024-08: 0 reports for this device; peer average 1.97/device2024-09: 0 reports for this device; peer average 1.95/device2024-10: 0 reports for this device; peer average 1.75/device2024-11: 0 reports for this device; peer average 1.67/device2024-12: 0 reports for this device; peer average 1.57/device2025-01: 0 reports for this device; peer average 1.84/device2025-02: 0 reports for this device; peer average 1.51/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.79/device2025-05: 0 reports for this device; peer average 1.65/device2025-06: 0 reports for this device; peer average 1.78/device2025-07: 0 reports for this device; peer average 1.77/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1.61/device2025-10: 0 reports for this device; peer average 1.68/device2025-11: 0 reports for this device; peer average 1.71/device2025-12: 0 reports for this device; peer average 1.8/device2026-01: 0 reports for this device; peer average 1.84/device2026-02: 0 reports for this device; peer average 1.61/device2026-03: 0 reports for this device; peer average 1.86/device2026-04: 0 reports for this device; peer average 1.82/device2026-05: 0 reports for this device; peer average 1.64/device2026-06: 0 reports for this device; peer average 1.7/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.17
2019-0202.01
2019-0302.2
2019-0402.2
2019-0501.81
2019-0601.58
2019-0701.56
2019-0801.9
2019-0901.8
2019-1002.02
2019-1101.82
2019-1202
2020-0102.3
2020-0202.04
2020-0302.47
2020-0401.93
2020-0501.8
2020-0601.75
2020-0702.16
2020-0801.78
2020-0902.13
2020-1002.08
2020-1101.92
2020-1202.02
2021-0102.06
2021-0201.78
2021-0301.79
2021-0401.79
2021-0501.75
2021-0602.06
2021-0702.05
2021-0802.01
2021-0902.21
2021-1002
2021-1101.79
2021-1201.94
2022-0101.81
2022-0201.86
2022-0301.89
2022-0401.89
2022-0502.01
2022-0601.93
2022-0701.89
2022-0801.99
2022-0902.05
2022-1001.94
2022-1102.03
2022-1201.86
2023-0102.22
2023-0201.93
2023-0301.99
2023-0402.1
2023-0501.98
2023-0602.1
2023-0702.07
2023-0801.88
2023-0901.93
2023-1001.61
2023-1101.57
2023-1201.65
2024-0101.68
2024-0201.94
2024-0301.96
2024-0401.75
2024-0502.16
2024-0601.92
2024-0701.66
2024-0801.97
2024-0901.95
2024-1001.75
2024-1101.67
2024-1201.57
2025-0101.84
2025-0201.51
2025-0301.78
2025-0401.79
2025-0501.65
2025-0601.78
2025-0701.77
2025-0801.67
2025-0901.61
2025-1001.68
2025-1101.71
2025-1201.8
2026-0101.84
2026-0201.61
2026-0301.86
2026-0401.82
2026-0501.64
2026-0601.7
This device (reports/month)Average device in KWY, LWJ, LZO, MEH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K143739 — cites (transitively): K130728 (d1), K052792 (d2) — cited as predicate by K211176, K211548, K212815, K240381

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
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  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations