Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

ECHELON

Model 71340822 · Smith & Nephew, Inc. · DI 03596010432292

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358

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.

12342019-01: 0 reports for this device; peer average 3.59/device2019-02: 0 reports for this device; peer average 2.98/device2019-03: 0 reports for this device; peer average 3.33/device2019-04: 0 reports for this device; peer average 3.1/device2019-05: 0 reports for this device; peer average 2.4/device2019-06: 0 reports for this device; peer average 2.04/device2019-07: 0 reports for this device; peer average 2.12/device2019-08: 0 reports for this device; peer average 2.33/device2019-09: 0 reports for this device; peer average 2.81/device2019-10: 0 reports for this device; peer average 2.98/device2019-11: 0 reports for this device; peer average 2.39/device2019-12: 0 reports for this device; peer average 2.76/device2020-01: 0 reports for this device; peer average 3.15/device2020-02: 0 reports for this device; peer average 2.86/device2020-03: 0 reports for this device; peer average 3.68/device2020-04: 0 reports for this device; peer average 2.48/device2020-05: 0 reports for this device; peer average 2.49/device2020-06: 0 reports for this device; peer average 2.26/device2020-07: 0 reports for this device; peer average 2.79/device2020-08: 0 reports for this device; peer average 2.19/device2020-09: 0 reports for this device; peer average 2.77/device2020-10: 0 reports for this device; peer average 2.79/device2020-11: 0 reports for this device; peer average 2.55/device2020-12: 0 reports for this device; peer average 2.52/device2021-01: 0 reports for this device; peer average 2.69/device2021-02: 0 reports for this device; peer average 2.2/device2021-03: 0 reports for this device; peer average 2.21/device2021-04: 0 reports for this device; peer average 2.23/device2021-05: 0 reports for this device; peer average 2.13/device2021-06: 0 reports for this device; peer average 2.78/device2021-07: 0 reports for this device; peer average 2.48/device2021-08: 0 reports for this device; peer average 2.42/device2021-09: 0 reports for this device; peer average 2.49/device2021-10: 0 reports for this device; peer average 2.28/device2021-11: 0 reports for this device; peer average 2.29/device2021-12: 0 reports for this device; peer average 2.57/device2022-01: 0 reports for this device; peer average 2.22/device2022-02: 0 reports for this device; peer average 2.25/device2022-03: 0 reports for this device; peer average 2.34/device2022-04: 0 reports for this device; peer average 2.34/device2022-05: 0 reports for this device; peer average 2.17/device2022-06: 0 reports for this device; peer average 2.46/device2022-07: 0 reports for this device; peer average 2.22/device2022-08: 0 reports for this device; peer average 2.33/device2022-09: 0 reports for this device; peer average 2.27/device2022-10: 0 reports for this device; peer average 2.27/device2022-11: 0 reports for this device; peer average 2.37/device2022-12: 0 reports for this device; peer average 2.38/device2023-01: 0 reports for this device; peer average 2.28/device2023-02: 0 reports for this device; peer average 2.28/device2023-03: 0 reports for this device; peer average 2.58/device2023-04: 0 reports for this device; peer average 2.39/device2023-05: 0 reports for this device; peer average 2.37/device2023-06: 0 reports for this device; peer average 2.41/device2023-07: 0 reports for this device; peer average 2.21/device2023-08: 0 reports for this device; peer average 2.13/device2023-09: 0 reports for this device; peer average 2.1/device2023-10: 0 reports for this device; peer average 1.75/device2023-11: 0 reports for this device; peer average 1.69/device2023-12: 0 reports for this device; peer average 1.79/device2024-01: 0 reports for this device; peer average 1.81/device2024-02: 0 reports for this device; peer average 2.15/device2024-03: 0 reports for this device; peer average 2.05/device2024-04: 0 reports for this device; peer average 1.82/device2024-05: 0 reports for this device; peer average 2.16/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.81/device2024-08: 0 reports for this device; peer average 1.92/device2024-09: 0 reports for this device; peer average 2.17/device2024-10: 0 reports for this device; peer average 1.85/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 0 reports for this device; peer average 1.6/device2025-01: 0 reports for this device; peer average 1.95/device2025-02: 0 reports for this device; peer average 1.54/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.84/device2025-05: 0 reports for this device; peer average 1.72/device2025-06: 0 reports for this device; peer average 1.86/device2025-07: 0 reports for this device; peer average 1.85/device2025-08: 0 reports for this device; peer average 1.71/device2025-09: 0 reports for this device; peer average 1.84/device2025-10: 0 reports for this device; peer average 1.75/device2025-11: 0 reports for this device; peer average 1.86/device2025-12: 0 reports for this device; peer average 1.94/device2026-01: 0 reports for this device; peer average 2.06/device2026-02: 0 reports for this device; peer average 1.66/device2026-03: 0 reports for this device; peer average 2.07/device2026-04: 0 reports for this device; peer average 1.89/device2026-05: 0 reports for this device; peer average 1.77/device2026-06: 0 reports for this device; peer average 1.78/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.59
2019-0202.98
2019-0303.33
2019-0403.1
2019-0502.4
2019-0602.04
2019-0702.12
2019-0802.33
2019-0902.81
2019-1002.98
2019-1102.39
2019-1202.76
2020-0103.15
2020-0202.86
2020-0303.68
2020-0402.48
2020-0502.49
2020-0602.26
2020-0702.79
2020-0802.19
2020-0902.77
2020-1002.79
2020-1102.55
2020-1202.52
2021-0102.69
2021-0202.2
2021-0302.21
2021-0402.23
2021-0502.13
2021-0602.78
2021-0702.48
2021-0802.42
2021-0902.49
2021-1002.28
2021-1102.29
2021-1202.57
2022-0102.22
2022-0202.25
2022-0302.34
2022-0402.34
2022-0502.17
2022-0602.46
2022-0702.22
2022-0802.33
2022-0902.27
2022-1002.27
2022-1102.37
2022-1202.38
2023-0102.28
2023-0202.28
2023-0302.58
2023-0402.39
2023-0502.37
2023-0602.41
2023-0702.21
2023-0802.13
2023-0902.1
2023-1001.75
2023-1101.69
2023-1201.79
2024-0101.81
2024-0202.15
2024-0302.05
2024-0401.82
2024-0502.16
2024-0602
2024-0701.81
2024-0801.92
2024-0902.17
2024-1001.85
2024-1101.79
2024-1201.6
2025-0101.95
2025-0201.54
2025-0301.78
2025-0401.84
2025-0501.72
2025-0601.86
2025-0701.85
2025-0801.71
2025-0901.84
2025-1001.75
2025-1101.86
2025-1201.94
2026-0102.06
2026-0201.66
2026-0302.07
2026-0401.89
2026-0501.77
2026-0601.78
This device (reports/month)Average device in JDI, LPH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K963486 — cited as predicate by K191002, K211176, K220959, K240783

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
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • 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