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CHS

Model 71679002 · Smith & Nephew, Inc. · DI 03596010614926

JDO — Device, Fixation, Proximal Femoral, Implant · Class II · 21 CFR 888.3030

UDILibrary device dossier · generated 2026-09-15 · 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.

23562019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 2.33/device2020-02: 0 reports for this device; peer average 2.6/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 6/device2020-10: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 4/device040510110204050809101201020509110206110204050106
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-0501
2019-1001
2019-1102.33
2020-0202.6
2020-0402
2020-0501
2020-0801
2020-0906
2020-1001
2020-1201
2021-0101
2021-0201
2021-0502
2021-0901
2021-1101
2022-0203
2022-0601.5
2022-1102
2025-0201.5
2025-0401
2025-0502
2026-0101
2026-0604
This device (reports/month)Average device in JDO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K080434 — cited as predicate by K210837, K213126

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