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Accord

Model 71340014 · Smith & Nephew, Inc. · DI 03596010525321

JDQ — Cerclage, Fixation · Class II · 21 CFR 888.3010

UDILibrary device dossier · generated 2026-09-11 · 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.

23572019-01: 0 reports for this device; peer average 1.25/device2019-02: 0 reports for this device; peer average 1.25/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 2.38/device2019-06: 0 reports for this device; peer average 1.67/device2019-07: 0 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 3.17/device2019-10: 0 reports for this device; peer average 2.33/device2019-11: 0 reports for this device; peer average 2.75/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 3.33/device2020-02: 0 reports for this device; peer average 1.8/device2020-03: 0 reports for this device; peer average 1.8/device2020-04: 0 reports for this device; peer average 2.25/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 3.33/device2020-07: 0 reports for this device; peer average 2.67/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2.4/device2020-10: 0 reports for this device; peer average 2.67/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 3/device2021-03: 0 reports for this device; peer average 2.4/device2021-04: 0 reports for this device; peer average 4.33/device2021-05: 0 reports for this device; peer average 1.67/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 3.25/device2021-09: 0 reports for this device; peer average 5/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 3.33/device2021-12: 0 reports for this device; peer average 2.5/device2022-01: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 2.4/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1.4/device2022-07: 0 reports for this device; peer average 1.33/device2022-08: 0 reports for this device; peer average 2.75/device2022-09: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 6/device2022-11: 0 reports for this device; peer average 3.8/device2022-12: 0 reports for this device; peer average 3.5/device2023-01: 0 reports for this device; peer average 3.33/device2023-02: 0 reports for this device; peer average 4/device2023-03: 0 reports for this device; peer average 6.67/device2023-04: 0 reports for this device; peer average 2.93/device2023-05: 0 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 4/device2023-07: 0 reports for this device; peer average 2.86/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 4/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 2.83/device2024-05: 0 reports for this device; peer average 3/device2024-07: 0 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 1.5/device2024-09: 0 reports for this device; peer average 1.25/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2.33/device2024-12: 0 reports for this device; peer average 5/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 3.5/device2025-05: 0 reports for this device; peer average 6.4/device2025-06: 0 reports for this device; peer average 5/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 4.5/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.25/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 3.14/device2026-01: 0 reports for this device; peer average 2.5/device2026-02: 0 reports for this device; peer average 1.4/device2026-03: 0 reports for this device; peer average 1.75/device2026-04: 0 reports for this device; peer average 1.5/device2026-05: 0 reports for this device; peer average 5/device2026-06: 0 reports for this device; peer average 1.83/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.25
2019-0201.25
2019-0302
2019-0402.75
2019-0502.38
2019-0601.67
2019-0703.5
2019-0802.5
2019-0903.17
2019-1002.33
2019-1102.75
2019-1202
2020-0103.33
2020-0201.8
2020-0301.8
2020-0402.25
2020-0501.5
2020-0603.33
2020-0702.67
2020-0801
2020-0902.4
2020-1002.67
2020-1101.5
2020-1202
2021-0102
2021-0203
2021-0302.4
2021-0404.33
2021-0501.67
2021-0602.5
2021-0701
2021-0803.25
2021-0905
2021-1002.5
2021-1103.33
2021-1202.5
2022-0101.33
2022-0203
2022-0302.4
2022-0402
2022-0503
2022-0601.4
2022-0701.33
2022-0802.75
2022-0903
2022-1006
2022-1103.8
2022-1203.5
2023-0103.33
2023-0204
2023-0306.67
2023-0402.93
2023-0504.5
2023-0604
2023-0702.86
2023-0801
2023-0904
2023-1001
2023-1101.67
2023-1201.25
2024-0101.33
2024-0201.5
2024-0301.75
2024-0402.83
2024-0503
2024-0704
2024-0801.5
2024-0901.25
2024-1002
2024-1102.33
2024-1205
2025-0101.5
2025-0201.5
2025-0301
2025-0403.5
2025-0506.4
2025-0605
2025-0701
2025-0804.5
2025-0901
2025-1001.25
2025-1102
2025-1203.14
2026-0102.5
2026-0201.4
2026-0301.75
2026-0401.5
2026-0505
2026-0601.83
This device (reports/month)Average device in JDQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K031162 — cited as predicate by K173910, K201497, K203405, K223762

K211176 — cites (transitively): K002747 (d1), K002996 (d1), K021673 (d1), K021803 (d1), K022556 (d1), K022902 (d1), K022958 (d1), K023302 (d1), K023743 (d1), K033442 (d1), K040680 (d1), K052792 (d1), K070278 (d1), K070756 (d1), K071160 (d1), K072817 (d1), K072852 (d1), K081124 (d1), K083566 (d1), K083762 (d1), K092386 (d1), K093363 (d1), K093991 (d1), K100412 (d1), K100481 (d1), K102370 (d1), K103256 (d1), K110101 (d1), K110135 (d1), K113848 (d1), K120211 (d1), K121627 (d1), K122244 (d1), K122296 (d1), K123012 (d1), K130728 (d1), K143739 (d1), K150790 (d1), K151902 (d1), K160923 (d1), K162303 (d1), K171073 (d1), K171934 (d1), K182109 (d1), K182535 (d1), K791125 (d1), K823723 (d1), K823727 (d1), K831884 (d1), K896580 (d1), K900628 (d1), K914878 (d1), K920430 (d1), K921400 (d1), K932755 (d1), K934353 (d1), K960094 (d1), K962541 (d1), K963486 (d1), K963509 (d1), K970337 (d1), K970351 (d1), K971414 (d1), K983834 (d1), K990369 (d1), K990666 (d1), K991485 (d1), K061253 (d2), K062408 (d2), K071535 (d2), K082844 (d2), K062148 (d2), K083116 (d2), K050937 (d2), K060630 (d2), K113789 (d2), K042127 (d2), K052426 (d2), K954935 (d2), K961939 (d2), K102019 (d2), P040033 (d2), K111635 (d2), K122139 (d2), K162641 (d2), K061067 (d3), P960054 (d3), K033273 (d3), P960047 (d3) — cited as predicate by K231448, K240783, K242272, K250921

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